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GAMP® 5 Second Edition: What you should know

Gianna De Rubertis

Published on

September 2022

• Availability and usage
• Author-date style
• Notes and bibliography style
• History of editions
• Recent printed editions

Professionals in the health and life sciences industry have been using the GAMP® 5 Guide as a trusted framework for compliant GxP computerized systems since 2008. Geared toward an industry that thrives on innovation and the use of emerging technologies, the ISPE recognized that its GAMP® 5 Guide (First Edition) was in need of a touch-up to clarify and add guidance for new and trending topics – and with that, the GAMP® 5 Guide Second Edition was published in July 2022.   

In a nutshell, GAMP® 5 is a guide that provides direction for achieving compliant GxP computerized systems that are fit for intended use. The framework defined in GAMP® 5 deliberately sets out to safeguard patient safety, product quality, and data integrity in the use of GxP computerized systems, all while delivering business benefit.   

GAMP® 5 explains how compliance with regulatory requirements and fitness for intended use may be achieved by adopting a lifecycle approach. The extent of lifecycle activities should be patient-centric, risk-proportionate, and scalable according to (1) system impact on patient safety, product quality, and data integrity, (2) system complexity and novelty, and (3) the outcome of supplier assessments. Informed decision-making, risk management, and good judgment contribute to determining where and how to scale lifecycle activities.  

The new edition of GAMP® 5 continues to honour the main concepts and principles that were made sacred in the original version, with some notable improvements. Below, you'll find just some of the interesting perspectives and changes brought forward in the new edition:

The lifecycle approach is not inherently linear

• Use critical thinking to select an appropriate approach
• Use appropriate tools and systems for documentation and information management
• Enable innovation

First impressions

While a defined lifecycle approach remains important, GAMP® 5 now emphasizes and states very clearly that the approach is not inherently linear. Iterative and incremental approaches are fully supported and even encouraged when it makes sense. A linear approach (such as V-model or waterfall) remains appropriate for projects where requirements are fully known and defined upfront (e.g. acquisition of off-the-shelf equipment), but for projects that involve complex configurations or custom development of software, non-linear approaches (such as Agile) may be more effective. A new appendix is introduced in the GAMP® 5 Guide Second Edition to specifically address Agile software development (Appendix D8).  

Use critical thinking to select an appropriate approach  

By definition, critical thinking is the objective analysis and evaluation of circumstances in order to make a sound judgment. Solid understanding of the product at hand and knowledge of the business process in which it is used are key.   

Relevant lifecycle activities should be determined based on risk, novelty, and complexity. Not all lifecycle activities will (or should) be applied to every system in the same manner. Not all lifecycle activities will (or should) be applied in different organizations in the same manner. Context matters. The knowledge and experience held by subject matter experts (SMEs) and suppliers alike should be solicited and leveraged to proactively identify and assess risks, implement controls, and to adjust the lifecycle approach accordingly.  

The selected lifecycle approach can be optimized by applying critical thinking. For example:   

• Critical thinking can be applied during supplier assessment and selection. Knowledge of the processes followed by the supplier and outputs of supplier activities can be leveraged by the regulated user to reduce their own validation activities. Detailed specifications may not need to be recreated and system testing may not need to be reproduced in its entirety when that information is available from the supplier and is deemed suitable.  
• Critical thinking can be applied to identify effective testing approaches and to streamline the testing process. For example, you may decide that explicit installation and configuration verification is not required for standard systems because this is implicitly verified during requirements testing. The system would not exhibit the desired behaviour if it were not installed and configured correctly.  

Flexibility should be built into lifecycle processes to accommodate and promote critical thinking. A new appendix is introduced in the GAMP® 5 Guide Second Edition to specifically address this topic (Appendix M12).   

Use appropriate tools and systems for documentation and information management  

Regulatory authorities like to see scaled and targeted activities, with rationales supported by critical thinking. Information and records should be well-organized and have an appropriate level of detail. Maintaining information and records in appropriate software tools and systems is encouraged. These tools and systems could include electronic trial master file solutions, such as Montrium's   eTMF Connect .

Tools like these provide numerous benefits (such as: searchability, safeguards against unauthorized access to data) over traditional paper documents. There is no need to create traditional documents simply for the sake of having a document, provided the required information exists and is accessible when needed. A new appendix is introduced in the GAMP® 5 Guide Second Edition to specifically address software tools (Appendix D9).   

Enable innovation  

Regulatory requirements shall not hinder innovation. Technologies evolve at a rapid pace and their benefits should be embraced. With the evolution in technologies, GAMP® 5 has been updated to reflect modern terminology. Throughout the guide, vocabulary has been upgraded to better align with ITIL and to reflect language that is commonly used in newer areas such as cloud , distributed ledger systems ( blockchain ), and artificial intelligence and machine learning (AI/ML). New appendices are introduced in the GAMP® 5 Guide Second Edition to specifically address blockchain (Appendix D10) and AI/ML (Appendix D11).   

At Montrium, we operate as an Agile organisation overseen by a structured quality system. Our cloud-based infrastructure (Microsoft Azure IaaS) is managed by automated tools. Our software development lifecycle follows an iterative approach that includes feature definition, code review, and testing. In place of paper documents, Azure DevOps is used to document and manage risk assessments, requirements, and release pipelines. The Connect products developed by Montrium are subject to unscripted (informal), automated and scripted testing prior to release. Additionally, requirements testing is performed and documented. We encourage Connect subscribers to review and leverage our documented test results in place of traditional user acceptance testing. We believe these activities generate high quality and high value while being cost effective for our subscribers.  

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The 10 key changes in the GAMP 5 Second Edition

The GAMP 5 Second Edition, the newest version of the ISPE's computerized system guidance, was released in July 2022, replacing the First Edition unveiled in 2008.

The GAMP 5 Second Edition should be seen as part of a broader industry trend taking place: the evolution from computerized system validation (CSV) to computerized system assurance (CSA).

In keeping with the broad emphasis shift to agile, risk-based adoption of modern digital tools for GxP -regulated businesses, the Second Edition has brought 10 key changes to how 'good automated manufacturing practice' is defined.

We sat down with GAMP editor Sion Wyn to take a look.

What's new in the GAMP 5 Second Edition?

1. non-linear recognition.

The First Edition of GAMP 5 assumed a broadly linear approach to software development, which no longer reflects how modern software is brought to life.

The Second Edition recognises the largely non-linear, agile and more cyclical nature of modern software development.

Iterative, incremental and exploratory models are therefore emphasized over older, linear models like the waterfall.

Credit: hackr.io

2. Document change

The recognition of non-linear software development has a natural knock-on effect.

Legacy GAMP validation documents which assume a linear software approach, like installation, operation and performance qualification documents, are no longer relevant for the Second Edition.

There's therefore a shift in emphasis from traditional documents like IQs, OQs and PQs to risk-based records of information, held in appropriate systems, that take into account the modern software lifecycle.

3. Critical thinking

Critical thinking is a huge cornerstone of computerized system assurance, both in the GAMP 5 Second Edition and the FDA's new guidelines unveiled in September 2022.

Rather than one-size-fits-all, document-heavy approaches to validation, the GAMP 5 Second Edition encourages appropriate, efficient and risk-based assurance dependent on the risk profile of the software you're implementing.

The document crystallizes around the concept of critical thinking in a way the First Edition doesn't, including guidance of key areas of computerized system adoption where critical thinking should be applied, and a fresh appendix on the topic.

4. Update of development appendices

The areas of GAMP 5 focusing on user requirements specifications (URS) and functional/design specifications have been tweaked to reflect the new world of modern, agile software.

5. Appendix on electronic production of records updated

The rise of cloud-based technology and blockchain has been taken into account. The appendix also clarifies new expectations around electronic records, signatures and audit trails.

Multiple appendices have been updated to reflect the modern ITIL approach to software development, and to clarify links between key areas like change and incident management.

7. New appendix about blockchain and distributed ledger technology

Alongside the tweaks to the electronic production of records section, the Second Edition of GAMP 5 also contains an entirely new appendix taking blockchain and ledger technology into account.

8. New appendix about AI and machine learning

The GAMP 5 Second Edition acknowledges the increasingly significant role played by artificial intelligence (AI) and machine learning, and adds a new appendix to deal with the topic.

9. New appendix about use of agile within a GxP environment

Agility is a core ingredient of the Second Edition. Alongside the recognition of agile software development, GAMP 5 encourages an agile, critical thinking- and risk-based approach to assurance of digital tools.

A new section has been added to clarify these new expectations.

10. New appendix about modern infrastructure and infrastructure management

The replacement of paper with automation and AI is a seminal, defining change for how life science companies manage quality and compliance.

The Second Edition contains a fresh appendix outlining the modern GxP infrastructure, and how new digital tools should be implemented and applied.

Watch the video

Hear Sion explain more about the key changes in the GAMP 5 Second Edition in our interview video:

Learn more about computerized system compliance

Don't know your CSV from your CSA?

Drowning in IQs, OQs and PQs?

Worried what your FDA inspector will expect to see?

Download our complete guide to computerized system compliance in 2022 to get yourself up to speed on the GAMP 5 Second Edition and a range of other topics.

Alex has worked in the quality and compliance space for 5 years, producing a range of industry content to help Qualio blog visitors understand the complex and highly regulated environments of modern life science. Since graduating with a master's degree from the University of Cambridge, Alex has produced training courses, webinars, whitepapers, blog posts, e-books and more on a range of life science quality topics, from GxP to ISO 13485. Alex is passionate about the transformational power of a culture of quality and writes extensively about digital quality management, life science company growth and easing compliance burden.

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How Critical Thinking Can Improve Computerized Systems’ Compliance

Prerequisites for critical thinking and when to use the approach during daily operations.

The Foundation for Critical Thinking  defines critical thinking  as the “intellectually disciplined process of actively and skillfully conceptualizing, applying, analyzing, synthesizing, and/or evaluating information gathered from, or generated by, observation, experience, reflection, reasoning, or communication, as a guide to belief and action.” GxP compliance manager Charlie Wakeman simplifies that in an  ISPE blog  by explaining critical thinking as “focusing on what matters.” By prioritizing quality over compliance and documentation, actions taken with a focus on improving quality naturally lead to compliance.

To encourage employees within a life science organization to apply critical thinking in their daily work, organizations must grant permission within the Quality Management System and validation policy. This can be done using templates or by providing format options that cover essential elements and their activities.

GAMP 5 guidance encourages organizations to focus validation efforts on the most critical functions of the software application. This begins with its application during the planning phase. Using process mapping and diagramming tools can help identify and understand implementation risks. For example, a critical thinking approach can verify that there is a full understanding of how data flows to ensure data integrity in all process steps.

Defining specific requirements is a key task for the implementation of computerized system functionalities. Critical thinking can ensure that requirements related to regulatory compliance fit the system´s intended use. One example of applying critical thinking during the requirement specification is defining the need for an audit trail for GxP-regulated records.

For the use of software “as a Service” solutions, GAMP 5 recommends a supplier assessment with a focus on long-term provision and stability. By using critical thinking, organizations can determine that their supplier´s services fit the regulated company’s intended use. This in turn can help companies ascertain that the service provider adopts appropriate controls and maintains required records within their Quality Risk Management.

When it comes to managing data, multiple systems can be involved in a single data lifecycle, from generation through data processing to archiving. Critical thinking should be applied to consider how best to manage this interplay between computerized systems and the data life cycle.

Testing is fundamental for verifying that a system is working as expected, as this is needed to identify and correct possible deficiencies. The application of critical thinking can facilitate and optimize the test approaches. And, with thoughtful planning and organization of these tests, they can be combined or grouped into related functional tests to increase your team’s efficiency.

Computerized systems should constantly be tested, reviewed, and developed to improve patient safety, product quality, and data integrity. Faced with the associated validation and documentation burden, the application of critical thinking provides a structured and efficient approach for all regulated organizations. This avoids using outdated or unsupported operating systems and the associated security risks.

Without critical thinking, there is a risk of excessive work and insufficiency with the potential to blow the calculated budget and time delays. Successful implementation and application are therefore essential for pharmaceutical companies to remain competitive. However, this often depends on the mentality of the organization and its ability to build and maintain a company-wide critical thinking culture and understanding. With our extensive experience in the regulatory environment, GxP-CC lives these values and applies its critical thinking skills to every engagement.

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GAMP 5 update: computerized system expectations for pharma manufacturers

Posted: 16 November 2022 | Charlie Wakeham (GAMP Global Council) , Lorrie Vuolo-Schuessler (GAMP Americas Steering Committee) , Stephen Ferrell (GAMP Steering Committee) | No comments yet

The International Society of Pharmaceutical Engineering’s GAMP ® 5 guidelines steer validation practices for pharma companies to meet computerized system expectations. Members of the GAMP steering committees, Lorrie Schuessler, Charlie Wakeham and Stephen Ferrell, share the some of the key changes in the second edition update and how these should be interpreted by those working in pharmaceutical manufacturing.

Since 1991,  GAMP ® –  a community of practice within the International Society for Pharmaceutical Engineering (ISPE) –  has set the tone for the validation practices necessary for regulated pharmaceutical companies to meet the computerized system expectations of the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), the World Health Organization (WHO), the Medicines and Healthcare Regulatory Agency (MHRA) in the UK, the Chinese National Medicinal Products Administration and other global regulatory bodies. Since their outset the GAMP guides have promoted using a balanced risk-based pragmatism to achieve compliance and the July 2022 release of GAMP 5 second edition strongly encourages the use of critical thinking to support that.

As ISPE GAMP 5 Second Edition notes in the preface “Operating in a highly regulated industry may lead practitioners to apply prescriptive and rigid compliance-based approaches that are not commensurate with and not effective in managing any actual risk to the product and the patient.” 1

The validation of computerized systems should be focused on ‘intended use’ and scaled commensurate with the risks to patient safety, product quality and data integrity”

The focus until now has too often been on compliance and not on quality. The industry approach to validation has in some cases been overly burdensome, despite the best effort of the GAMP Community of Practice, the US FDA and other regulators to reinforce through presentations and guidance that the validation of computerized systems should be focused on ‘intended use’ and scaled commensurate with the risks to patient safety, product quality and data integrity. Validation projects have often been documentation-focused exercises, more befitting a grammar exercise than artifacts supportive of regulated activity.

The original iteration of ISPE GAMP 5 was released in 2008 arriving in the nascent stages of what has become the cloud revolution and certainly before the widespread adoption of agile development methodologies, meaningful augmented reality, machine learning and artificial intelligence use cases in the life sciences industry.

Given the rapid acceptance of ‘as-a-service’ software models and significant outsourcing of previously in-house IT functions, there was a feeling that there was a need to assess and update the guidance.

Given the rapid acceptance of ‘as-a-service’ software models and significant outsourcing of previously in-house IT functions, there was a feeling that there was a need to assess and update the guidance. The original GAMP core principles are now applied more broadly by the Second Edition to allow contemporary and competent practitioners the freedom to employ innovative and evolving technologies without the previously assumed documentation burden. 

While much software development now follows a more agile approach, changes – in the form of updates to the operating environment and software applications – are now frequent and essential to sustain data integrity and data security as well as operational efficiency. This required a paradigm shift from the previous ‘validate the system and keep it static and unchanged for as long as possible’ mindset to a dynamic and flexible approach to maintaining the system in a validated state of control throughout its operational life. Moving from ‘snapshot’-type qualification activities to real-time monitoring and control for the IT infrastructure supports this flexibility.

Balancing regulations for weighing in a GMP quality control laboratory

Key changes to GAMP 5

For the purposes of this discussion, we will focus on what we consider to be the most significant changes to GAMP 5 but we would encourage the reader to review the guidance in its entirety within the context of their regulated business activities. The GAMP 5 Second Edition includes:

• Six completely new appendices
• Significant updates to three of the original appendices
• Removal of a further three appendices.

This article primarily discusses Appendix D5 Testing of Computerized Systems and Appendix M12 Critical Thinking. Taken together these appendices provide the validation practitioner with broad contemporary thinking that can be applied to their day-to-day project activities.

Testing of Computerized Systems – Appendix D5

The validation of commercially available software applications has largely followed the GAMP V-model. While that model remains relevant from a planning and workflow perspective, ISPE GAMP 5 Second Edition is fully supportive of agile development and iterative testing methodologies and practices.

The GAMP 5 Second Edition guide emphasises that focus should be on value-adding activities rather than documentation for documentation’s sake.”  

The GAMP 5 Second Edition guide emphasises that focus should be on value-adding activities rather than documentation for documentation’s sake. System information and test evidence still need to be captured but the format of the information captured can be flexible as long as it is attributable, protected against unauthorised changes and available when needed. There is also encouragement to use tools where possible to increase validation efficiency and defect detection.  

For example, previous approaches to documenting the execution of a validation test case may have required the tester to initial and date each step. ISPE GAMP 5 Second Edition encourages critical thinking to reduce the instances of initials and dates while still ensuring that the identity of the individual or individuals performing any test is known, transparent, and easily attributable.

Another common and wasted effort used in the past was to write test cases which were then informally run to confirm the validity of the scripted instructions before running formally to provide supposed evidence of the system’s fitness for intended use; repeating the same test cases does nothing for defect detection and instead just contributes to that generation of documentation that so many have mistakenly believed is core to validation.

The revision of Appendix D5 also includes an expansion of the computer software assurance concepts from the ISPE GAMP® RDI Data Integrity by Design guide, 2 Appendix S2 – Computer Software Assurance, in which the reader is encouraged to apply additional, non-traditional testing approaches, reflective of current software industry good testing practice, to challenge the system’s fitness for intended use. Ad hoc testing, error guessing, exploratory testing, and day-in-the-life testing are all introduced with the intention of increasing test coverage and rigour while simultaneously documenting less.  

The use of contextualised functional risk assessments is also highlighted to allow the validation practitioner to scale their test cases commensurate with the assessed patient safety, product quality or data integrity risk that a particular requirement manifests. 

The GAMP 5 Second Edition also provides a great deal of encouragement for regulated companies to leverage vendor documentation, stating “…testing may occur both in the vendor’s development life cycle and in the regulated company’s implementation life cycle”. This aligns well with newly-issued FDA draft guidance on Computer Software Assurance, which states: “Because the computer software assurance effort is risk-based, it follows a least-burdensome approach, where the burden of validation is no more than necessary to address the risk.” 3

Critical Thinking in GAMP 5 – Appendix M12

The new critical thinking appendix M12 provides perhaps the clearest insight as to contemporary thinking within the GAMP Community of Practice, and states that, “…while GAMP 5 promotes a risk-based approach to ensuring fitness for intended use, some practitioners do not apply sufficient thought to ensure the approach they are taking is customised and proportionate to the needs of different systems”.

Critical thinking should not be reserved just for the testing stages within a validation project, nor should it be constrained to just the validation project. Consider critical thinking as a cradle to grave approach, for example:

• Realising efficiency and robustness gains during system planning by focusing on what the system must do based on a business process map, defining what stages of the data lifecycle it is supporting and avoiding the pointless verbiage that so often creeps into system requirements.
• Contextualising risk management, that is to say, that not every risk is fatal, and that often remedial strategies can successfully lower risk to levels that would be considered acceptable and as low as reasonably possible.
• Tailoring system training around the routine tasks of the different system user types, ensuring that each user type is given training centered on their tasks and responsibilities.
• Providing ‘how to’ videos and wikis available at the point of use for the system, rather than relying on distributing printouts of long and complex written standard operating procedures (SOPs).

The concept of using widely available requirements management tools is further reinforced in this appendix. Validation practitioners are encouraged to consider the value proposition of all activities particularly in validation preparation, execution and review.

GXP requirements and system attributes are kept in sharp focus, and only those requirements that have a defined patient safety, product quality or data integrity impact should be subject to risk remediation treatments.

Takeaways from ISPE’s GAMP 5 Second Edition update

In conclusion, there should be no doubt that ISPE GAMP 5 Second Edition is the written equivalent of a rousing quality sermon. Compliance is the minimum viable product, but it is quality that is the minimum lovable product and ultimate goal of the Second Edition.

Arbitrary comments, excessive evidence gathering, and non-focused testing are roundly rejected by ISPE GAMP 5 Second Edition.”

The chapter leads, the contributing authors, the countless peer reviewers and the regulators named and acknowledged in ISPE GAMP 5 Second Edition collectively affirm that the non-value-added processes, and outputs that have crept into our profession should have their necessity and providence thoroughly challenged. Arbitrary comments, excessive evidence gathering, and non-focused testing are roundly rejected by ISPE GAMP 5 Second Edition. The guide itself is utterly unambiguous, and all but the most determined will struggle to find multiple meanings within its chapters and appendices.

ISPE GAMP 5 Second Edition provides us with a clear concise pathway to drive our technology solutions in support of product quality and then subsequently maintain them in a validated state of control throughout their operational life. In this way, validation transforms from a perceived burden into a facilitator for the safe use of innovative technologies and processes.

• ISPE GAMP 5 Second Edition : A Risk-Based Approach to Compliant GxP Computerized Systems, ISPE, 2022.
• ISPE GAMP, RDI Good Practice Guide: Data Integrity by Design, ISPE, 2020.
• FDA, Computer Software Assurance for Production and Quality System Software – Draft Guidance. FDA, 2022.

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#Quality Management

GAMP 5 and GAMP 5 2nd Edition: What are the main differences?

Why GAMP 5 Needed a 2nd Edition

GAMP 5 (Good Automated Manufacturing Practice) is a risk-based approach for the implementation, operation, and validation of GxP Computer Systems in regulated industries – including the Life Sciences.

Recent technological advances have forced many organizations to rethink their business models once they realized a noticeable number of activities and documentation no longer added value to their company.

That is why GAMP 5 2nd Edition, published in July 2022, is the most significant update in over 14 years. Its objective was to update guidance to contemporary practices and specifically eliminate burdensome approaches.

The 2008 legacy GAMP 5 focused too much on compliance and on avoiding inspection findings rather than advancing products and processes through new technologies. With the 2nd Edition, a novel critical thinking methodology has emerged as a cornerstone of the guideline. Now, the approach is more oriented toward patient safety, product quality, and data integrity.

Structure of the New GAMP 5 2nd Edition

GAMP 5 2nd Edition consists of a main body text and several supporting appendices. The main body is the framework that provides guiding principles and a lifecycle framework applicable to GxP regulated computerized systems. The appendices support the main body and provide specific practical guidance on various topics. Some details have been updated in this new edition, while others are new; three of them have been retired and incorporated in other appendices.

The following is a summary of the main changes in the GAMP structure :

Particularly, the following key topics have been refined and strengthened in the updated edition:

• Focus on patient safety, data integrity, and product quality
• Process and product understanding
• Lifecycle approach within a quality management system (QMS)
• Scalable lifecycle activities
• Science-based quality risk management
• Leveraging supplier involvement

Others have been updated to include current technology (artificial intelligence (AI), machine learning (ML), and blockchain).

The key concepts of the general framework have been maintained. Some appendices have been updated and other new appendices have appeared for the first time in GAMP 5 history.

Overall, these changes were made after considering novel technology, new processes, new topics, and technical topics that required an update in management, development, and operations guidelines.

Overview of GAMP 5 2nd Edition

GAMP 5 2nd Edition is based on one key goal: to “protect patient safety, product quality, and data integrity by facilitating and encouraging the achievement of [computerized] systems that are effective, reliable, and of high quality.”

The main issues highlighted in GAMP 5 2nd edition surround innovation, critical thinking, agile methodologies, and IT service management. The guidance shows a clear evolution from Computer Systems Validation (CSV) to Computer Software Assurance (CSA) .

Linear Approach vs. Agile Approach

The 1st edition of GAMP 5 published in 2008 suggested a linear approach for the development and validation of software. That made sense in the early 2000s, when software was still static and releases were less frequent: You bought an application, you installed it on your system, and validation (via CSV) was completed in a one-and-done process. Back then, the so-called V Model was the most used approach to develop and validate a computerized system during its lifecycle in GxP environments. The V model is a waterfall model, where the development and testing activities go together linearly. It comprises the following sequential steps:

Today, GAMP 5 2nd Edition suggests an agile approach, which is non-linear. It represents a cultural and mindset shift. Current modern software development uses an iterative, incremental and exploratory approach. This approach is more of a cyclical process. The waterfall V model is not necessarily the most convenient approach anymore.

The left side of the V Model includes the verification activities (URS, Functional Specifications, Design) and the right side includes the validation activities (Unit Testing, Integration Testing, System and Acceptance Testing). These two sides are connected through the Development Stage.

The Agile Model requires a discovery mindset, rather than a certainty mindset. The discovery mindset enables us to manage learning and adaptation throughout the development lifecycle in a controlled way:

As most of the applications we use today in quality management systems are cloud enabled, the reality is that software is no longer static like it was back in 2008. Improvements are constantly being applied to your QMS and other software.

The agile model is useful because it is iterative, incremental, and exploratory. Additionally, the use of risk-based methodology helps with ensuring full compliance with this new methodology.

Paradigm Change: From Documents to Tools and Systems

We are moving away from traditional paper documents and toward keeping records and information in tools and systems.

In the early 1990s, the GAMP guide was mainly used to control suppliers of manufacturing production equipment to the pharmaceutical industry. Thus, the V model was used in the first four versions of the GAMP guide from 1994 to 2008. This V model worked very well for manufacturing equipment and equipment with computer control elements with simple configuration. But there are better-suited alternatives now.

With the recognition of agile methodology in GAMP 2nd Edition as a non-linear approach for software development and validation, legacy validation documents from GAMP 1st Edition, such as installation (IQ), operation (OQ), and performance qualification (PQ) documents, are no longer relevant.

Critical Thinking

A new appendix (M12) has been included in GAMP 5 2nd Edition. Critical thinking is the most interesting addition to this new version. It is a basic pillar of the guideline. Critical thinking is now aligned with the new FDA guidance “Computer Software Assurance for Production and Quality System Software” that has been published in September 2022.

The appendix encourages the application of critical, patient-centered, risk-based thinking to software assurance.

Infrastructure

A new appendix (M11) has been included in GAMP 5 2nd Edition. Modern management approaches, using automation tools appear in the guideline:

• Artificial Intelligence
• Cloud technology

The appendix also clarifies new expectations around electronic records , signatures, and audit trails.

ITIL Approach to Software Development (IT Infrastructure Library)

All operation appendices have been brushed up and updated to reflect an IT QMS item approach, leading to more clarity in change management vs. problem management vs. incident management.

Main Changes in GAMP 2nd Edition

Changes in the introduction.

Specific emphasis is given in this new version to apply critical thinking and risk-based approaches as a cornerstone to safeguard patient safety, product quality, and data integrity in the use of GxP computerized systems. Now, compliance is longer the only focus of the guideline.

The guidance is now aligned with ISO 14971 for medical devices – application of risk management to medical devices and agile approach for development and validation.

The introduction covers the justification for updating most of the technical content of the guideline, not the main framework, to include the importance of IT providers, agile methodology, the use of software tools to be used throughout the lifecycle, the inclusion of artificial intelligence and machine learning (AI/ML), blockchain, cloud computing, and Open-Source Software (OSS).

The general framework, key concepts, system lifecycle, specification, verification approach, and Quality Risk Management (QRM) process remains unchanged.

M11 - IT Infrastructure

This is an appendix that was originally identified as Appendix S5 in the first edition. This appendix applies current risk-based thinking on good practices for managing the infrastructure that resides within a regulated company’s own facilities as well as to external suppliers based on the cloud (IaaS, PaaS, and SaaS).

Infrastructure must be managed to a controlled state. Both confirmation of components’ fitness for purpose and management to a controlled state are likely to involve automated processes.

The guideline suggests QA to have a reduced oversight in some minor changes, by having an agreement between IT and QA with a standard change list without the need of a formal change control, for example, when there is a need to perform a change with low-risk.

M12 - Critical Thinking

This is a new appendix. Critical thinking is in favor of applying sufficient thought to ensure the approach taken is customized and proportionate to the needs of different systems.

A pragmatic approach is promoted that is against over-compliance and against activities that are non-value-added compliant. It is also against the use of rigid tables, predefined templates, and tick-in-the-box methods that could inhibit innovation and the adoption of new technologies.

A good practice is to map and understand processes. Risks should be found to ensure that the computerized system is fit for purpose with the best implementation strategy.

Critical thinking can be applied in all activities related to validation (preparation, execution, and review) to consider which activities add value. Only added-value activities should be considered for remedial actions. Here, more really is less.

D1 - Specifying Requirements

There is a significant update to this appendix. The legacy GAMP 5 1st Edition contained separate appendices for User Requirement Specification (URS) and FRS (Functional Requirements Specifications). Now they are combined into this appendix D1.

The main revision is about the use of Agile development methods and the use of tools and automation in the capture and definition of requirements. Requirements specifications can now be maintained in an appropriate management tool or in a document, depending on your methodology (agile V model).

All requirements are to be categorized and prioritized based on criticality to patient safety, product quality, and data integrity.

D5 - Testing of Computerized Systems

There is a significant update to this appendix, mainly related to the concept of computer software assurance (CSA). The appendix covers the testing of GxP computerized systems, offering information on the types of testing approaches that can be used for optimal assurance that the system is fit for its intended use. Testing should be limited in the use of GxP cases based on risk assessment .

Now, more testing is more important than more documentation. An example of this is the adoption of an exception-reporting approach to recording results. This means that if the system is working as intended, a simple “Pass” recording is enough. There is no need to capture excessive screenshots as evidence in most of the tests. Only those tests that are critical may require additional screenshots as evidence. It is better to focus on unexpected issues to find the root cause and apply the proper corrective action. This is more valuable.

The guidance mentions that looking for minor errors in documentation gives little value and poses a low risk to patient safety, product quality, and data integrity. Hence, it is better to focus on other issues.

Regarding validation packages from suppliers, they can be effectively leveraged to satisfy the GxP verification requirements to avoid duplication. This acts as an additional layer of assurance. There is no reason not to use the validation package from the supplier: The more you can leverage the better.

Regarding the person that executes the testing, GAMP 5 requires identifying who is performing the tests, as the quality of testing is significantly impacted by the knowledge and skill of the tester. At the same time, GAMP 5 states it is unnecessary to use test witnessing or to require the tester to initial every single test step to affirm they followed the instructions. A final signature at the end of the page is enough.

D8 - Agile Software Development

This is a new appendix. The focus is on how to use agile processes to deliver software for GxP applications without modifying the agile methodology according to GxP requirements, for example, by superimposing linear (V model) activities.

Some organizations are purchasing Software as a Service (SaaS) products from companies that are using agile software development, like the Jira tool. These companies are able to be agile to continually improve. They push updates while the regulated customer maintains the compliance state.

With agile, teams can deliver effective and useful software in a controlled way that is compliant with GxP regulations. It is a different mindset where discovery encourages acting, learning, and rapid continual improvement.

The guideline describes that the planning, specification, verification and reporting activities are not inherently linear. Agile is compatible with other incremental, iterative, and exploratory models and methods.

Software development using an agile approach discovers and iterates ongoing changes as opposed to waterfall software development, used in the legacy guideline GAMP 5 1st Edition.

In addition, GAMP 5 2nd Edition clearly states that 21 CFR Part 11 is not applicable to the approval process of Agile methodology, as the approval is not equivalent to a traditional handwritten, which is a legally binding signature required by a predicate regulation. In other words, only Part 11 records need a special level of scrutiny.

The approval of software lifecycle deliverables can also be achieved by many other means (e.g., status change, email, audit trails).

D9 - Software Tools

This is a new appendix that applies to softwares that are not components or applications in a GxP-regulated business process, like Jira. As they cannot directly impact GxP data/records, the predicate rules do not apply.

The guideline states that tools used in computerized systems lifecycle processes, IT processes, and IT infrastructure processes do not require computerized system validation. They can be managed by good IT practices. Instead, you can perform an IT risk assessment and procurement practice instead of formal validation.

D10 - Distributed Ledger Systems (Blockchain)

This is a new appendix. Currently, blockchain technology is not yet widely implemented in GxP environments. However, blockchain technology could be used for very specific applications, such as the recording and tracking process and product activities across the product lifecycle, from the purchase of raw material to the final consumer, giving high security and transparency. An application could be for the use of audit trails, and public or private networks.

D11 - Artificial Intelligence and Machine Learning

This is a new appendix. Artificial intelligence (AI) and machine learning (ML) are new technologies to automate many functions previously performed by humans. As long as you are able to define the boundaries of the AI and ML algorithm and the use case, the system can be validated. The use of key performance indicators acts as the technical specifications for the acceptability of the ML model.

S2 - Electronic Production Records

Due to the evolution of novel technologies, this appendix was updated significantly. There is more clarification on data audit trails and the frequency of data audit trail review according to predicate rules and also for non-cGMP data.

Risk-based methods are to be used to define which audit trails should be reviewed and at what frequency.

Regarding backup and recovery of electronic data, it is basic to define the recovery point objectives (RPO) that dictate the frequency of backups, and the recovery time objectives (RTO) that dictate the interval between system failure and recovery. This period of time is expected to be in line with the system risk assessment.

Which Appendices Have Been Retired?

Appendix d2 functional specifications.

Appendix D2 Functional Specifications has been retired. The content has been incorporated into Appendix D1 Specifying Requirements.

Appendix O7 Repair Activity

Appendix O7 has been removed. Repairs are to be managed as standard changes, service requests, and/or system administration tasks. The requirements for repair activities are now defined in Appendix O6.

Appendix S5 Managing Quality within an Outsourced IS/IT Environment

Appendix S5 has been withdrawn. The revised content has been included in Appendix M11.

1 ISPE. (2022). GAMP5, 2nd Edition, Section 1.1 Rational for GAMP5 Second Edition.

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The Main Differences between 1st and 2nd Editions of GAMP® 5

by: Nicole Höger Regional Operations Manager DACH Area & Senior Associate Partner @PQE Group

CSV & Data Integrity

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Introduction to the New Edition of GAMP® 5

The new version of GAMP® 5 was issued in order to update several areas of content included in the previous 14-year-old version, as there was a need to implement the technical and methodological changes that have taken place in recent years.

In particular, this guideline implements the concept of Critical Thinking, which has also been dealt with in other guidelines. Critical Thinking is outlined in a new appendix explaining its application through the system development life cycle and all supporting processes.

Introducing the Concept of Critical Thinking and Unscripted Testing

The new concept has been introduced in order to reduce the amount of unnecessary effort and documentation and to redirect the focus of demonstrating the validated and reliable status of a system towards a new direction: the system’s fitness for its intended use.

• Leverage the testing effort during Computerized System Assurance
• Include, where possible, supplier's testing
• Focus on the SME's experience in testing and challenging the system

The concept of Unscripted Testing is strongly highlighted. Scripted tests are standard tests as previously described in the first GAMP® 5 Edition. Unscripted tests, on the other hand, can be of different types and structures, but all have the goal of challenging the system. In order to challenge the system, testers must be highly skilled at using the software in order to identify both expected and unexpected behaviors of the system.

Testing Approaches

A standard testing approach starts with the system’s specifications and is therefore mainly focused on positive testing , whereas unscripted testing is focused on the system’s and the user’s behavior.

Advantages:

• Positive Testing: Focused on system's specifications
• Unscripted Testing: Focuses on system's and user's behavior

On the other hand, scripted testing provides the best solution in order to perform regression testing due to the very high level of detail, however this testing approach challenges expected behaviors and strongly depends on the specifications : if the specifications are not written in a comprehensive way, testing will be executed with limitations and will not give adequate results. These considerations on the V-cycle can also be applied to the agile life cycle and are completely risk driven .

Updates in the New Edition of Pharmaceutical Guidelines

F urthermore , the new edition consider s the new technological improvements, new software development methods such as the agile method, and underlines the importance of suppliers especially from a cloud perspective. The concept of the supplier returns forcefully in all chapters, on the one hand in the form of the importance of audits and contracts , and on the other whe re it concerns greater attention to the use of tools .

This update is related to the fact that most of the information , when dealing with suppliers , is no longer contained on paper but rather within tools in the form of records. Other innovations that have been included in this new edition concern the state of the technological art , also in terms of blockchain, artificial intelligence, open source software and cloud computing.

All articles that have appeared over time on pharmaceutical engineering and topics of other guidelines that have been issued have also been incorporated. An additional main update covering the entire new edition includes a strong component for D ata I ntegrity , which has been the focus of pharmaceutical companies in recent years . Data Integrity is highlighted in all the paragraphs and appendices of the new guideline edition .

Significant Changes to the Appendices

With regards to changes to the appendices, which constitute the most significant part of the GAMP® guideline, an additional significant new appendix is one concerning IT infrastructure as well as one related to User Requirements Specifications (URS), which has been heavily modified the one which in the previous version was called "User Requirements Specifications" is called "Specifying Requirements" in the new edition, which incorporates the topics of the URS and the “Functional Specifications” (FS), which is the reason the appendix D2 on the "Functional Specifications" has been removed.

Further new appendices concern agile testing, aspects of software tools, and the blockchain and artificial intelligence. With respect to the new appendix on the blockchain, suggestions are described and guidelines for developing a large-scale blockchain system are offered.  

Evaluating Blockchain Systems and Artificial Intelligence in Software Development

The initial clarification of the chapter is said to critically evaluate blockchain systems because there are particular cases in which these systems can be considered as traditional systems or as six simple data containers. The first thing to do is evaluate the intended use and then consequently approach the project in a different way. The other new appendix concerning artificial intelligence provides indications and guidelines on how to manage these artificial intelligences and in particular, the machine learning included in other software products.

The differences between a normal system and this one, as well as machine learning, are underlined. The heart of this appendix revolves around the fact that machine learning systems are data-centric, therefore data becomes an integral part of both the development phase and the validation and maintenance phase. When approaching this type of system, the importance of data from the conception phase of the development of a machine learning needs to be kept in mind.

The O7 appendix , which was the one related to Repair, was withdrawn as the repairs were merged into other appendices (partly within the Operational Change, partly within the System Administration activity). Another appendix that has been heavily modified is the one related to Electronic Production Records , which has been updated to incorporate new technologies such as the blockchain, considerations on cloud systems and real-time release. The S5 appendix , which dealt with IT systems management, was withdrawn because it was included as a topic within the new IT infrastructure appendix.

The new Edition of GAMP5 covers a large amount of topics that have partially been addressed in complementary guidelines as well as partially newly introduced topics, triggered by the need for innovation, by the COVID-19 pandemic and by the fast evolution we are experiencing in recent years, from both a technological and a human point of view.

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News and Views

Gamp 5 second edition – the changes pharmaceutical laboratories need to know.

by John O'Sullivan | 30 Nov, 2022

GAMP 5 Second Edition is the first significant update to GAMP 5 since 2008. A lot has happened since then, with the development of new technologies that are now commonplace, as well as technologies that are becoming increasingly important. There have also been changes to best practices for the development of computerised systems. So, what has changed in GAMP 5 Second Edition and how will those changes impact your pharmaceutical laboratory ?

GAMP 5 Second Edition was released by the ISPE (International Society for Pharmaceutical Engineering) in July 2022.

Why Is There a Need for GAMP 5 Second Edition?

GAMP 5 is recognised across the world as the go-to guide for managing the compliance and validation of GxP computerised systems used in pharmaceutical operations . GAMP 5 covers the entire lifecycle of a computerised system, from commissioning and development to operation and updating to upgrading and retirement.

The aim of GAMP 5 is to help pharmaceutical companies “protect patient safety, product quality, and data integrity”.

The previous version of GAMP 5 achieved these aims but, in doing so, it also hampered innovation as technologies evolved. The new edition of GAMP 5 seeks to address this by facilitating innovation while still ensuring patient safety, product quality, and data integrity.

GAMP 5 Second Edition can be seen as part of the evolution from CSV (computerised system validation) to CSA (computer software assurance). In CSA, validation is risk-based and focused on patient safety and product quality, rather than being focused on documentation and box ticking.

GAMP 5 Second Edition is also better aligned with ITIL. ITIL, or Information Technology Infrastructure Library, is a framework for the full lifecycle management of IT services.

What Has Changed in GAMP 5 Second Edition?

Recognition of agile development.

The previous version of GAMP 5 assumed computerised system development was a largely linear process. This no longer reflects reality, as the development of modern computerised systems typically involves an iterative approach.

In GAMP 5 Second Edition, there is now a new appendix that covers the now commonplace iterative and agile approaches to the development of computerised systems.

The linear approach hasn’t been completely discarded in GAMP 5 Second Edition, as it is still applicable in some situations, including when using off-the-shelf software applications. Therefore, the traditional V waterfall model for the development of computerized systems is still available.

However, GAMP 5 Second Edition now also accommodates more agile and iterative development methodologies.

Changes in Documentation Requirements

The revised documentation requirements in GAMP 5 Second Edition are largely based on the recognition of agile development processes. The result is a change in focus away from traditional documents like IQs (installation qualification), OQs (operational qualification), and PQs (performance qualification).

GAMP 5 Second Edition instead requires a risk-based approach to documentation. It also facilitates a move away from traditional documentation creation, as there is now guidance on how records can instead be kept on tools and systems.

Focus on Critical Thinking

The introduction of critical thinking in GAMP 5 Second Edition aligns the updated guidance with the new guidelines on CSA released by the FDA in September .

Critical thinking involves moving away from prescriptive approaches to validation, where box ticking is the outcome and innovation is obstructed. A prescriptive approach to validation also does not reflect the reality of lifecycle activities, as those lifecycle activities are all different.

With critical thinking, context is taken into account using a risk-based approach that considers factors like complexity and novelty. The topic of critical thinking is covered in one of the six new appendices in GAMP 5 Second Edition

The New Appendices in GAMP 5 Second Edition

The above points have mentioned new appendices in GAMP 5 Second Edition. The appendices reflect the main changes between the original version of GAMP 5 and the new Second Edition.

In addition to the new appendices, there are also changes to some of the original appendices. Here is a summary of what is new and what has changed:

• New management appendices – IT Infrastructure (M11) and Critical Thinking (M12)
• New development appendices – Agile Software Development (D8), Software Tools (D9), Distributed Ledger Systems (Blockchain) (D10), and Artificial Intelligence and Machine Learning (D11)
• Amended and removed development appendices – User Requirements Specifications has been amended to Specifying Requirements (D1). Significant changes have been made to this appendix. Functional Specifications (previously D2) has been removed, with elements of this old appendix now incorporated into D1. Testing of Computerised Systems (D5) has received significant updates.
• Amended and removed operational appendices – Repair Activity (previously O7) has been removed, with elements of this old appendix now incorporated into Operational Change and Configuration Management (O6).
• Amended and removed special interest appendices – Managing Quality Within an Outsourced IS/IT Environment (previously S5) has been removed, with elements of this old appendix now incorporated into the new management appendix, IT Infrastructure (M11).

Why GAMP 5 Second Edition and Not GAMP 6?

In GAMP 5 Second Edition, the underlying approach to managing the compliance and validation of computerised systems remains the same. In fact, the only part of the main body text in the new guidelines that has been changed in any significant way is the introduction. Everything else is largely the same, with a few tweaks and clarifications.

What is different in GAMP 5 Second Edition are the appendices, as explained above. Therefore, GAMP 5 Second Edition maintains the overarching principles of the original guidance while also recognising and accommodating advances in technologies, processes, and infrastructure, both IT and OT.

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Guest Column | December 12, 2023

How does the gamp 5 second edition update look one year later.

By Sion Wyn, Conformity Ltd., and Heather Watson, TenTenTen Consulting Ltd.

We recently marked one year since the publication of the Second Edition of the ISPE GAMP 5 Guide: A Risk-Based Approach to Compliant GxP Computerized Systems , and we are taking this opportunity to pause and reflect. GAMP 5 is a widely used international guidance on GxP computerized systems validation and compliance. It is applied by regulated companies, suppliers, service providers, and regulators worldwide.

The First Edition was published in 2008, and as the 10th anniversary of its publication passed, it was time to consider whether an update was necessary. Surely, it was time to update the guidance to reflect technological progress in the intervening years. If so, which elements needed addressing, and equally importantly, which aspects were still relevant and up to date?

GAMP is close to both our hearts. Sion is a founding member of the GAMP Committee and is GAMP 5 editor, while Heather has served as the chair of the GAMP Global Steering Committee and recently assumed the role of chair of the GAMP Editorial Review Board. We felt privileged to co-lead, along with Chris Clark, the production of the Second Edition of GAMP 5.

GAMP documents are published by the International Society for Pharmaceutical Engineering (ISPE), which is a nonprofit association serving its members by leading scientific, technical, and regulatory advancement throughout the entire pharmaceutical life cycle. The ISPE GAMP Community of Practice (CoP) promotes the understanding of the regulation and use of computerized systems within the life sciences.

The GAMP Editorial Review Board carefully reviewed the GAMP 5 First Edition in the light of technological, regulatory, and industry changes, identifying areas and concepts that remain current and relevant, aspects that required updating to reflect current realities, and identifying new technical topics that needed to be addressed and where guidance was required.

Global Events Influenced GAMP 5 Second Edition Changes

We also considered societal changes and recent lessons learned. The global COVID-19 pandemic reminded us that innovation and technological advances are essential to safeguarding patient safety and public health, and that industry and regulatory flexibility is vital in meeting these key objectives. We hoped that GAMP 5 guidance could play a role in achieving this. The feedback at launch events and conferences worldwide has been extremely positive, with many participants welcoming the move toward a flexible, patient-focused approach, based on critical thinking, rather than focusing on compliance and inspections.

We have heard how the Second Edition has helped companies to be more comfortable and confident in adopting modern life cycle approaches, applying tools and automation, and in moving away from document-driven approaches toward knowledge management and defect prevention. Challenges facing us, however, include how best to explain and illustrate practical critical thinking, so that it can be more widely understood and applied.

The overall approach, framework, and key concepts remain unchanged from the First Edition. The technical content of the guide has been updated to reflect the increased importance of IT service providers including cloud service providers, evolving approaches to software development including incremental and iterative models and methods, and increased use of software tools and automation.

Guidance on the application of new and developing technological areas such as artificial intelligence and machine learning (AI/ML), blockchain, cloud computing, and open-source software (OSS) has been included or updated. The importance of critical thinking and the application of patient-centric, risk-based approaches (aimed at quality and safety) versus primarily compliance-driven approaches are further underlined. Concepts of computerized systems assurance as discussed as part of the U.S. FDA’s Center for Devices and Radiological Health (CDRH) Case for Quality program are also explored and applied.  Some key areas are explored below.

GAMP 5 Second Edition’s Life Cycle Approach

The Second Edition clarifies that the GAMP life cycle and specification and verification approach is not inherently linear; it also fully supports iterative and incremental (Agile) methods. New material outlines how critical thinking should be applied through the system’s life cycle.

The guidance explains how the life cycle phases apply in Agile situations as well as linear and encourages the maintenance of records and information in appropriate and effective software tools. The guidance also reflects the increased use of cloud-based applications.

IT Infrastructure In The Second Edition

A new appendix applies current risk-based thinking on good practice for managing infrastructure within a regulated company’s own facilities as well as those of external suppliers, such as cloud-based suppliers of Infrastructure as a Service (IaaS), Platform as a Service (PaaS), and Software as a Service (SaaS).

The Second Edition’s Focus On Critical Thinking

A new appendix discusses the application of critical thinking to proactively optimize the approach taken to ensure quality and compliance of computerized systems (through better specification, development, testing, operation, and maintenance) within the context of the business processes they support.

Computerized Systems Testing

Guidance has been updated to emphasize:

• Critical thinking should be applied when planning testing efforts. The regulated company should determine the type and level of assurance activities required, based on their own need to ensure systems are fit for intended use, commensurate to the risk acceptable within the organization as defined in its policies, procedures, and plans.
• Testing by any means and in any part of the life cycle and in any environment (development, validation, production, DevOps, etc.) all contributes to finding defects and confirming the system is fit for intended use.
• Testing should not be limited to detailed and prescriptive step-by-step scripted protocols. The use of exploratory testing and other unscripted techniques is encouraged to extend test coverage and improve defect detection.
• Using automated testing brings benefits to test coverage, repeatability, and speed. Modern approaches may rely on records, information, and artifacts in automated tools in place of formal specification and test documentation.

Agile Software Development

A new appendix provides a brief summary of the principles underpinning Agile and illustrates how it can be implemented in a way that is aligned with GAMP 5 and GxP principles. The focus is on how to use well-implemented standard Agile processes to deliver software for GxP applications and does not advocate modifying Agile for GxP, for example, by superimposing duplicate and unnecessary linear (“V-model”) activities.

Artificial Intelligence And Machine Learning

A new appendix provides an overview on applying a controlled system life cycle to these technologies, and guidance on how to ensure compliance integration and fitness for use in a GxP environment.

Encouraging Innovation And Good Practice

One of the reasons GAMP guidance has always been successful is that it has reflected the current good IT and software engineering practice, based on input from experienced IT, automation, and software practitioners. We must always ensure that GAMP guidance is well aligned with current good technical practice.

We cannot provide guidance based on or supporting technical concepts, approaches, or techniques that are in some cases decades old, even if they do sometimes remain enshrined in regulatory guidance or company policies and procedures. We would never consider applying old-fashioned, superseded, and outdated medical science or medical practices, and the same should be true for IT and software systems!

We do, however, still see too many examples of ineffective and inefficient practices for reasons including organizational inertia, lack of experience and training, compliance-driven tick-box approaches, and a misguided fear of perceived regulatory inflexibility.

We need to consider how we can encourage practical and effective critical thinking to address these issues, find innovative ways to explain the concept further, and provide meaningful examples, case studies, additional guidance, and training on the topic.

GAMP 5 Second Edition prioritizes patient safety and product quality over compliance and encourages the application of critical thinking. It strongly supports the FDA Center for Drug Evaluation and Research’s (CDER’s) vision of a maximally efficient, agile, flexible manufacturing sector that reliably produces high-quality drug products without extensive regulatory oversight, where the vision requires moving beyond simply meeting minimum cGMP standards and toward robust quality management systems.

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GAMP 5 2nd Edition - What is new? - Online Training Recording

Course No. 20668A

Yves Samson

Dr. Bob McDowall

R.D. McDowall Ltd.

Frank Behnisch

CSL Behring

Stefan Münch

Körber Pharma Consulting

Dr Robert Stephenson

Rob Stephenson Consultancy

• Get to know the differences between GAMP®5 and GAMP®5 2nd Edition.
• What are the changes in the main part?
• What are the changes in the management and Operation appendices?
• How has the 2nd edition been affected by new technological developments
• Critical Thinking in and about the 2nd Edition
• FDA CSA (Computer Software Assurance) and the 2nd Edition - how do the two fit together?

With GAMP®5, published in 2008, this guide became the globally accepted standard for the validation of computerized systems. Due to new technological (Artificial Intelligence / Cloud Computing / Agile Software Development) and regulatory developments (ICH Q9 / FDA initiative in CSA), there was a need for adaptations after 14 years. These adaptations have now been integrated into the 2nd Edition, which has been available since July 2022. The publication of a 2nd Edition instead of a completely new GAMP®6 shows that the basic principles of GAMP®5 are still relevant. In the 2nd Edition, changes and further developments have been made according to the motto evolution instead of revolution.

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• Quality Control / Quality Assurance
• Engineering

Technical Details

To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display. Timing and Duration: When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs. In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data. Please be aware: The recording does not include the Q & A sessions. Training Course Documentation and Certificate: The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.

• Critical Thinking
• Advancing Technology
• Enabling Innovation
• What has been retained?
• Significant revisions
• Key Messages
• Expected improvements
• Summarising Appendix M11
• IT Infrastructure changes in the 2nd editio
• General impact on CSV and GAMP®5 best practices
• Summary of new Appendix D9
• Enabling innovation, increasing quality
• Compliant selection and handling of tools for CSV
• What the industry oversaw (ignored?) during the last 20 years
• Enabling Innovation and GAMP®5 2nd Edition
• Quality Risk Management: the keystone process for Critical Thinking
• Practical application of critical thinking in projects and processes
• Differences between GAMP®5 1st and 2nd Edition
• Could system and equipment suppliers leverage critical thinking and CSA?
• Persistent expectations
• Supplier maturity: facilitating Leveraging Supplier Involvement
• Summary new appendix D11 & Life Cycle Approach
• Concept Phase
• Project Phase & supporting processes
• Individual statements from the speakers
• Panel discussion

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GAMP ® 5 2nd Edition

Critical thinking and agile software development as per gamp ® 5 2nd edition.

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The new version of GAMP® 5 was issued in order to update several areas of content included in the previous 14-year-old version to implement the technical and methodological changes that have taken place in recent years. Critical Thinking has been introduced and rolled out in the new guidance in order to reduce the amount of unnecessary effort and documentation and to redirect the focus of demonstrating the validated and reliable status of a system towards a new direction: the system’s fitness for its intended use. New approached to specifications issuing, testing execution and verification of the reliability and fitness for intended use of computerized systems are extensively described through the new approach with a strong focus on leverage the testing effort during Computerized System Assurance, include supplier's testing and rely on SME's experience in testing and challenging the system.

Another topic introduced in new version of GAMP® 5 is Agile Software Development. Agile approach helps regulated companies with less clearly defined requirements/ scope to commence with a discovery phase to develop an initial backlog requirement and enable faster initial system deployment and subsequent incremental developments. Agile is typically used with sets of tools providing quality/ GxP control over the product backlog, configuration, testing, and release activities enabling shorter cycle times, higher quality in delivery, better user engagement and demonstrating that the system is fit for intended use.

CONNECTING PHARMACEUTICAL KNOWLEDGE

Critical Thinking & Periodic Review

The drive within life sciences to improve patient safety and product quality, and provide value to society, while reducing costs requires constant and effective innovation. However, because the pharmaceutical industry operates in a highly regulated sector, some practitioners may apply unthinking, prescriptive, and rigid approaches that are not commensurate to the needs of the process, the nature of the system, and the real risk to the product and the patient. The NEW GAMP Good Practice Guide on Enabling Innovation will be presented during this webinar. Our speakers are:

• Tom De Rudder (Systems Team Lead at Novartis)
• Thierry Provinciael (Consultant Life Science Industry)

Tom De Rudder will discuss the new ISPE GAMP® GPG Enabling Innovation. Thierry Provinciael will guide you through the subject of Applying Critical Thinking on Periodic Review. We will close-out with an interactive discussion session, where you can share your ideas and opinion about this subject.

Attending the webinar is free for ISPE members. Non-members have to pay a fee of only €10,-. Registration is required.

We kindly ask all participants to create a (free) account on https://miro.com/login/  to participate in the discussion.

Event Properties

Tom DeRudder

Ispe gamp cop europe, vice-chair.

Tom De Rudder has +20 years experience in Pharmaceutical Industry with expert knowledge in Computerized Systems GxP requirements & validation. He works as Site eCompliance/Computerized Systems Team Lead at Novartis. He drives continuous improvement to meet and sustain compliance, also active as a volunteer in ISPE GAMP Community of Practice (GAMP Europe, GAMP Benelux, SIG Data Integrity, Pharma 4.0.).

Thierry Provinciael

Freelancer supporting pharma and medical device industry with csv and project management..

Experienced Senior Compliance Engineer and project manager with a demonstrated history of working in the Pharmaceutical industry. Skilled in Computerized System Validation, Requirements Analysis, data integrity and GxP. Strong quality professional with a Master in Industrial Sciences: Biochemistry from De Nayer Instituut.

We are no longer accepting registration for this event or you already registered

StarsInsider

Ways to improve your critical thinking

Posted: 26 March 2024 | Last updated: 27 March 2024

Critical thinking is an essential skill for anyone who wishes to be successful in business. It is what allows us to analyze information properly to find appropriate solutions to problems. But it is also important to think critically in every day life; it helps us to filter out fake news, for example.

While most of us have a certain level of critical thinking capacity, there is often room for improvement. Check out this gallery for some tips on how to improve your critical thinking.

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Understand the concept of critical thinking

Before you set about trying to build those critical thinking skills, it is important to first understand what exactly critical thinking is. Put simply, it is the ability to think about ideas and concepts in a critical way.

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It is the difference between accepting what you're told at face value and asking questions such as why you're being told that and what is the motivation of the speaker.

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Ask questions

It follows, then, that when learning to think critically it is important to ask questions. When you next read a report or listen to a presentation, try and ask as many questions as you can.

Although you run the risk of winding up the presenter, asking questions is in everyone's interest because it can help to expose weaknesses in logic and pave the way for a better solution to a problem.

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Question yourself

In addition to asking questions about the information in front of you, it is important also to question your own thoughts and actions on a regular basis.

Questioning yourself will help you identify behaviors that are unhelpful or self-defeating. All too often we continue with a certain behavior because it seems right, when in fact it is making things worse.

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Pay attention to all incoming information

It is paramount that you pay attention to all information coming your way, whether or not it comes from a source or person you agree with.

People without critical thinking skills tend to tune out information that they don't want to hear, when in fact people we don't like nearly always have something useful to say.

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Develop foresight

Good critical thinking always involves an element of foresight. Successful critical thinkers are able to use the information available to them to predict what will happen in the future.

However, foresight is not about clairvoyants and tarot cards. Instead it is about carefully considering all the possible consequences of a certain action.

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Reduce time-wasting

Critical thinking, like anything else, takes practice. It is therefore a good idea to rid your life of time-wasting activities, such as Netflix bingeing, so you have more time to practice.

That does not mean to say you shouldn't relax, however. In fact, the brain needs downtime in order to develop. Try and go for something more stimulating, though, like reading a book.

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Plan your day

The more you practice critical thinking, the more easily it will come. In the beginning, however, it takes time. It is therefore important to maximize your time by planning carefully.

Prioritize your tasks and don't bite off more than you can chew. Make sure that you are allowing yourself enough time to really focus on each of your projects and consider them critically.

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Practice critical thinking in your daily life

Do not limit your critical thinking practice to office hours. While being able to think critically is a must if you want to be successful in business, it is also an important life skill in everyday life.

Next time you are choosing a book to read or watching the news, ask yourself what you want to gain from the book, or why that newsreader is emphasizing a particular story.

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Keep a thought journal

Try to keep a record of difficult situations that arise and how you handle them. Writing down your thoughts on such situations will help you to reflect better on your own actions.

It may not be easy at first, but laying bare your reactions to a difficult situation will help you to identify and eliminate destructive behaviors and therefore solve problems more efficiently.

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Check your ego

Having a big head can inhibit critical thinking since it makes it difficult to be objective when assessing a situation. However, being too altruistic doesn't help either.

Try to assign the same level of importance to both your needs and the needs of others. When analyzing a situation, try to focus on people's motivations; why do they want a certain outcome?

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Practice active listening

Active listening involves truly paying attention while someone else is talking, and not letting your eyes glaze over and your mind run off elsewhere.

Not only is it rude not to listen properly when someone is presenting, but you will miss important information and/or ideas that should be submitted to your own mental analysis.

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Evaluate existing evidence

If you have a business problem to solve, the likelihood is that someone before you has solved a very similar if not identical issue. Make the most of past learnings to help you in the present.

Ask yourself whether you have encountered the issue before and, if not, speak to others. Use all the information available to you to find a successful solution.

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Engage a mentor

Like many other things in life, critical thinking can be taught. If the tips in this gallery aren't enough, it may be an idea to find a mentor who can help you on your way to becoming a critical thinking expert.

A mentor may be able to frame critical thinking in such a way that it becomes more accessible and natural to you, and they may have resources for you to practice with.

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Participate in team-building activities

Many team-building activities put on by companies have the aim of improving the critical thinking skills of employees.

Try not to let the thought of your next team-building session fill you with dread. Instead, see it as an opportunity to hone those critical thinking skills and give you a competitive advantage.

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Take on a leadership role

If you're feeling confident, why not throw yourself in the deep end and volunteer to lead a project? Leaders are required to constantly think critically, meaning you'll have loads of practice.

And as we all know, practice makes perfect. So next time your boss asks for a volunteer to head a new initiative, why not take the plunge?

Sources: (Indeed) (Small Businessify)

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