GAMP 5 is one of the most important validation and computer system assurance guides for the life sciences industry. This year saw the release of GAMP 5 Second Edition. So, what’s new and what’s changed?
The original GAMP 5 was published in 2008, and it went on to become the globally accepted guide for the commissioning, operation, and retirement of computerised systems. Nevertheless, technology has moved on since its release, advancing in areas such as cloud computing, big data, artificial intelligence, and agile software development.
It was time for a refresh, and the Second Edition of GAMP 5 was released in July 2022. Here are some of the notable changes.
Non-Linear Approach to Validation
GAMP 5 Second Edition has removed the assumption of a universal linear approach to software development and, with it, the V-model terminology.
The updated edition instead supports iterative and incremental models, such as agile methodologies for software development and validation. Agile methodologies allow for the continuous delivery of working software developed in iterations.
This change shifts the focus away from the delivery of fixed and prescriptive documents. The focus is now on risk-based records of information that take into consideration modern software lifecycle methodologies.
The linear approach is still applicable for systems that are well established and where requirements are fully known. Commercial off-the-shelf applications are a good example. However, for systems that are higher in complexity and novelty, iterative and incremental models may be more appropriate.
The new Appendix D8 has been included in the GAMP 5 Second Edition to specifically address Agile Software development.
There has been great emphasis recently that validation should be increasingly based on product, data, and process knowledge. Critical thinking has become a hot topic, and it is a key pillar of the FDA’s new Computer Software Assurance draft guidelines, released in September 2022.
GAMP 5 Second Edition and the FDA’s draft guidelines have recognised that the use of rigid tables, overly prescriptive templates, and tick-the-box methods have become commonplace for many companies. This trend impedes critical thinking and can, regrettably, inhibit innovation and the adoption of new technologies.
By facilitating critical thinking, teams can move away from one-size-fits-all, document-heavy validation approaches. Teams can instead apply informed decision-making and good judgement on where and how to scale quality and compliance activities.
Critical thinking gets its own appendix in GAMP 5 Second Edition. This appendix provides many examples of where critical thinking can be applied throughout the system life cycle.
The Use of Software Tools
The replacement of paper with automated processes is transforming the manufacturing and quality landscape. To make this transition, life sciences companies are increasingly using software tools, so much so that a new Software Tools appendix has been added to GAMP 5 Second Edition. Topics such as selection, risk assessment, and life cycle management are all covered in this appendix.
GAMP guidance and the FDA CDRH Case for Quality program strongly encourage the use of software life cycle management tools and automation, which can bring great quality benefits, and have low GxP risk.
– GAMP 5 Second Edition Appendix D9
Software tools generally do not directly support GxP critical processes, plus they can be used anywhere in the business. GAMP 5 Second Edition also points out that software tools are especially prevalent in IT Infrastructure processes.
An important takeaway is that software tools are classed as GAMP Software Category 1 in the second edition of GAMP 5. This is the lowest risk category, meaning that software tools do not require computerised system validation. There should instead be a risk-based approach with the software managed through the application of good IT practices, such as ITIL.
GAMP 5 Second Edition now acknowledges that:
Much information will never exist on paper, or even in the form of a document.
The guidance also states in Appendix M9:
There is no need to create documents simply for the sake of having a document in case of regulatory inspection. If it is not useful for managing the application in a state of control and it is not needed.
Data retained in native software tools offer more robust search capabilities compared to paper records.
One of the main challenges within a highly regulated industry is to continually ensure patient safety and product quality while allowing enough space for innovation growth.
A dogmatic focus on regulatory compliance has caused companies to apply unnecessarily rigid and prescriptive approaches that are disproportionate to the infrastructure of a system and its associated risks.
Recognising that traditional linear or waterfall methodologies cannot be a one-size-fits-all approach for every case allows lifecycle activities to be scaled according to risk, complexity, and novelty. Hence, there is a welcomed introduction of agile approaches in both GAMP 5 Second Edition and the FDA’s Draft Guidance for Computer Software Assurance for Production and Quality System Software.
Additionally, GAMP 5 Second Edition has introduced additional appendices to address new software technologies, such as the blockchain (distributed ledger systems), artificial intelligence, and machine learning. This is to keep pace with the rapidly changing technology landscape that is currently unfolding within the life sciences sector.
GAMP 5 Second Edition is an important and welcome update for the sector. It is an evolutionary change that complements the still relevant key principles of GAMP 5, while also underlining important points within the guidance and introducing new topics that reflect current technology.
Technologies evolve at a rapid pace. The publication of GAMP 5 Second Edition will enable greater innovation and more cost-effective assurance of computer systems.
As a company that is involved in both the development and validation of software systems for life sciences companies, we are excited at SL Controls to embrace the changes outlined in the new GAMP 5 edition.
GAMP 5 Second Edition is a tool that can make achieving compliance easier, but for it to do so, it must keep up with the rapidly changing technology landscape. Perhaps 14 years was too long to wait for this new edition. That said, good things come to those who wait – and this new edition is certainly a good thing!