Event Recap & Highlights

On June 6, 2024, the ISPE Educational Programs Committee and GAMP Steering Committee hosted one of the first GAMP CoP Forums at the Alkermes office in Waltham, MA. To keep pace with the latest industry standards and guidance on computer systems validation practices, Poxy Clinical’s Alex Ayres attended the half day event to glean insights from both industry and general FDA thinking.

Presentation topics covered upcoming and changing GAMP publications, risk-based approaches to computer system validation, vendor qualifications, and current challenges with AI implementation. Along with the previous topics, one of the top billings on the agenda was a panel discussion on the FDA’s perspective on critical thinking and a risk-based methodology for validating computer systems, chaired by Geetanjali Abbi, Stephen Ferrell, Heather Longden, Lorrie Schuessler, Brandi Stockton, & Seneca Toms.

In an everchanging landscape with shifts to decentralized and technology supported trials, it’s important to ensure that sponsor decision-making and strategic planning practices around selection and validation of software remains in cadence with overall industry system validation practices. Below are some highlights from throughout the day.

Key Takeaways from Overview of upcoming GAMP Global publications

• More focus needs to be spent on risks that keep you up at night, not on low value activities or checklists meant for compliance purposes only.
• The goal should always be quality, and compliance will follow.
• In the age of decentralization and high levels of outsourcing, it’s imperative to be able to map out business processes, flow of data, and who has control at each point in the process.
• Risk Matrices and other documents for systems validation should not be point in time documents, but should be continually reviewed throughout the life of the system.

Key Takeaways from Panel Discussion on critical thinking and a risk-based methodology for validating computer systems

• Though hard to sometimes pinpoint critical thinking, in general all impacted parties should be involved, and “common sense” should be used.
• Focus on the full build rather than tearing apart individual components. If a car was an analogy, it’s more important that the car can drive, rather than checking the tire composition.
• The more focus and time spent in the planning stage, the better the time spent in the execution phase of testing.
• The amount of documentation does not necessarily benefit during expectations. What does benefit is being able to answer “Why?” No one size fits all, and companies will always have their processes that suit them best.
• Poxy can help to ensure those risks that keep one up at night are thoroughly tested, while also guiding away from testing/documentation simply for the sake of quantity. This can reduce timelines spent in testing, ensure closure of gaps, and even help during any future inspections as the documentation is clear, concise, and consistent.

1. Regulatory Compliance:
   The FDA’s purpose is to ask questions, and not to provide answers or suggestions.
   • Don’t wait for upcoming guidances to put practices into place. Years may pass between guidances (19 years between the CSV and CSA guidance!), and at the end of the day they are meant for guidance on current thinking, not regulations.
   • Reduce fear around FDA, especially around deviations. Keep it simple, and create a culture of quality where the focus is on process improvement, not fear of failure. The number of deviations don’t matter, but what does is ensuring processes are implemented to reduce/eliminate the deviation occurring in the future.
2. Risk Management:
   • Risk Management is all about having the right SMEs in the room. The clinical team knows the business process, IT knows system architecture, data management knows data integrity, quality knows quality. Without all players, risks may not adequately be able to be defined.
   • Know how mitigations can lower risks and understand that many risks may never be able to be fully eliminated.
3. Training and Development:
   • Train on quality culture and ensure it’s a team effort. Fessing up to a deviation or mistake is always better than attempting to hide or retcon the deviation. “See something, say something”
4. Impact Assessment:
   • Continue to change hearts and minds. As CSV professionals, we need to help drive change to ensure systems built for purpose and not bogged down with low value activities.
5. Feedback for Improvement:
   • It can be challenging with folks that may have years of experience, but it doesn’t mean they know more or follow good practices
   • Don’t pursue quantity, pursue quality.
   • Perfection is unobtainable, and what should instead be displayed throughout the organization is control of processes.
   • Focus on continuous improvement, not punitive actions.

In the wake of the pandemic-driven technology acceleration, prioritizing value-added activities over cumbersome processes that substitute quantity over quality is crucial. Poxy Clinical recognizes this significance and collaborates closely to tailor validation efforts to the specific business context and requirements.

Looking for validation services that implement latest quality standards? Reach out to Poxy Clinical to mitigate critical business risks and ensure better peace of mind.

Author:

Alexander Ayres
UAT Services Delivery Manager, Poxy Clinical