Thank you everyone, for joining the “UPDATE ON GAMP5 SECOND EDITION” webinar on 28 November 2022 despite the holidays in Malaysia. We hope you all enjoyed and learned valuable insights that benefit your company.
In conclusion, here are the key points from the session:
- The regulated company is responsible for compliance and fitness of the system.
- Not everything can be proved by design & test evidence! Supplier assessment of their application and QMS are, therefore, key aspects to build on your CSV approach to ensure system suitability and fitness
- The V-model was commonly misunderstood to be a prescribed approach rather than a basis for the links and activities between regulated companies and their suppliers
- Understanding your business processes and the data needed for each one is crucial. This will help ensure that your process runs smoothly and efficiently.
- GAMP5SE does not prescribe any specific terms for the validation activities, particularly in specification/testing; different suppliers and regulated companies may use their own/other terms
You can access the presentation file here. If you want to refresh your memory.
We are looking forward to seeing you next time!
Factorytalk’s Compliance team are expert in helping regulated industries establish efficient, cost-effective systems that will pass inspection and produce high-quality results. We review current systems and support you through every step to become more efficient, robust, and compliant to stand up to all regulatory challenges with the latest industry regulations governing quality-critical computer systems, including CFR 21 Part 11 and EU GMP Annex 11, Computer Systems Validation (CSV), and Good Practice Update – GAMP Release 2. We can eliminate system validation’s pain using our proven best-practice templates and methodology.