How InstantGMP Software Manufacturing System solves both EU Annex 11 and FDA 21 CFR Part 11
Regulated products are a (intra) world business. The revenue for the entire Pharma Domain alone is almost US $1.5trillion. Given this potential market scope, related services, and the global collaboration that is key to its progress, it’s important to use software tools that are compatible with both the EU and FDA regulations.
The Annex 11 and FDA 21 CFR 11 were both created to enable electronic documentation. The good news is that they are generally harmonious with one another; however, there are differences.
While the FDA code specifies electronic signature requirements for records within systems, the Annex 11 covers the actual quality management of computer systems, ensuring the same product quality and QA as manual systems. This means the software manufacturing system operations and workflows, in addition to the included e-signoffs, must prove compliant.
Another key difference in the regulations is that Annex 11 takes a risk-based approach to quality systems. This includes formal agreements, supplier audits (available on request), inventory, etc., all of which are not specified in 21 CFR Part 11.
How does InstantGMP PRO address these specialized Annex 11 requirements? We’ve designed a risk evaluation work step for our deviation, incident, and customer complaint workflows. Our EQMS contains audit trails and a Vendor Management capability to create and review (together with our EDMS) agreements interactively and to qualify suppliers. In addition, our inventory system connects specified tests and methods to the material approval process while tracking the expiry and retest dates of all receipts in real-time.
InstantGMP PRO can be used with confidence on either side of the Atlantic and many other places as well. Opening the door to health betterment worldwide.
References
“What’s the Difference? FDA 21 CFR Part 11 vs. EU Annex 11 ”, Hal Mannan,
3/2023