Implementing a CFR 21 part 11 software /system helps you to achieve compliance with FDA regulation and also provide you inroads to more clients who can trust your system.
Riskpro's 21 CFR Part 11 services include gap assessment, reviewing and validating your software/systems for compliance and providing you necessary policies and procedures. Towards the end, we provide a compliance letter.
We can carry out a comprehensive compliance audit, either onsite or remotely via phone / email.
If you are looking for 'Validation of the Software in line with FDA 21 CFR Part 11' by a competent and authorised third party agency', then do connect with us at info@riskpro.in
21 CFR Part 11 Consulting
Some of the questions for which we need answers to be able to provide a precise quote.
1. Whether your organization has any compliance framework in place. E.g. QMS/ISO27K/CMMi etc.
2. Whether the software to be assessed for 21 CFR Part 11 is built in-house by you or was is outsourced/bought off-the shelf?
2. Is the software under a current maintenance contract with the vendor?
3. How often do new versions/releases of the software take place?
4. Does the vendor send release notes with each new version/release?
5. A major part of the burden of validation process rests on the software developer/vendor. Is the Software vendor compliant with FDA 21 CFR? If so, can you provide details and specifics of FDA based compliances met by the vendor? The software vendor will need to be engaged for this effort.
