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