Jama Connect™ and FDA 21 CFR Part 11

For FDA-regulated organizations, compliance is an important goal, but it is not the only factor when delivering safe and reliable products to market. To achieve compliance, organizations need defined processes for development and production and detailed traceability, from the high-level user needs through to validation and verification. Focus and rigor in the product development lifecycle drives compliance as an outcome. Jama Connect eases the path to compliance so companies can focus on building products right. 

In this datasheet, we’ll take a look at FDA 21 CFR Part 11, and detail how Jama Connect helps FDA-regulated companies comply with:  

  • Subpart A – General Provisions  

  • Subpart B – Electronic Records  

  • Subpart C – Electronic Signatures  

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Jama Connect for Medical Device Development Datasheet
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