SoftwareCPR Comments on Part 11 Glossary

SoftwareCPR submitted comments on the Glossary Guidance to suggest adding a series of definitions to help distinguish various types of electronic records. Different types require different approaches to compliance and validation. Having terms to describe these can help companies evaluating approaches and planning validation. By recognizing these distinctions FDA can also tailor their future guidance and enforcement to allow for these or similar distinctions. The official record of the SoftwareCPR comments is at the link provided.

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.