FDA Final Part 11 Scope and Application Guidance

FDA CDER issued a final guidance for Part 11 as part of its redirection effort for electronic records and signatures expectation. This is available at the link provided. This guidance is generally consistent with the earlier draft guidance. It also states explicitly that FDA is planning to revise the regulation itself and it explicitly states word processors used to generate SOPs do not require validation.

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.

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