E6 Good Clinical Practice

The link provided contains the E6 Good Clinical Practice:Consolidated Guidance from ICH and FDA CDER and CBER. There are several sections addressing data and record handling including electronic records such as Section 5.5.3.

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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