Day

October 16, 2000
The Good Automated Manufacturing Practice (GAMP) organization issued a final draft for review of a guidance for achieving Part 11 compliance for Electronic Records;Electronic Signatures. It is available at the link provided or go to www.gamp.org for more information.. GAMP Part11 draft Note: this is not an FDA Guidance. It was written by an industry...
Read More

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.