Audit Checklist: 21 CFR Part 11$

This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions.

SoftwareCPR has prepared an audit checklist for assessing compliance with 21 CFR Part 11 Electronic Records and Electronic Signatures regulation.  The checklist is intended for use by expert assessors knowledgeable in the regulation, its preamble, history, and current enforcement practices.  The checklist was modified March 2003 to reflect issues related to Part 11 redirection issued in Feb 2003.  View the checklist at . . .

Thank you for your interest!  To view our Premium or Standards Navigator content, please click here to select the plan that best fits your needs.

Remote Webmeeting Assessments

SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

Email office@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) and Italy.