2007 FDA Clinical Trials Computer System Guidance

FDA released its long awaited revision to the Guidance “Computerized Systems Used in Clinical Investigations”. This revision was originally awaiting the revision to the Part 11 regulation which has not yet occurred. The full guidance is at the link provided.

This guidance is less prescriptive and includes a great deal of flexibility in terms of security and audit trails and incorporates the concept of risk in determining what may be sufficient. Some of the items in this guidance are generally applicable to other types of computer systems that are subject to validation and/or Part 11.

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.