FDA Computer System Inspection Training Chapter 22

In the mid 1990s FDA provided training for inspectors in many aspects of process and computer validation. The link provided is to the section of the training binder related to inspection of computer systems. Note that th is somewhat dated and pre-design control but still contains relevant material to consider when preparing for inspections in this area.

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

Interested in having a conversation?  Email us to arrange a Zoom meeting or call us at +1 781-721-2921.

office@softwarecpr.com

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN), Canada, and Italy.