$Compliance Training templates for Software$

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

The attached zip file contains 3 training templates. One is for an example software development SOP, one is a companion software development plan, and one is a template for software risk analysis incorporating the concept of predefined categories of Risk Control Effectiveness (RCE). These contain significant explanatory commentary. They are intended as training examples and not as a one size fits all approach. While . . .

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.

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. 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) and Italy.