This content is only available to Premium and higher subscribers. See our Subscribe page for information on subscriptions. The document at the link provided is a SoftwareCPR training aid that provides a partial template with some tips for construction of a handbook/procedure that addresses IT/Network issues regulatory compliance with 21 CFR Part 11 requirements and to support...Read More
CSV Training Course
Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email firstname.lastname@example.org for more info.