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.

Need Your Input!

We have been researching where and when to hold our next 3-day 62304/FDA training course and we want your feedback!
1) Does the location in the US for a public course matter to you … for example, west coast (e.g., San Francisco area) vs. east coast (e.g., Boston)?
2) What locations do you prefer?
3) Would you prefer just the 3-day FDA/62034 course or to have the option of a full week 3-day course followed by cybersecurity 1-day, and a usability 1-day?
4) What other countries would you want to see our course offered publicly?
5) What are best two months of the year for the course?  What are the least favored (not workable) months?
Please respond by email to

office@softwarecpr.com by Sep 25, 2019 if possible!

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