Source: https://www.validation-online.net/part-11-update.html
Timestamp: 2018-10-19 06:30:42
Document Index: 232021793

Matched Legal Cases: ['art-11', 'ART-11', 'art 11', 'art-11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'ART 11']

part-11-update
PART-11-UPDATE.
Part 11 Update rationale.
Extract From http://www.fda.gov/cder/guidance/5667fnl.htm (no longer active link)
We are now re-examining part-11-update, and we anticipate initiating rule making to revise provisions of that regulation. To avoid unnecessary resource expenditures to comply with part 11 requirements, we are issuing this guidance to describe how we intend to exercise enforcement discretion with regard to certain part 11 requirements during the re-examination of part 11. As mentioned previously, part 11 remains in effect during this re-examination period.
Overall Approach to Part 11 Review.
· We will enforce all predicate rule requirements, including predicate rule record and record keeping requirements.
21 PART 11 UPDATE.