10(e) requires persons who use electronic record systems to maintain an audit trail as one of the procedures to protect the authenticity, integrity, and, when appropriate, the confidentiality of electronic records.
Audit trails should be created incrementally, in chronological order, and in a manner that does not allow new audit trail information to overwrite existing data in violation of [section]11.
Table 1: FDA and EU Audit Trail requirements from 21 CFR 11 and Annex 11 21 CFR 11 EU GMP Annex 11, [section]11.
Item 1: The discussion of the risk-based approach to audit trails in Annex 11 is covered in the Part 11 Scope and Application guidance, (3) so the two regulations are essentially the same.
This category refers to the use of audit trail
data to drive adaptive decision logic within the target ETE.
When you do this upfront preparation correctly, setting up fully functional electronic audit trail
processes will usually only take a few days, perhaps with the help of consultants who designed the proprietary aspects of the audit trail
systems and who have an in-depth understanding of the underlying architecture of business systems.
In addition, both offer audit trails
for determining whether inadvertent or unauthorized changes have occurred.