I wonder if someone can give me hints for how an "audit trail report" of an ERP (Electronic Resource Planning) system should look like to fulfill the requirements of FDA Quality System audits of medical device manufacturers? /QUOTE]
this has been outlined in the recently published Q&A on
Data Integrity and Compliance With Drug CGMP Questions and Answers Guidance for Industry
I am wondering which regulatory requirement spawns the need for a regular audit trail report? My memory (and cursory re-examination) of 21CFR Part 11 doesn't show that to be the case.
While awaiting your response on the source../QUOTE]
logically :- one would review the physical document in its entirety before clearing/approval. and audit trail of an record represents 'entirity'.
in certain (re)presentations, this has been traced to various responsibilities of quality unit or QC unit.
its long list....appended at end of post...here's ref/links.
Pharmaceutical Quality Control Labs (7/93) :- GUIDE TO INSPECTIONS OF PHARMACEUTICAL QUALITY CONTROL LABORATORIES
PART 211CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS
in audit interactions, further scenario of especially for hybrid systems; the electronic data is not only limited to e-systems;
for example, the PLC has an recipe or set points or record/storage of data, however the organization relies on manual entries in the physical/e-records ==> in such instances it is recommended to review the PLC-data along with the physical records.
7. Who should review audit trails? Audit trail review is similar to assessing cross-outs on paper when reviewing data. Personnel responsible for record review under CGMP should review the audit trails that capture changes to data associated with the record as they review the rest of the record (e.g., §§ 211.22(a), 211.101(c) and (d), 211.103, 211.182, 211.186(a), 211.192, 211.194(a)(8), and 212.20(d)). For example, all production and control records, which includes audit trails, must be reviewed and approved by the quality unit (§ 211.192). The regulations provide flexibility to have some activities reviewed by a person directly supervising or checking information (e.g., § 211.188). FDA recommends a quality system approach to implementing oversight and review of CGMP records. 12