ERP Audit Trail audit by FDA? Regular audit trail report template?

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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.


We expect raw laboratory data to be maintained in bound, (not loose or scrap sheets of paper), books or on analytical sheets for which there is accountability, such as prenumbered sheets. For most of those manufacturers which had duplicate sets of records or "raw data", non-numbered loose sheets of paper were employed. Some companies use discs or tapes as raw data and for the storage of data. Such systems have also been accepted provided they have been defined (with raw data identified) and validated.

Carefully examine and evaluate laboratory logs, worksheets and other records containing the raw data such as weighings, dilutions, the condition of instruments, and calculations. Note whether raw data are missing, if records have been rewritten, or if correction fluid has been used to conceal errors. Results should not be changed without explanation. Cross reference the data that has been corrected to authenticate it. Products cannot be "tested into compliance" by arbitrarily labeling out-of-specification lab results as "laboratory errors" without an investigation resulting in scientifically valid criteria.

Test results should not have been transcribed without retention of the original records, nor should test results be recorded selectively. For example, investigations have uncovered the use of loose sheets of paper with subsequent selective transcriptions of good data to analyst worksheets and/or workbooks. Absorbance values and calculations have even been found on desk calendars.

Cut charts with injections missing, deletion of files in direct data entry systems, indirect data entry without verification, and changes to computerized programs to override program features should be carefully examined. These practices raise questions about the overall quality of data.

The firm should have a written explanation when injections, particularly from a series are missing from the official work-sheets or from files and are included among the raw data. Multiple injections recorded should be in consecutive files with consecutive injection times recorded. Expect to see written justification for the deletion of all files.

Determine the adequacy of the firm's procedures to ensure that all valid laboratory data are considered by the firm in their determination of acceptability of components, in-process, finished product, and retained stability samples. Laboratory logs and documents when cross referenced may show that data has been discarded by company officials who decided to release the product without a satisfactory explanation of the results showing the product fails to meet the specifications. Evaluate the justification for disregarding test results that show the product failed to meet specifications.


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
 
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