In this article, you will learn what is an audit trail or document history in the Document Control Management DCM.
The audit trail is a requirement of the 21 CFR part 11 related to the history of the computer-generated, time-stamped document (§ 11.10 (e), (k)(2), and §11.30).
Persons must still comply with all requirements related to documentation of, for example, date (e.g., § 58.130(e)), time, or sequencing of events, as well as any requirements for ensuring that changes to records do not obscure previous entries.
Audit trails can be particularly for the document history and appropriate when users are expected to create, modify, or delete regulated records during normal operation.
The audit trail and document history can be handled either manually or electronically depending on how your company has established document control management.
AUDIT TRAIL DEFINITION
The audit trail must bring a secure, computer-generated, time-stamped electronic record that allows for the reconstruction of the course of events relating to the creation, modification, or deletion of an electronic record. An audit trail is a chronology of the “who, what, when, and why” of a record. Electronic audit trails include those that track creation, modification, or deletion of data (such as processing parameters and results) and those that track actions at the record or system level (such as attempts to access the system or rename or delete a file).
AUDIT TRAIL REVIEW
Audit trails that capture changes to critical data must be reviewed with each record and before final approval of the record. Audit trails subject to regular review should include, but are not limited to, the following:
Audit trails are considered part of the associated records. Personnel responsible for record review under CGMP should review the audit trails that capture changes to critical data associated with the record as they review the rest of the record. Control records, which includes audit trails, must be reviewed and approved by the quality unit (§ 211.192). This is similar to the expectation that cross-outs on paper be assessed when reviewing data.
AUDIT TRAIL – STATUTORY AND REGULATORY REQUIREMENTS
Title 21 CFR Part 11 that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES), as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records (Title 21 CFR Part 11 Section 11.1 (a))
CIQA is a quality and regulatory consultant with 25 years of experience developing products and managing projects in the medical device supply chain, and pharmaceutical industries. His experience includes research, product development, operations management, manufacturing engineering, equipment design, regulatory affairs, and quality assurance. Specific questions about Document Control Management DCM or quality system training can be directed to CIQA at email@example.com.
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Three (3) Options to Create Document Control Management DCM Procedures:
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For more information about Audit Trail, refer to:
QS Regulation and Guidance • Quality System Regulation and Preamble
Inspection Guide – Pages 8, 15, 21, 22 and 23
Guide to Inspections of Quality Systems [Quality System Inspection Technique (QSIT)]