What is an Audit Trail?

What is Audit Trail

 

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 history
Audit Trail – Document History

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:

  • change history of finished product test results,
  • changes to sample run sequences,
  • changes to sample identification, and
  • changes to critical process parameters.
  • ensuring that changes to records do not obscure previous entries.

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))

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application

https://www.fda.gov/media/75414/download

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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 ramon.cayuela@ciqa.net.

A Document Control Management DCM procedure template is available from the CIQA Store.

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Quality procedures templates

Three (3) Options to Create Document Control Management DCM Procedures:

Bronze Option. You Can Create Your Own Quality Procedures, using a Template.

You can download samples of the Document Control Management DCM procedure templates in .pdf format. 

To see the complete list of the most popular quality procedures templates, click here.

In addition, you can request a quotation to buy online a full SOP template document in MS Word format that is completely editable, ready to fill, and adapt to your specific needs.

Silver Option. We Can Bring You a Formal Training on how to implement an Audit Trail in your Document Control Management DCM.

This option is recommended if you want to learn more about how to build robust quality system procedures. One of our expert(s) can provide online step-by-step training to your team (unlimited assistance) on how to build reliable SOPs using our template(s). Also, you can improve your corporate quality procedures and policies by incorporating our template(s) and tools.  It includes a fully editable template from the Bronze option, plus training, exams, and a training certificate for each assistant.  Request a quote now.

Gold Option. We Can Create Customized Quality Procedures.

One of our expert(s) will create and prepare your customized SOPs with the inputs and specific information of your company. It includes a fully editable template from the Bronze option, plus online support in document creation, implementation, and training. Request a quote online.

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REFERENCES:

For more information about Audit Trail, refer to:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application

https://www.fda.gov/media/118202/download

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.40

QS Regulation and Guidance • Quality System Regulation and Preamble

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1

www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/ucm230127.htm

Inspection Guide – Pages 8, 15, 21, 22 and 23

https://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074899.htm

Guide to Inspections of Quality Systems [Quality System Inspection Technique (QSIT)]

www.fda.gov/iceci/inspections/inspectionguides/ucm074883.htm

Ramon Cayuela, MS, BS, Chemical Engineering

Ramon Cayuela, MS, BS, Chemical Engineering

CIQA President and CEO.
I've been working in validation engineering since 1992 with many multinational pharmaceutical companies. I love sharing my passion and knowledge with others. If you have any questions about anything (or just have general questions). I will be more than happy to assist you. You can count on the BEST customer service on CIQA. I go to great lengths to make sure my clients are 100% satisfied with their purchases and check emails/messages consistently throughout the day. You can rest assured that everything being sold here is as-described or your money back. I look forward to working with you!

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