“Audit trail” (also known as audit log) management in the pharmaceutical industry has become an integral part of the quality system because of the current international regulatory demand associated with a pharmaceutical product. Regulators, industry, and standards-setting organizations have recognized the significance of an audit trail, as it is associated with data integrity problems. Industries need to rely more on a risk-based approach to the review of audit trails and establish more nimble and flexible standards to complement these efforts. Pharmaceutical audits by governing bodies issued warning letters to many companies, and they have recognized that quality needs to be built into systems and processes throughout the lifecycle of the product. The audit trails feature is a key source and helps manufacturers to minimize the risk, to maintain the reliability, and security of electronic data to recover lost data. The review study shares some insight into the anatomy of an audit trail, what are its benefits, its types, features, regulatory guidance that are associated with various regulatory agencies, the review of an audit trail, and how to best comply with the audit trail. This article reiterates an interpretation that an audit trail feature plays a vital role to assure compliance.
Cite this article:
Amit Saxena. Audit Trail in Pharma: A Review. Asian Journal of Pharmaceutical Research 2022; 12(4):359-3. doi: 10.52711/2231-5691.2022.00056
Amit Saxena. Audit Trail in Pharma: A Review. Asian Journal of Pharmaceutical Research 2022; 12(4):359-3. doi: 10.52711/2231-5691.2022.00056 Available on: https://asianjpr.com/AbstractView.aspx?PID=2022-12-4-15
1. Mike R. GAMP5 compliance for risk-based computer validation. March 2020; Leveraging. Available on URL: https://www.mastercontrol.com/gxp-lifeline/leveraging-gamp-compliance-for-risk-based-computer-validation.
2. David Jensen. GxP Lifeline, Q and A: A risk-based approach to compliant audit trails. May 2021; Master control. Available on URL:https://www.mastercontrol.com/gxp-lifeline/q-a-a-risk-based-approach-to-compliant-audit-trails.
3. Toscano G. Data Integrity: A Closer Look. NSF International. 2018; White Paper. Available on URL: http://www.nsf.org/newsroom_pdf/pb_data_integrity_closer_look.pdf.
4. Food and Drug Administration (FDA). Warning letters. November 2018; Available on URL: https://www.fda.gov/iceci/enforcementactions/warningletters/default.htm
5. Mrak, E. PDA/FDA Inspection Trends - Parental Drug Association. November 2015; Available on URL: https://www.pda.org/docs/default-source/website-document-library/chapters/presentations/new-england/pda-fda-inspection-trends.pdf
6. Aleksandra C. Data Integrity in Quality Control Laboratory - How to ensure it? 2022; Selvita, Blog. Available on URL:https://selvita.com/blog/data-integrity-in-quality-control-laboratory-how-to-ensure-it.
7. Pharmaceutical Inspection Co-operation Scheme (PIC/S). Good Practices for Data Management and Integrity in Regulated GMP/GDP environments. July 2021.
8. Andy M. Audit trails: Managing the Who, What and When of Business Transactions. August 2017 (updated 4 December 2021); Smartsheet. Available on URL:https://www.smartsheet.com/audit-trails-and-logs
9. Reciprocity. What is an audit trail and what purpose does it serve? Blog. January 2022; Available on URL: https://reciprocity.com/blog/what-is-an-audit-trail-and-what-purpose-does-it-serve.
10. Nuala C and James D. Data Integrity beyond the Lab. ISPE Quality Manufacturing Conference. June 2018; Available on URL:https://ispe.org/pharmaceutical-engineering/january-february-2019/data-integrity-beyond-lab
11. Food and Drug Administration (FDA). Data integrity and compliance with drug CGMP, Question, and Answers, Guidance for industry. December 2018.
12. European Medicines Agency (EMA). Draft Guideline on computer systems and electronic data in clinical trials. June 2021.
13. Robert L. Practical application of data integrity and audit trail review. Lonza informatics. June 2019; Available on URL:https://www.pda.org/docs/default-source/website-document-library/chapters/presentations/pacific-northwest/practical-applications-of-data-integrity-and-audit-trail.pdf
14. Audit trail requirements in electronic GxP systems: A quick guide. The FDA group, Blog. July 2017; Available on https://www.thefdagroup.com/blog/audit-trail-requirements-in-electronic-gxp-systems-a-quick-guide.
15. Shrivastava, R. what is Audit Trail | Audit Trail Review in Pharma Industries | Requirements. LyfnStyle. October 2021; Available on URL:https://www.lyfnstyle.com/what-is-audit-trail-audit-trail-review-in-pharma-industries-requirements.
16. Audit Trail Review: A key Tool to Ensure Data Integrity, eClinical Forum and the Society for Clinical Data Management, October 2020; Available on URL:https://scdm.org/wp-content/uploads/2020/10/eCF_SCDM-ATR-Industry-Position-paper-Final-Editorial-Edits.pdf
17. Chandrasekar P. Audit Trails Review for Data Integrity, Pharmaceutical Updates. October 2021; Available on URL:https://pharmaceuticalupdates.com/2021/10/28/audit-trails-reviews-for-data-integrity.
18. Jeanne M, Audit Forum - Audit Trails - IVT Network Institute of validation technology. November 2021; Available on URL:https://www.ivtnetwork.com/article/audit-forum-audit-trails
19. Chandrasekar P. Requirement of Audit Trails in Pharmaceuticals. Pharmaceutical Updates. May 2020; Available on URL:https://pharmaceuticalupdates.com/2020/05/06/requirement-of-audit-trail-in-pharmaceuticals-and-in-other-industries.
20. Ivan S. Audit Trail and Data Integrity in Pharmaceuticals and Life Sciences, GXP. May 2020; Available on URL:https://www.ivntnetwork.com.
21. What is Data Integrity and ALCOA Plus, Pharma Awareness. January 2019; Available on URL:https://www.pharmawareness.com/what-is-data-integrity-and-alcoa-plus/