What is an Audit Trail?
The accuracy, integrity and traceability of data is non-negotiable in the pharmaceutical industry. All data created in the process of drug development, manufacturing, testing, and distribution should be dependable and inaccessible. Audit trails are very important here. An audit trail is more than a digital footprint, as it is an axiomatic feature of Good Manufacturing Practices (GMP) and other regulatory mechanisms, including FDA 21 CFR Part 11 and EU Annex 11. It makes certain that any activity pertaining to electronic records is recorded, encrypted, and auditable, and it assists companies in keeping the data intact and in a regulatory manner.
What is an Audit Trail in the Pharmaceutical Industry?
An audit trail in pharma is a secure and automated log that can record all significant changes on electronic records or systems. This encompasses data entry, data modification, data deletions, approvals and even unsuccessful gains of access. Generally audit trail records:
- Who was the one who did it (user ID)?
- What was done (e.g. data change, deletion)
- By the date and time (date and time) that it happened.
- The place or device of doing it.
- Why, where applicable (e.g. comment or reason code)
Audit trials are applicable to systems in laboratory information management (LIMS), manufacturing execution systems (MES), clinical trials, quality management, and other GxP-compliant systems. These records make sure that one can trace all the stages in a product lifecycle.
Why Audit Trails Are Critical for GMP and Data Integrity
Audit trails are not only useful, auditing trails are a regulatory process. U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and MHRA agencies mandate that pharmaceutical companies should use audit trails as part of the data integrity principles.
FDA 21 CFR Part 11, requires that systems containing electronic records shall have secure, computer-generated, time-stamped audit trails. These audit trails should be kept and accessible to auditors and inspectors.
They assist to make sure that ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring and Available) are upheld throughout the data lifecycle. It could not be proved that the data has not been altered either knowingly or not without an efficient audit trail.
Tracking Every Step: How Audit Trails Support Regulatory Compliance
Audit trails aid adherence since they enable full tracking of operations in sensitive systems. In inspections, regulative bodies frequently inspect audit trails to check whether actions have been taken by authorized persons, whether any change has been reasonable, and whether there were any attempts to manipulate data.
As an illustration, a sterile manufacturing facility has a batch record, which is changed, the audit trail must be able to clearly indicate the name of the person who changed the record, the time, and the reason clearly. This will avoid falsification of data and all decisions are recorded in a compliant manner.
To illustrate, in a sterile manufacturing setting, when a batch record is being altered, the audit trail should be in a position to demonstrate clearly who altered it, when, and the reason why. This will avoid falsification of data and all decisions are recorded in a compliant manner.
Best Practices for Implementing Audit Trails in Pharma Systems
The pharmaceutical companies must adhere to the following best practices to be compliant and inspection-ready:
- Turn audit trails on in every GxP system dealing with sensitive data.
- Make sure that audit trails are not modified by users.
- Install user authentication and role based access to define the persons who are allowed to carry out activities.
- Lecture trains employees about the need to document and justify changes.
- Provision of automated notifications or triggers of critical changes or security violations.
- Periodically examine audit trails as a routine or internal audit of the quality of the audit trail.
Having healthy audit trail practices will mitigate the risk of compliance gaps, warning letters or product recalls.
Audit trails play a critical role in the pharmaceutical industry to guarantee data integrity, compliance with regulations, and quality products. At Masuu Global, our expertise lies in providing GxP-compliant digital solutions to the pharmaceutical industry – allowing you to introduce a well-protected audit trail system that can enable you to prepare to pass the inspection, operational excellence, and compliance in the long term.
