An audit trail is in place to ensure the ongoing completeness, accuracy, integrity, and security of data and records. It’s also necessary to provide transparency of peoples' actions with the data. This all needs to be available to auditors during an inspection.
Capture the details who, what, when, why of company's data:
Date
Time-stamped
Username
Lesson/Training module
Electronic records and electronic signatures
An audit trail can also help give timeline of a product and the users. Depending on the complexity of a product, users would need to be trained often in order to be compliant. There is so much information and potential changes, it can be overwhelming and hard to keep track. This can be an issue when records or data is missing during an audit inspection and isn't matching with the auditor's system. Centerlizing your user training process and product information would ensure an accurate record, free of gaps and errors. You need to make sure you have a validated system and processes in place to ensure it remains intact secure and readily accessible for audits.
Validated system must include:
Electronic signatures
User Credentials
Security
Source: Audit trail: Medical device consultants: RCA Inc. Regulatory Compliance Associates. (2022, June 16). Retrieved August 1, 2022, from https://www.rcainc.com/published-articles/qa-a-risk-based-approach-to-compliant-audit-trails/