The Digital Audit Trail Reviewer is responsible for reviewing audit trails and electronic records generated from QC laboratory computerized systems to ensure data integrity, compliance with cGMP and regulatory requirements, and timely investigation of audit trail events. The role supports OOS/OOT investigations, root cause analysis, CAPA implementation, and regulatory inspection readiness.
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- Review audit trail records of QC computerized systems (e.g., Empower, LIMS, HPLC, GC, UV, Dissolution, Malvern, etc.) to verify compliance with Data Integrity requirements.
- Identify, assess, and document audit trail events, ensuring that all activities are attributable, legitimate, and performed in accordance with approved SOPs and cGMP requirements.
- Investigate any discrepancies or unusual audit trail events, determine the root cause, prepare investigation reports, and ensure timely closure of observations.
- Maintain complete and accurate documentation of audit trail reviews in compliance with ALCOA+ principles and 21 CFR Part 11.