Introduction to EBR and Audit Trail
What is an EBR?
An Electronic Batch Record (EBR) replaces traditional paper-based manufacturing documentation with digital records and streamlined workflows. It captures all production-relevant steps, decisions, and approvals in a structured, traceable, and GxP-compliant manner.
Why is the Audit Trail important in the context of EBRs?
The Audit Trail is the backbone of data integrity in EBR systems. It logs every change, access, and decision—complete with timestamps, user IDs, and justifications. This ensures that all information is traceable and tamper-proof.
What does the GAMP 5 Guide say about Audit-Trail Review?
GAMP 5 recommends a risk-based approach to audit-trail reviews. Critical changes—such as those affecting key process parameters or approvals—should be reviewed regularly and systematically. The review functionality must be technically supported and documented.
Challenges in Practice
Why is regular audit-trail review often difficult?
In many systems, audit trails are hard to read, unstructured, or only available as raw data. Filters are missing, context is unclear, and manual evaluation is time-consuming.
What are the requirements in regulated industries?
- Immutability of audit-trail data
- Filtering by date, user, and area
- Mandatory justification for changes
- Export capability for inspections
- Access control for reviewers
How can a modern system address the challenges of audit-trail review?
A well-designed tool should meet the demands of regulated industries—from filtering and contextual access to export capabilities for inspections. It should support reviewers efficiently, maintain clarity, and ensure GxP compliance.
anicomply offers a solution tailored to the needs of pharmaceutical manufacturing. Curious how it works in practice? We’d be happy to show you in a live demo.
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