Version Control

Definition

Version control is the management of document and template revisions, such as MBRs, SOPs, and EBR configurations, to ensure that only the current, approved version is available for use, while prior versions are retained and clearly distinguishable for historical reference and audit purposes.

Benefits

Robust, system-enforced version control removes the risk, common in manual or paper environments, of an outdated document version being mistakenly used, since an electronic system can be configured to make only the current approved version accessible for active use.

Use Case

An MBR revision is approved through the change control process. The EBR system automatically retires the previous version from active use for new batches while preserving it, fully intact and clearly labeled, for any historical batch records that reference it.

Frequently Asked Questions (FAQ)

Related Terms

• Master Batch Record (MBR)
• SOP (Standard Operating Procedure)