Improving documentation change control process
In regulated environments, companies are expected to establish procedures for document change control as a way of ensuring product quality and safety.
- Making procedural and workflow changes
- Shifting certain activities upstream
- Setting and communicating expectations on turnaround times
- Training initiators and reviewers on using IT systems
- Better defining roles, responsibilities and expectations for all parties involved.
A pilot study was designed to ensure that the proposed changes were feasible and attainable. This pilot study helped identify some implementation issues, which allowed CRB and the client to alter some procedures. The VSMs were updated to reflect these changes.
Niranjan Kulkarni, director of operations improvement, CRB, a CFE Media content partner. This article originally appeared on CRB’s website.
Original content can be found at www.crbusa.com.