19 Nov Tissue Manufacturer
Documentation ‘Road Map’ for EBR
Client Situation
- High incidence of Batch Record/SOP related deviations.
- Poorly designed Batch Records and SOPs do not follow actual work flow.
- Cumbersome, redundant data entries in Batch Records and Forms.
- Change Control process burdened by excessive document revisions.
- Difficult to follow, complete and review Batch Records.
- Instructions in SOPs are incorrect, out of sequence, and/or poorly written, and difficult to follow.
- Difficulty migrating existing documentation and work flow to selected EBR application.
Key Issues and Internal Barriers
- Past efforts to redesign and streamline documentation have not produced the expected and necessary results.
- Lack of methodology, understanding of documentation ‘best practices’ and immediacy of redesigning documentation to meet EBR implementation schedule.
- Ensure redesigned Batch Records comply with both 21CFR 820 and 21 CFR 1271 regulatory requirements.
Client Strategic Objectives
- Redesign and simplify Batch Records and SOPs to be clear, definitive, consistent, and easily understood.
- Simplify instructions, reduce data entries, number of documentation related errors, and deviations.
- Correctly define instructions and requirements for accurate execution of process steps in Batch Records for seamless migration to EBR.
- Redesign SOPs to improve instructions and align with process flow.
Key Program Components
- Develop a Guidance Document to establish ground rules and ‘best practices’ for Batch Record redesign and execution.
- Design Batch Records that eliminate redundant data entries and errors, and clear step-by-step work instructions.
- Redesign SOPs that are streamlined, with clear instructions, and follow actual work flow.
- Design documentation and work flow that provides ‘Road Map’ for EBR definition and implementation.
Results and Improvements
- Improved Batch Records that define process requirements/specifications and are aligned with the work flows, providing a clear ‘Road Map’ for EBR implementation.
- Improved and streamlined design of SOPs eliminating redundancy and with clear, active voice instructions, and simplified numbering scheme.
- 45% reduction in data entries.
- 33% page reduction for Batch Records.
As a result of Malcom’s redesign program, the client’s EBR implementation is on schedule.
Primary measurable results:
