Tissue Manufacturer - Malcom Associates
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Tissue Manufacturer


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:

Client Quotes