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Strategic Issues
- Regulatory Exposure / Risk
- Too many errors, incidents, discrepancies or deviations requiring investigation
and resolution
- Extended Cycle Times
- Excessive Work-In-Process Inventories that result from processing delays
- Higher Product Cost
- Complex and Excessive Documentation
- High number of changes and revisions and excessive time required for document approval
- Plans to implement an Electronic Documentation Management System (EDMS), Electronic
Batch Record (EBR) and/or Manufacturing Execution System (MES)
- Harmonize Documentation within a site or between plant locations
- Lean initiatives
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Critical Success Factors
- Meet all Regulatory needs
- A Documentation System that is
- Streamlined
- Simplified
- Uniform and Standardized
- ‘Right First Time’ Batch Records
- Clear ‘Ownership’ of Records
- Documentation that is easy to maintain and administer
- Documentation design minimizes errors and omissions
- Minimal Training time is required
- Fewer and less frequent changes
- Faster Product Release Times
- Process Reliability
- Documentation readied for migration to electronic environment
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Brighton - Tool Kit
- Documentation Assessment
- ‘As Is’ Process Maps & Models
- Use & User Review
- Review of Interfaces with other Systems (MRP/LIMS)
- Analysis and Challenges of current Documentation
- “Proof-of Concept” Batch Record redesign
- Definition of Benefits and ROI
- Documentation Redesign
- Identify GMP & process control requirements
- Compare “what's in place” to cGMP requirements
- Recommend appropriate use of technology
- Simplify documentation content, use and interfaces
- Redesign all Master Batch Records
- Use Connect-the-Docs® for
batch record redesign and to issue lot specific Batch Records
- Program Management
Time Compression
Implementation
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Results
- Enhanced Regulatory Compliance
- Pages reduced 30 - 50%
- Document entries reduced 30 - 60%
- Documentation / procedural errors reduced 50 - 80%
- Review cycle time reduced 40 - 70%
- Product release cycle time reduced 30 - 60%
- Manufacturing cycle time reduced 15 - 20%
- Time spent on investigations reduced 20 - 30%
- Document creation/revision time reduced 25 - 40%
- Framework for all processes and products
- Standardized work instructions
- First step when converting to an Electronic Batch Record system (EBR)
- Back-up system for an EBR
- Simplifies implementation of an EBR and conversion of Records for other products
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