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Phase 1
Pre-Assessment Review
- High level assessment of current documentation and business processes – Review:
- Completed Batch Records
- Relevant SOPs
- Documentation and Cycle Time Metrics
- Outline program for Assessment and Implementation
- Recommended next steps
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Phase 2-5
Assessment
- More in-depth assessment of documentation and processes with ‘brown paper’
exercise
- Challenge the ‘As-Is’ process
- Develop Guidelines for documentation practices
- Develop ‘Proof of Concept’ batch record for selected product(s)
- Demonstrate Connect-The-Docs®
software using the ‘Proof of Concept’ record
- Develop metrics to measure continuous improvement
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Phase 6
Implementation
- Redesign remaining documentation/processes
- Develop history of changes for change control submission
- Train personnel on use of new system, program concepts, and maintenance of system
- Begin measuring improvement
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