|
Strategic Issues
- Regulatory Exposure / Risk
- Regulatory compliance
- Too many errors, incidents, discrepancies, or deviations requiring investigation,
resolution and corrective action
- High number of changes and revisions and excessive time required for approvals
- Extended cycle times
- Excessive in-process inventories
- Higher product cost
- Excessive documentation
- Plans to implement an Electronic Document Management System, Product Data Management
System, Device History Record and/or Manufacturing Execution System
- Harmonization of documentation within a site or across sites
- ISO Certification
- 21CFR part 11 compliance issues
- Lean initiatives
|
Critical Success Factors
- A Quality System in place to comply with the Regulations
- A Design History File (DHF) that describes the design history of a finished device.
- Device Master Record (DMR) containing the procedures and specifications for a finished
device.
- Device History Records (DHRs) that meet requirements for Production & Process
control
- An effective Change Control Process with few and infrequent changes required
- Clear ‘Ownership’ of Records
- Documentation that is
- Streamlined
- Simplified
- Uniform and Standardized
- Easy to maintain and administer
- Designed to minimize errors and omissions
- Minimal Training time is required
- Fast Product release times
- Process reliability
|
Brighton - Tool Kit
- Documentation Assessment
- ‘As Is’ Process Maps & Models
- Use & User Review
- Review of Interfaces with other Systems (EDMS/MRP/LIMS)
- Analysis and Challenges of current Documentation
- “Proof-of-Concept” Device History Record redesign
- Definition of Benefits and ROI
- Documentation Redesign
- Identify GMP & process control requirements
- Compare what's in place to requirements
- Recommend appropriate use of technology
- Simplify documentation content and interfaces
- Develop model and format for uniform and standardized DHRs
- Use Connect-The-Docs® for DHR
redesign and to issue lot specific DHRs
- Program Management
- Time Compression
- Implementation
|
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 DHR system
- Back-up system for an electronic DHR system
- Simplifies implementation of an electronic DHR
|