3-Phased Approach
Brighton uses a three Phased Approach for Documentation Simplification and System Integration
  1. Pre-Assessment Review (PAR) -- Definition of opportunity, Readiness and Scope
    • Time Required: 2-3 days
  2. Proof of Concepts -- Initial Redesign, Documentation Guidelines, Pilot Testing, Change Control and Implementation
    • Time Required: 8-13 weeks
  3. Redesign & Harmonization – Redesign and harmonize remaining documents, Pilot Testing, Change Control and Implementation
    • Time Required: 13-16 weeks
The Benefits
See results following a thoroughly assessing and challenging of the current documentation -- then simplifying and eliminating all unnecessary, superfluous and redundant content that was not required for process control or cGMP reasons.
Reductions
Documents 10 - 25%
Pages 30 - 50%
Entries 30 - 60%
Compliance Documentation Consulting, Systems Comsulting
Compliance Documentation Consulting, Systems Comsulting