Phase | Key Activities | Core Deliverables |
---|---|---|
Month 1 – Planning | Kick-off, scope definition, project charter |
✓ Implementation Plan ✓ Scope Statement & Team Roles |
Months 1–2 – Design | FSMS drafting, PRP setup, document control systems |
✓ SOPs, PRPs ✓ Controlled Document Framework |
Months 2–3 – Execution | Competency training, system rollout, records logging |
✓ Training Logs ✓ First Cycle Recordkeeping Evidence |
Months 3–6 – Validation | Internal audits, reviews, performance monitoring |
✓ Internal Audit Reports ✓ CAPA Logs ✓ Management Review |
Month 6 – Readiness | Final system check, CB coordination, mock audit |
✓ Pre-Audit Summary ✓ Final CAPA Log ✓ Audit-Day Prep |
Package | Coverage | Investment |
---|---|---|
Starter | Basic communication checklist and notifications | Starts at $12/hour |
Standard | Implement communication plan, track acknowledgments, collect feedback | Starts at $12/hour |
Premium | Full deployment including training sessions, ongoing monitoring, improvement plan | Custom Quote |
Service | Coverage | Fee |
---|---|---|
Policy Awareness Training Workshop | Interactive session to ensure understanding of the quality policy | Starts at $12/hour |
Communication Tracking Templates | Pre-built templates for tracking acknowledgment and comprehension | $12 per document |
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