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 | Fee |
---|---|---|
Starter | Basic review of resource needs and adequacy checklist | Starts at $12/hour |
Standard | Comprehensive resource planning, documentation, and integration with QMS processes | Starts at $12/hour |
Premium | Full resource risk assessment, provision strategy, and improvement roadmap | Custom Quote |
Service | Coverage | Fee |
---|---|---|
Resource Review Workshop | Facilitated session to analyze and plan resource allocation | Starts at $12/hour |
Resource Planning Templates | Pre-built templates for evaluating and tracking resources | $12 per document |
Resource Gap Assessment | Detailed evaluation of current versus required resources | Starts at $12/hour |
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