Challenge
- All employees stay trained on the applicable documents throughout the separation
- No curricula may be lost during duplication
- GMP requirement documents and training records separate and auditable for both units
Health & Pharma
Separating SOPs and Training Curricula
195 curricula for two business units, two phases with final acceptance
Project
Health & Pharma · Test, Validation & Integration
- Global pharma diagnostics group, reorganization into two business units
- Clearly assign 195 shared curricula and their SOPs
- Preparatory package: around 180 SOPs consolidated to GMP and group requirements
- Two phases, 09/2025 to 05/2026
- Fixed-scope delivery, final acceptance per phase
Solution
- Inventory of the 195 curricula, planning matrix, prioritized work packages
- Duplication and clear assignment of SOPs and curricula per unit
- Compliance plan for the training status, GMP responsibility stays with the client
Result
- Phase 1 accepted: planning matrix, inventory report, recommendations for action
- Phase 2 commissioned immediately afterward, three orders in nine months
- Around 180 SOPs consolidated and moved to the new scope
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