A pharmaceutical company with over 500 employees managed batch production with chained Excel files and hand-filled batch records. Validations took over two months. Six months of intervention involved production, quality and engineering in parallel.
01 / 04
The situation
- No real-time visibility of the status of the batches in production
- Batch records managed manually, with frequent errors
- Communication between departments via email and chained Excel files
- Validations treated as single blocks: over 2 months for each cycle
- Temporary cross-functional teams, with no stable identity
02 / 04
MES software and digital batch record
- Installation and configuration of the MES with production, engineering and QA
- Automatic management of weighing and batch record drafting
- Interface databases integrated between spreadsheets and MES, with access only for authorised staff
03 / 04
Modular validation process
- Validations broken down into small units that can be carried out and approved quickly
- Automated templates for drafting and approval
- Centralised management with a visual Kanban-based model
04 / 04
Stable cross-functional teams
- Teams with a defined identity and a composition that is stable over time
- Self-coordinating, with a single contact for external interactions
- Each person active on one team at a time
The results
- -50%average project implementation time
- -90%validation time (from 5 days to half a day)
- -94%deviation handling time (from 1 day to 1 hour)