Linked stations respond to pointer and keyboard with a highlight.
Revalidation, Requalification and Incident Management are not linked yet.
Stations by lifecycle phase
The same links as on the map, usable with a keyboard and on a phone. The five phases follow the lifecycle model set out in EU GMP Annex 11 and GAMP 5.
Planning
Define objectives and requirements, clarify responsibilities and control changes from the outset.
Procurement and Supplier Selection
Assess the market and suppliers by risk, and address data integrity before selecting the system.
Implementation and Qualification
Qualification and validation at a risk-based scope: specification, testing, traceability and data integrity to ALCOA+.
Operational
The validated state only holds with upkeep: change control, periodic system review, requalification, incident management and CAPA.
- Change Control Management
- System Review
- Revalidation, Requalification
- Incident Management
- Corrective and Preventive Action (CAPA)
Retirement
Switch off only once the evidence exists: convert data so it stays readable, virtualise systems, keep archives verifiable across the full retention period.