Through the validation of the computer systems we guarantee the efficiency and high quality of their maintenance.
A. We develop the following computer system validation and control activities:
- Preparation of the Global IT Validation Master Plan
- Preparation of the User Requirements Specifications (URS)
- Preparation of the Validation Master Plans (VMP)
- Evaluation of the compliance with 21 CFR part 11
- Analysis and auditing of suppliers
- Risk analysis (RA)
- Traceability matrix
- Configuration plan
- Migration plan
- Preparation and execution of protocols (DQ, IQ, OQ, PQ)
- Preparation and execution of the FAT and SAT tests
- Change control monitoring
- Incidents monitoring and closure
- Revalidations
- Recall plan
