Computer System Validation Inspection Facilitation
FormaliS provides you support when an inspection from authorities is anticipated, announced and/or conducted.
Activity:
- Preparation and training of teams to get ready for inspection
- Facilitation of inspections by being present while the inspections are carried out
Scope:
- Development sites
- Validation sites
- User sites
- Service providers
- Sponsors
Standards:
- 21 CFR part 11
- Computerized Systems in Clinical Trials
- GAMP standard and applicable regulations
We offer 4 types of services in 4 different areas.
Our Services:
- Auditing
- Inspection Facilitation
- QMS Support
- Training
Our Areas of Expertise:
- Clinical
- Pre-Clinical
- Production
- Computer System Validation