Computer System Validation QMS Support
FormaliS uses its experience to look for answers to your quality management questions.
Activity:
- Support, Consultancy and Assistance in designing Software Development Life Cycles (SDLC)
- Support, Consultancy and Assistance in the design of the validation documentation
- Analysis and/or improvement of existing SDLC and quality systems
- Design of new or alternative quality systems
- Introduction of risk-based approach in validation
- Review of development and validation documents
- Design of new/alternative documentation systems
Scope:
- Computer systems in clinical studies
- Computer systems in lab environment
- Computer systems in production sites
- Development of validation plans
- Execution of software validation programs
Standards:
- 21 CFR part 11
- Computer 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