Specific services in the field of project implementation in a regulated environment (pharmaceutical and food industry)
- Consulting by User requirements definition
- Consulting and design of systems
- Preparation of validation plans for the control and monitoring systems
- Implementation and control of validation activities
- Development of control systems based on the ISA S88 standards
- Preparation of standard project documentation for systems in regulated environment based on GAMP 5 recommendations
- Ensuring compliance with 21 CFR Part 11 and EU Annex 11
