Pharmaceutical
In the Pharmaceutical and Chemical industry adherence to regulatory requirements is key. An understanding of GMP and 21 CFR Part 11 are prerequisites for doing business in this sector.
Clients here expect systems to adhere to the requirements of 21 CFR Part 11 and to be validated. A strict process of evaluation is often required from User Requirements Specification (URS) through to a technical design specification (TDS) and design of a validation master plan. A full validation pack is provided with our PEMAC system
Key functionality exist in relation to electronic signature approval within PEMAC.
For more information on 21 CFR Part 11 please click....
Our PEMAC products are used
- Provide Records of Maintenance activities for the FDA
- Control of Asset information including providing auditable records around asset information
- Control of Standard Operating Procedures
- Dealing with Work outside of an agreed timeframe
- Scheduling Calibrations