Stilmas can offers a wide range of services related to validation through its organization, specialized in functional areas.
cGMP COMPLIANCE & VALIDATION AREA
Stilmas cGMP Compliance & Validation area organizes and develops validation activities with the “Validation Life-Cycle Approach”, which sees Validation as a traceable and documented evidence for all the activities developed during Life-cycle systems, from the user requirements definition up to the validation maintenance during the routine operation of the system.
Stilmas can organize and implement the following activities:
- Training program of personnel on validation and GMPs related topics
- Validation master plan preparation
- User requirements specification preparation (URS)
- Functional & design specification preparation (FDS)
- Design qualification (EDR: Enhanced Design Review)
- Validation protocols preparation, “Site” tests execution & validation reports preparation for:
- Installation Qualification (IQ);
- Operational Qualification (OQ);
- Performance Qualification (PQ);
- Process Validation (PV).
- Planning & Execution of instruments calibration at final user site
- Computerized control system validation as per GAMP and 21CFR part.11 requirements