Preventive Maintenance
Preventive maintenance is the best way to grant the continuous operation of our Process equipment. Olsa developed a complete program of preventive maintenance activities for its systems, which can be customized according to specific situations. During a Preventive Maintenance visit, a check-list is executed and, where needed, components replacements are performed. Finally, a reliability analysis of the system is performed
Validation
Olsa, thanks to its sister company DOC, can offer a wide range of services related to validation through its organization, specialized in functional areas
cGMP COMPLIANCE & VALIDATION AREA
Olsa 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
Olsa, together with DOC, 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)
- Planning & Execution of instruments calibration at final user site
Computerized control system validation as per GAMP and 21cfr part.11 requirements