Turn key capabilities
Developing Complete and Complex Project
With roughly 70 years’ experience and thousands of equipments sold all over the world, many with complete systems supplied to the main Biopharmaceutical and Cosmetic industries for the production of any type of product, Olsa has the competence and the capability to partner its customers in the development, design, manufacturing and validation of complete complex systems for any solid, semisolid and liquid product, including aseptic processing
Olsa can offer a wide range of services related to validation thanks to the full support of its sister Company DOC, specialized in many functional areas
cGMP COMPLIANCE & VALIDATION AREA
MASCO 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 and DOC can together 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