Validation Department Leaflet

VALIDATION DEPARTMENT G l o b e T e c h L a b o r a t o r i e s L t d , P O B o x 2 7 4 1 5 , 1 6 4 5 N i c o s i a C y p r u s Tel:+357 22 458260 Fax:+357 22 374535 e-mail:laboratories@globetech-group.com www.globetech-group.com GlobeTech strives to improve quality in manufacturing companies that implement a GMP (Good Manufacturing Practice), Hospitals, Laboratories, etc. by offering professional engineering validation services. Poor validation, result in an inefficient system, which can cause long-term problems and prove costly. Overall, GlobeTech is characterized as a dependable resource, which seeks to be identified not only a "member", but also an "asset" to anyone's project team. We are here to... • validate the air and water system of the facility • validate system balance • validate systems and equipment (DQ,IQ,OQ,PQ) • prepare validation master plan • perform filter integrity tests (HEPA etc.) • verify and document equipment and system performance • perform initial operation, maintenance and performance testing • write validation report and protocols Benefits of validation include… • compliance with international guidelines (GMP, GLP, etc.) • early detection of potential problems • precise tune-up of systems and controls • ensure system functions as designed • proper documentation • healthy and comfortable work environment Functional and Performance Validation The project specifications provide the organisations with a clear description of the extent of validation (and testing) required. The specifications detail responsibilities, validation requirements including what to test, under which conditions to test, reporting, acceptance criteria, acceptable test methods, documentation and scheduling requirements. Validation Reports In accordance with the validation plan, validation reports and protocols are prepared to document specific decisions, actions and their resultant effect on meeting the design intent. Systems are tested, test results are analysed, and performance validated to demonstrate that systems perform according to the design intent under a variety of conditions. The validation report is the primary record document for validating each system and equipment.