Certification Should Be Performed Using A Methodology For Validation Oq, Pq. The Service Provider Must Develop And Coordinate With The Customer The Certification (Validation) Methodology, Which Should Contain The Requirements For Critical Processes Of Equipment And Evaluation Criteria. During The Certification, The Supplier Must Prepare A Report Containing Links To The Certification (Validation) Methodology, The Results Of Validation With The Explanation Of Any Deviations (If Any) And Conclusions, Including Recommendations For Eliminating The Shortcomings. Any Changes In The Certification Method Should Be Justified And Documented. List Of Equipment Of Subject Certification/Validation: 1. Sterilizers, Manufacturer Fedegari (Type Of Validation Oq, Pq). Quantity - 6 Pcs. 2. Cabinets Of Biological Safety (Sbb) Class-Ii, Manufacturer Top-Air. (Type Of Validation Oq, Pq). Quantity - 8 Pcs.
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