It is Regulatory requirement to test the quality of steam periodically. We undertake the job and provide reports which compiles to EN 285/HTM 2010 Guidelines for Sterilizer Validation.
Scope of Work:
Computerized System Validation Services Deliverables
Qualification Doc.: GxP, RA, GAP, CSVP, IQ, OQ, PQ ,(lf required),VSR , Test cases (if required) etc.
Re-Qualification Doc. : RA, Requalification Protocol (Including IQ,OQ,PQ ), Test cases (if required) etc.
Re-Validation Doc. : Performance Verification Protocol (Including IQ,OQ), Test cases (if required)