Computerized System Validation for Analytical Laboratory Equipments

In addition to Computer System Validations (CSV) studies for all laboratory systems, URS, VP, DQ, CS, IQ / OQ and PQ, VR studies are also among our services. The prepared documents cover documentation and applications created with the FMEA risk-based approach within the equipment life cycle. Data integrity, audit trail, backup, recovery, restoration applications are among our services. The applications are carried out by QVAC personnel in accordance with quality systems. XRD, UV, NIR, AAS, DSC, PSD, TA, Microscope, RAMAN, Morphology, Refractometer, Denstymeter, Karl Fischer, ICPMS used in Raw Material, Microbiology and Finished product laboratories. Acceptance and validation studies are carried out in accordance with GxP and FDA 21 CFR Part 11 requirements for systems such as Ciscosimeters, Rheometers, Dissolution, FTIR, Tablet Testers, Scales, Autoclaves, Particle Measurement Systems, Ph Meters, LAF Cabinets, Tractors and Sterilizers. Basis Regulations; cGLP, GMP, PIC / S 21 CFR Part 11, Eudralex Annex 11, GAMP5. Prepared documents; URS, VP, HLRA, FRA, FS, DQ, IQ, OQ, PQ, TM, VR.