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Bespoke Validation
Protocols
Ready
to use validation protocols authored by our inhouse validation specialists, to
your requirements, VMP, VP, DQ, IQ, OQ, P1Q, P2Q, and various test scripes as
they are required.
Computer.
VMP,
VP, VRA, DQ, IQ, OQ, PQ, 21 CFR Part11 and various test scripts
Equipment
VMP,
VP, VRA, DQ, IQ, OQ, PQ, 21 CFR Part11 and various test scripts
Equipment
Specific Protocols
Autoclave IQ and OQ including all tests scripts and chamber
temperature mappimg.
Facilities.
VMP,
VP, VRA, DQ, IQ, OQ, PQ, 21 CFR Part11 and various test scripts
HVAC.
VMP,
VP, VRA, DQ, IQ, OQ, PQ, 21 CFR Part11 and various test scripts
Utilities.
VMP,
VP, VRA, DQ, IQ, OQ, PQ, 21 CFR Part11 and various test scripts
Procedural.
SOP’s,
Manuals, Method Statements,
Tools.
Vendor
Audit & Analysis, Audit check sheets, Gap Analysis, FMEA for Bio-Med,
Validation Risk Assessment.
Forms.
Calibration Certificates, Change Control,
Agency Reviewed (Pre-used) Equipment
Specific Protocols.
Autoclave (IQ & OQ), KQCL LAL Tester (URS, VP, IQ & OQ), HPLC Method Validation, Sartocheck (DQ & IQ). IQ, OQ, PQ, 21 CFR Part11
and various test scripts
Validation Document
Packages.
Clean
Rooms (Zones), Equipment, HVAC, Utility, Facility, Computer, Water, Bulding
management, Autoclaves, Distributive Control Systems (DCS).
Hardware
Temperature data loggers, humidity data loggers, Quality
Steam Testing Equipment.
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