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Bespoke Validation Protocols
Ready to use validation protocols authored by our in-house validation specialists, to
your requirements, VMP, VP, DQ, IQ, OQ, P1Q, P2Q, and various test scripts 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.
Implementation Aids.
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 Part 11, 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, Humidity Calibration Kit.
Need Assistance.
Trouble deciding what document you require or need advice on document completion, please do not hesitate to email us for advice.
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