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.