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Spreadsheet Validation Protocols
Purpose designed to ensure validation of spreadsheets.
URS, VP and the unique IQ / OQ / PQ combined validation protocol. Available as separate documents or as a validation package.
Computer.
VMP, VP, VRA, DQ, IQ, OQ, PQ, Combined Computer IQ/OQ/PQ protocol, 21 CFR Part11 and many test scripts
Equipment
VMP, VP, VRA, DQ, IQ, OQ, PQ, Combined Equipment IQ/OQ/PQ Protocol, 21 CFR Part11 and various test scripts
Equipment Specific Protocols
Autoclave IQ and OQ including all tests scripts and chamber
temperature mapping.
Facilities.
VMP,
VP, VRA, DQ, IQ, OQ, PQ, 21 CFR Part11 and various test scripts
Networks
VMP, VP, VRA, DQ, IQ, OQ, PQ, Combined Network IQ/OQ/PQ Protocol, 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, Combined IQ/OQ/PQ for Quality Steam Validation (Includes Pitot and Expansion Tubes and various test scripts
Software.
SOP, VMP, VP, URS, VRA, DQ, IQ, OQ, PQ, Combined IQ / OQ / PQ and the Validation Package containing all documents from the SOP to the PQ (nine documents). Each protocol contains all test scripts.
Procedural.
SOP’s,
Manuals, Method Statements, SOP for Quality Steam Testing.
Implementation Aids.
Vendor
Audit & Analysis, Audit check sheets, Gap Analysis, FMEA for Bio-Med, Validation Risk Assessment.
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.
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.
Forms.
Calibration Certificates, Change Control, Change Note, Change Request Form, Change Request Index, Document Approval Form, Document Circulation Form, Document History, Document Transmittal Form, Full Life Cycle Planning Chart, Master Document Index, Planning Validation Plan (VP), Review Summary, Standard Life Cycle Validation V Chart, (Software), Standard Validation Document Interrelationship V Chart, Test Progress, Sheet, Test Results Sheet, Validation Activities Plan Chart, Validation Planning Schematic
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