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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, 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

 

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.

 

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