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Validation Online; is part of the AKC group which has over fifty years experience of QA & QC Implementation tasks and ten years of direct internet documentation sales.

Available - COMBINED IQ/OQ/PQ - Protocols.      Available - AUTOCLAVE VALIDATION - protocols.       Available - Video and Audio IQ Demo - protocols.      Want our - MONTHLY NEWSLETTER - Sign here.      Free - VALIDATION DOCUMENTS - Downloads.

Validation Online celebrate the completion of their eleventh year in online sales of cGMP regulatory compliance documentation. Users of our document packages routinely confirm that they - Experience a 70% reduction in the cost of preparing validation plans and protocols - Also - Experience an 80% reduction in the time required to incorporate review comments: - Also - Experience a 95% reduction in the time required to raise supplementary protocols that are routinely required to plug omissions: - Also - Experience a 72% reduction in the time taken in getting their validation tasks to the execution of protocol stage - Also - Experience much greater confidence that their validation task will be completed within time and budget estimates - So keep in mind that. - Using a validation package will ensure your validation task is properly defined, assessed, scoped and subjected to the appropriate intensity of qualification. - - - COLD CHAIN REPORT SHOCKS REGULATORS - - CLOSE TO 50% OF DRUGS ARE DAMAGED PRIOR TO REACHING THE PATIENT - - THROUGH COLD CHAIN COMPLIANCE NEGLECT. Click here to view our validation packages specifically design to keep you Cold Chain Compliant
Table of Contents.

Metal Working Machinery Validation.

Purpose designed to suit Straight manual machine tools such as lathes, mills, moulding, pressing and shaping machines. Incorporates software validation for cnc and numerically controlled machine centers.
VP, URS, VRA, DQ, IQ, OQ, PQ, 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 Validation

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 Validation.

VMP, VP, VRA, DQ, IQ, OQ, PQ, 21 CFR Part11, Quality Water package VMP, VP, URS, VRA, DQ, IQ, OQ, and PQ. Combined IQ/OQ/PQ for Quality Steam Validation (Includes Pitot and Expansion Tubes and various test scripts

 

Software Validation.

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, Validation Manuals, Corporate Quality Manual, Method Statements, SOP for Quality Steam Testing.

 

Validation Implementation Aids.

Vendor Audit & Analysis, Audit check sheets, Gap Analysis, FMEA for Bio-Med, Validation Risk Assessment.

 

Validation Protocol Packages.

Clean Rooms (Zones), General Process Equipment, Laboratory Equipment, HVAC, Utility, Facility, Computer, Water, Building Management Systems, 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 here or call us toll free at 1-877-462-4048.

 

Validation Staff Appraisals.

Multi-choice validation question papers for use in appraising existing staff technical validation knowledge and or streaming candidates for job interviews. Twenty five questions, fifty questions and one hundred questions, all designed to verify personal competency in validation practices and procedures.

 

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  


Bespoke Protocols.

VP, URS, VRA, DQ, IQ, OQ, PQ, and complete (VP � URS � DQ � VRA � IQ � OQ � PQ) validation document packages fully detailed and ready for review, acceptance and execution.

 

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.

 

Spreadsheet Validation Protocols.

Purpose designed to ensure validation of spreadsheets is correctly defined, scoped and executed.
URS, VP and the unique IQ / OQ / PQ combined validation protocol. Available as separate documents or as a validation package.

 

Cold Chain Utilities.

GMP compliant Documents for the validation of Temperature Regulated Utilities such as:- Cabinets, Chambers, Rooms, Zones, Process equipment with temperature controlled compartments, Motor vehicle Vans, Minivans, Trucks with rigid or demountable refrigerated, chilled or cooled trailers. Specifically designed document chain starting with the all important Validation Plan(VP), the Validation Risk Assessment (VRA) and then on to the IQ, OQ,and PQ. Document packages can include all the temperature data loggers you require (just select the right package). Buy and reuse time and time again.