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

Available - COMBINED IQ/OQ/PQ:     Available - LIMS Protocols and Packages:     Available - DENTAL VALIDATION DOCUMENTATION:     Available - AUTOCLAVE VALIDATION:      Get our - MONTHLY NEWSLETTER:     Free - VALIDATION DOCUMENTS:

Validation Online celebrate the completion of..........Sixty years of .........."Quality Engineering".......... Thirty years of .........."cGMP Compliance"..........Sixteen years of .........."Internet Sales"..........Click here for free download of these documents..........EU Computer Annex 11 Latest..........Pharmaceutical Glossary..........Matrix For Part 11 Justifications..........SOP for Equipment Validation..........Vendor Audit Check List..........Autoclave Temperature Mapping..........Corrective Actions Report..........
Table of Contents.

Metal Working Machinery Validation.

Purpose designed to suit the validation of 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 document templates 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 script templates.
 

Equipment Validation

VMP, VP, VRA, DQ, IQ, OQ, PQ, Combined Equipment IQ/OQ/PQ Protocol, 21 CFR Part11 and various test scripts templates.

 

Medical Device Validation.

Uniquely interactive templates are prefaced with a completion SOP. All test scripts are included and ready to use. Documents are available in a complete package or individually. starting from VMP - VP - URS - VRA - DQ - IQ - OQ - PQ - DMR - DHF - DPH and protocol status Matrix.

 

Facilities.

VMP, VP, VRA, DQ, IQ, OQ, PQ, 21 CFR Part11 interactive templates and various test scripts

 

Networks

VMP, VP, VRA, DQ, IQ, OQ, PQ, Combined Network IQ/OQ/PQ Protocol, 21 CFR Part11 and various test script templates.

 

HVAC.

VMP, VP, VRA, DQ, IQ, OQ, PQ, 21 CFR Part11 and all the appropriate validation test script templates. Building Management System (BMS) and associated protocols and 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 all appropriate validation test script templates. Building Management System (BMS) all protocols.

 

Software Validation.

SOP, VMP, VP, URS, VRA, DQ, IQ, OQ, PQ, Combined IQ / OQ / PQ and the Validation Package containing all documents templates from the SOP to the PQ (nine documents). Each protocol contains all test scripts.

 

Procedural Documents and SOP's.

SOP�s, Validation Manuals complete with an array of protocol and plan fully detailed templates, Corporate Quality Manual, Method Statements, SOP for Quality Steam Testing, SOP Calibration of Instruments and Sensors (Includes Calibration Manager Auditor).

 

Validation Implementation Aids.

Vendor Audit & Analysis interactive templates.  Audit check sheets, Gap Analysis, FMEA for Bio-Med, Validation Risk Assessment templates ready for user review and edit..

 

Validation Packages.

Clean Rooms (Zones), General Process Equipment, templates for Laboratory Equipment, HVAC, Utility, Facility, Computer, Water, Building Management Systems, Autoclaves, Distributive Control Systems (DCS), Enterprise Resource Planning (ERP) systems (Sunshine Act).

 

Hardware.

Temperature data loggers, humidity data loggers, Fully detailed template for 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 Appraisal.

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.

Templates for; 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, fully detailed template fully comleted for your to execute.  (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) templates, KQCL LAL Tester (URS, VP, IQ & OQ), HPLC Method Validation, Sartocheck (DQ & IQ), IQ, OQ, PQ, 21 CFR Part 11, and all the appropriate test scripts templates.

 

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 interactive template for the 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.