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.
VMP, URS, VP, VRA, DQ, IQ, OQ, PQ, Combined Computer IQ/OQ/PQ protocol, 21 CFR Part11 and many test script templates.
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.
VMP, VP, VRA, DQ, IQ, OQ, PQ, 21 CFR Part11 interactive templates and various test scripts
VMP, VP, VRA, DQ, IQ, OQ, PQ, Combined Network IQ/OQ/PQ Protocol, 21 CFR Part11 and various test script templates.
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.
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.
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.
SOPs, Corporate Validation Manual complete with an array of protocols and plans all fully detailed. 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..
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).
Temperature data loggers, humidity data loggers, Fully detailed template for Quality Steam Testing Equipment, Humidity Calibration Kit.
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.
VrrP Plans, 4Q Protocols and Packages.
This quite revolutionary two document package is all that is required to fully validate; to cGMP standards, equipment used in a regulated facility. A lot of effort has gone into ensuring that repetitive instructions and actions have been designed out and innovative and intuitive risk-based methodologies have been incorporated. Both documents are prefaced with a methods Standard Operating Practice (SOP) document. These SOP’s lead you through the task of converting these highly detailed templates into your very own company bespoke protocols. The hyperlinks and cross-references within the package are; not only unique, but also highly cost effective and intuitive to use. Each document is preloaded with the test scripts (complete with acceptance criteria). All test and inspection scripts are written in MS word, to facilitate simple editing of text, layout, tables and schematics.
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.
503B approved facilities are required to maintain full compliance with current good manufacturing practices (CGMP), I.E. the ensuing steps for dispensing, mixing or blending, filtration, compression or filling, container closure system (CCS) filling, coating, polishing, device filling, and packaging of a drug product must occur under a strict CGMP systems of controls.
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.