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
or call us toll free at
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.
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