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The documentation templates presented in the Validation Toolkit will include:

    • Design History Files
    • Risk Management Plan
    • CSV policies and procedures
    • Functional Requirements
    • Operational Qualification (OQ) test traceability
    • System operational SOPs
    • Performance Qualification
    • Validation Report
    • Change Control
    • FDA

Full-Cycle Validation Consulting Services

Validation-Compliance offers validation consulting service support designed for

companies that do not have significant experience with the validation

process, FDA validation documentation expectations, and the rigors of OQ

and PQ testing. It will also be applicable to the experienced customer who

does not have the time or manpower available to complete documentation,

SOPs, PQ test protocols and executing PQ testing in a thorough and timely 

manner. Services include developing:

    • Corporate policies and procedures for Part 11 validation compliance
    • User requirements specifications (URS) and Functional Requirement         
    • Specifications (FRS)
    • Traceability between specifications and testing protocols  
    • Supplier evaluation, assessment tools and audit checklist readiness
    • Ongoing quality and project plan management
    • SOP development and implementation, together with training for
    • good system implementation
    • IQ/OQ/PQ process
    • Final validation reporting and approval
    • Maintenance and follow-on services

Our Validation Services Team can author all documentation

required for successful validation, consistent with FDA industry standard

methods, and according to the customer's computer systems validation

policies and procedures. If you do not have corporate policies and

procedures in-place, Validation-Compliance can help write those as well.

Validation-Compliance | info@validation-compliance.co.uk