Enterprise Regulatory Compliance Services

Version 2

    Ensuring your systems are qualified for use in regulated environments is vital to the ongoing success of your lab. With more than 20 years of experience in regulatory compliance and 130,000+ successful qualifications, you can trust Agilent CrossLab to help you reduce your regulatory risk. Our qualification processes are fully automated, compatible with most chromatography data systems and independent from equipment manufacturers, helping you to:

    • Save time by concurrently qualifying multiple systems using an automated qualification approach that provides standardized qualification reports ready for electronic or paper review and approval.
    • Reduce risk by choosing setpoints and limits for qualification to your SOP requirements and harmonizing your qualification testing with a universal protocol that eliminates many of the inconsistencies across multiple OEM protocols.
    • Comply with confidence. Agilent CrossLab’s Compliance service helps ensure that scientific instruments and laboratory equipment complies with FDA, EU Annex 11, EU GMP (PIC/S) and 21 CFR Part 211 regulations. Our equipment qualification reports provide all data to support the qualified status of your instruments, regardless of manufacturer.

    Our Regulatory Compliance Services provide multivendor instrument qualification that reduces regulatory risk. Count on Agilent CrossLab to deliver:

    • Solid, reliable automation that never relies just on a spreadsheet, "homemade" software or paper and ink calculation
    • A single, harmonized set of protocols for your instruments, regardless of model or manufacturer
    • The flexibility to configure tests and setpoints to meet your requirements
    • Concurrent system qualifications to reduce out-of-production time by qualifying multiple systems simultaneously
    • Comprehensive compliance, thanks to a full validation of your entire data path from any chromatography data system, providing metadata and results as required by guidelines

     

    More information: Lab Regulatory Compliance Solutions - CrossLab