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    Streamline compliance and become audit-ready at any time

    Keep your documents centralized, adapt to changing regulations, automate your processes, and pass all your audits successfully.
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    Remove audit stress and be prepared at all times

    Image that represents the main challenges of not having an audit management software for a Medical Device | Scilife

    Challenge

    Preparing for  audits in the life sciences can often feel overwhelming and fraught with risks that could end up in fines and product recalls.

    On the other hand, the meticulous nature of internal audits demands significant resources and time, potentially disrupting daily operations. 

    Image that represents the benefits of implementing an audit management software for Medical Device | Scilife

    Solution

    Scilife offers a comprehensive Audit Management Solution that streamlines the management of any audit—supplier, internal, or regulatory.

    It ensures compliance and  complete traceability with detailed audit trails, extensive documentation, and integration with systems like CAPAs and Change Control, effectively reducing the audit burden on your team.

    Icon that represents how to prepare for an audit with an audit management software | Scilife

    Prove your audit-readiness

    Meticulously document processes, manage findings, and protect traceability through the quality management workflow.
    Icon that represents how to adapt to any type of audit with an audit management software | Scilife

    Adapt to any type of audit and stakeholder

    Keep all your team involved, and coordinate tasks while tracking real-time progress, despite the specific requirements.

    Icon that represents how to avoid errors in your documentation with an audit management software | Scilife

    Avoid errors in your documentation

    Ensure a clear and detailed audit trail with version control functionality, and meet 21 CFR Part 11 and Annex 11 standards.

    Comprehensive audit management:


    • Handle all types of audits effortlessly: supplier, internal, outgoing, and incoming audits.
    • Ease the overall audit process whether it comes from regulatory agencies, customers, or suppliers.
    Screenshot of Scilife Audit Management software | Scilife

    Seamless integration with all your quality processes:


    • Link your audit’s information with other functionalities such as Events, CAPAs, and Change Control.
    • Manage audit findings, non-conformities, and corrective actions easily on the same platform. 
    Screenshot of the quality processes integration with Scilife Audit Management software | Scilife

    Simplify supplier qualifications: 


    • Oversee supplier qualifications in a separate workflow and decide if an audit is required.
    • Maintain compliance with regulatory requirements while efficiently managing supplier relationships. 
    Screenshot of the supplier qualification tool of Scilife Audit Management software | Scilife

    “Doing an audit with Scilife at your fingertips was amazing! Being able to pull up documents at a moment's notice and show them on the screen, showing them batch records and training records and how they are all linked. I think the auditors were just blown away at how easily we could navigate everything. They were just so impressed that it was so transparent! It was beautiful!”


    Keryn Davies Keryn Davies,
    Quality Manager at Helius

    comillas
    Illustration that represents how Scilife smart QMS can help you improve your quality processes

    Turn quality into your brightest asset with Scilife

    When we embrace quality, brilliant things happen!

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