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    Ensure quality and safety in all your products

    Unify and centralize your quality management processes, documentation and perform risk assessments with Scilife’s Smart QMS. All on one platform.
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    • Aldevron, Scilife Smart QMS customer | Scilife
    • Biocartis, Scilife Smart QMS customer | Scilife
    • 3p, Scilife Smart QMS customer | Scilife
    • Orasure, Scilife Smart QMS customer | Scilife
    • Coriolis, Scilife Smart QMS customer | Scilife
    • Helius, Scilife Smart QMS customer | Scilife
    • Materialise, Scilife Smart QMS customer | Scilife
    • Midiagnostics, Scilife Smart QMS customer | Scilife
    • Polpharma, Scilife Smart QMS customer | Scilife

    The key components of GMP controlled in one space

    Image that represents the main challenges of not having a GMP-compliant QMS | Scilife

    Challenge

    Overwhelmed by the need to adapt your operating models to meet the dynamic demands of patients, stakeholders and regulatory authorities? 
    
Don’t limit your growth opportunities and empower your innovation. 

    Image that represents the benefits of implementing Scilife GMP-Compliant QMS | Scilife

    Solution

    Scilife provides an all-in-one QMS that ensures a centralized and efficient document management system with 21 CFR Part 11-compliant electronic signatures; training management system with role-based trainings and automated notifications; and an audit management solution linked to CAPAs, Quality Events and Risk Management.

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    Enhance Quality Control

    Reduce product defects and non-conformances, and ensure quality standards.
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    RegulatoryPeace of Mind

    Easily comply with GMP Guidelines, Good Documentation Practices, and Data Integrity.
    Icon that represents how Scilife GMP-Compliant QMS ensure product safety | Scilife

    EnsureProduct Safety

    Guarantee correct handling of raw materials, accurate labeling, and proper packaging and storage.
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    ImproveEfficiency

    Reduce waste and boost productivity, saving costs and increasing profitability.

    Achieve an efficient, centralized and digitized document control system with:


    • Streamlined revision and approval workflows. 
    • 21 CFR Part 11-compliant electronic signatures, as the maintenance of electronic records and audit trail. 
    • Live editing of documents with MS Office tools directly on the platform. No need to download and upload files.
    Image that shows a centralized and digitized document control with Scilife GMP-compliant QMS | Scilife

    Structured and tailored Training Management system that allows you to:


    • Define role-based training according to user functions.
    • Set up automatic notifications upon document approval and reminders for pending training. Forget about chasing your colleagues!
    • Access to detailed training progress by employee, training, role, and more.
    Image that shows a personalized and tailored training management solution with Scilife GMP-compliant QMS | Scilife

    Ensure audit readiness with the Audit Management solution and:


    • Follow a simple and compliant workflow to adhere to all necessary steps in an audit, in line with best practices.
    • Link any relevant information to Events, CAPAs and Risk Management solutions. 
    • Maintain a comprehensive audit trail according to 21 CFR Part 11 standards.
    Image that shows a 21 CFR Part 11-compliant Audit Management Solution with Scilife GMP-compliant QMS | Scilife

    Monitor and manage all your CAPAs efficiently:


    • Create a CAPA plan with all the relevant information and roles.
    • Open a CAPA straight from an event and implement a change management process accordingly without losing information in the process.
    Image that shows an efficient CAPA Management Solution with Scilife GMP-compliant QMS | Scilife

    “Scilife has made our life easier in so many ways. One of the things I like the most is how it integrates different processes. It gives a bigger picture of everything and allows us to keep track of deviations and see opportunities for improvement.”


    Photo of Daniele Scalco, Quality Assurance and Regulatory Affairs Manager at Idevax | Scilife Daniele Scalco,
    Quality Assurance and Regulatory Affairs Manager at Idevax

    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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