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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

    Meeting Good Manufacturing Practice (GMP) standards is no small feat.

    It requires flawless documentation, strict process controls, and effective risk management to ensure product quality, safety, and consistency across every stage of manufacturing.

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

    Solution

    Our GMP-compliant solution strengthens manufacturing quality and process control from start to finish.

    Centralize documentation in compliance with 21 CFR Part 11, streamline training management, and tailor CAPA workflows—keeping your processes audit-ready and fully aligned with GMP standards.

    Icon that represents how to improve your Quality Control with Scilife GMP-Compliant QMS | Scilife

    Enhance Quality Control

    Reduce product defects and non-conformances, and ensure quality standards.
    Icon that represents how Scilife GMP-Compliant QMS eases the regulatory processes | Scilife

    RegulatoryPeace of Mind

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

    EnsureProduct Safety

    Ensure accurate labeling and proper handling, packaging and storage of raw materials.
    Icon that represents how Scilife GMP-Compliant improves efficiency | Scilife

    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!

    Book a Demo

    EMEA Office
    Louizalaan 489
    1050 Brussels
    Belgium

    US Office
    Scilife Inc.
    228 E 45th St. RM 9E
    New York, NY 10017

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      EMEA Office
      Louizalaan 489
      1050 Brussels
      Belgium

      US Office
      Scilife Inc.
      228 E 45th St. RM 9E
      New York, NY 10017

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