Intuitive Medical QMS Software

Facilitate compliance with our agile, secure and cost-effective EQMS powered by Microsoft 365 

Medical-Compliance

Simplify Compliance to Medical Regulations

The need to comply with the international standard ISO 13485 requirements, Medical Device Regulations (MDR) and FDA is challenging for managers in medical device-related industries, healthcare, pharma and life science sectors.

BPAMedical365® is an innovative QMS software for medical quality & compliance management, ready to use in your trusted Microsoft 365 environment, and simplifying compliance to medical regulations. The software includes all solutions, features and benefits of BPAQuality365® plus additional eSignature features and product lifecycle management.

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    Streamline Document Management

    Document management is highly regulated in the medical industry. We have developed specific tools and automated workflows to comply with medical regulations. The BPA eSignature component included in our medical QMS software makes sure only authorized people can sign by using the trusted Microsoft multi-factor authentication system. Automated workflows reduce manual work and streamline complex document management processes.

    Satisfy GxP Guidelines

    Ensure Valid Approvals With ESignatures

    BPA Medical GxP Software

    Ensure Valid Approvals with eSignatures

    The BPA eSignature component provides a simple way for everyone to sign documents or forms based on the robust Microsoft Multi-Factor Authentication system, used by most companies with Microsoft 365. eSignatures are used to make sure the right persons have reviewed and approved important procedures, technical files, or records in compliance with regulations.

    Satisfy GxP Guidelines

    BPA’s medical QMS software and Microsoft Office 365 include solid features to satisfy GxP guidelines and 21 CFR Part 11 requirements for electronic records, like document retention, access control, and audit trail. BPA’s eSignature module gives the extra security required when approving items. Our eSignature module gives the extra security required when approving items.

    Satisfy GxP Guidelines

    Satisfy GxP Guidelines

    Do More With Power Extensions

    BPA Medical GxP Software

    Do More with Power Extensions

    The software provides a robust collaborative platform for the whole organization, leveraging SharePoint and Teams capabilities for instant discussions and video conferencing. Go a step further and meet Industry 4.0 objectives with the Audit Power Apps, Incident and Failure Catalogue Power Apps, productive chatting, AI and prebuilt automated workflows.

    Validate the Software

    Our software validation quick start package simplifies software (SW) validation, and includes document templates, like a SW validation plan, SW validation SOP, requirement specifications, and test case samples for BPAMedical365®. For a turnkey project, our partner offer all needed software validation services.

    Validate The Software

    Validate The Software

    Instantly find out more!


      Engaging

      Engaging

      Boosting user experience & have fun!

      Agile

      Agile

      Enhancing your existing assets & be unique!

      innovative

      Innovative

      Enabling modern technologies & go smart!

      success stories

      100s of Customers and Counting

      OIKEN

      Product : BPAQuality365

      OIKEN is a DSO, a distribution network operator managing electricity, heating, multimedia, water networks as well as everything related to outdoor lighting. With over 550 employees they have been successfully implementing BPA's all-in-one ready-to-use eQMS to achieve ISO 9001, ISO 14001 and Valais Excellence.

      OIKEN Success Story
      Switzerland
      Symbios

      Product : BPAMedical365

      Symbios is a Swiss medical technology company, and the leader in individualized orthopedic implants for hip and knee joint replacement. With over 200 employees worldwide they have been successfully audited by four different notified bodies.

      Symbios Success Story
      Switzerland
      Groupe-E

      Product : BPAQuality365

      Groupe-E is a manufacturer, producer and distributor of electrical energy, as well as a producer of services and goods linked to the energy transition. The company has 2,600 employees, spread over around ten sites across Switzerland...

      Groupe-E Success Story
      Switzerland
      Zuellig Pharma

      Product : BPA Quality

      We have reduced the workload of Operations and Quality by automating flows. The eQMS deployment of all our 16 markets was made easy with BPA tools. With BPA migration assistant, copying the BPA settings from one site to another was...

      Zuellig Pharma Success Story
      USA
      Imspex Medical

      Product : BPA Quality

      The key result from this partnership with BPA is that Imspex successfully achieved ISO 13485 certification in the span of nine months from signing the contract to being audited in...

      Imspex Medical Success Story
      UK

      Microsoft 365 is the Right Technology For Your QMS

      Trust

      Trust

      M365 is trusted by enterprises worldwide.

      security

      Security

      M365 provides the best security for your QMS data.

      Lower Cost

      Lower Cost

      Lower cost in using acquired M365 tools for your QMS

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