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    C-realize free-to-use Open QMS Quality Management solution

    products-servicesC-realize IT Services SRL
    September 27th 2023

    C-realize offers as an end-to-end Quality Management System software solution that can easily be deployed as stand-alone on-premise QMS system installation or delivered as a hosted application.

    The QMS open source application is a lightweight, scalable and cloud-native open source QMS software package that is highly distinctive in being free to download and use, while also specifically designed and developed as a biopharmaceutical quality system to meet life sciences quality standards such as GXP, FDA Part 11, and EMA Annex 11 .

    Best QMS software

    As part of its mission to help companies in the life science industry (pharma, biotech and medical devices) digitalize and streamline business, IT and quality processes through integration with the cloud while maintaining compliance with regulations, C-realize set out to develop as the best quality management software solution for the life sciences industries, while also providing the best QMS software for manufacturing and small business.

    This is a highly scalable cloud-based QMS system software resource in which companies of all sizes can integrate and share quality management data.

    The program is a response to the increasing need for life science companies to ensure improving patient safety and quality of care and product quality to meet rapidly evolving regulations regarding data integrity and security.

    The cloud native application is based on more than 15 years of experience in computer systems validation (CSV) and regulatory compliance the life science industry on the part of the company and its founder and CEO Hao Wang, who is also C-realize Quality & Compliance lead.

    OpenQMS features and benefits

    OpenQMS also draws on C-realize capabilities in agile software development following controlled software development lifecycle (SDLC) models based on industry best practices and regulatory standards. OpenQMS is based on Microsoft and open source technologies that can easily integrate with Office365, SharePoint, Azure, Dynamics, Power BI and other popular business applications.

    Accordingly, OpenQMS follows a lean approach to software development, adopting the latest cloud-native technologies, while complying with latest industry standards and regulations, particularly FDA Chapter 21, Part 11, and EMA Annex 11, with features such as change management and version control, audit trails, configurable workflows, metadata indexing and e-signature integration.

    Using cloud hosting allows the application to be both agile and lean, making it easier to apply as a whole enterprise quality management software solution, functioning cross organisation regardless of existing platforms and IT infrastructure, also making it highly cost-effective.

    This allows OpenQMS to offer users a series of clear benefits, being a highly accessible way to increase quality, maintain compliance, avoid observations and remarks stemming from regulatory audits, avoid fines or customer complaints, achieve certification and meet industry quality expectations.


    Click on C-realize OpenQMS for further information.
    Click on C-realize OpenQMS portal to access resources.
    Click on OpenQMS Documentation to view user guide.

    C-realize provide help and support for all your Pharma, Biotech and Medical Devices needs in software development, cloud computing services and regulatory compliance advice and solutions, to learn more please book in a Introductory Consultation Session.

    C-realize free-to-use Open QMS Quality Management solution

    Cloud-native architecture allows the C-realize OpenQMS application to offer a full range of quality management software functions and features with minimal IT footprint and requirements.

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