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C-realize releases new version of OpenQMS.net cloud-based quality management solution
Cluj, Romania: –Pharma industry IT specialist partner C-realize has released OpenQMS.NET 1.0 as a new major version of its open-source end-to-end Quality Management System solution.
The cloud-based and free-to-download software platform now allows users to sign documents digitally, manage trainings, track deviations and changes, and perform corrective and preventative CAPA actions on products, processes, plant assets, etc.
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 digital integration, C-realize developed OpenQMS.net as an end-to-end Quality Management System software solution optimized for life-sciences applications that can easily be deployed as stand-alone on-premise installation or delivered as a hosted on-cloud SaaS application.
The open-source application is a lightweight, scalable and cloud-native QMS that meets life science companies’ increasing needs to ensure product quality and patient safety, while meeting rapidly evolving regulations regarding data integrity and security. The program allows organizations to integrate and share quality management data while maintaining compliance with regulations and biopharmaceutical quality standards such as GXP, FDA Part 11, and EMA Annex 11.
The cloud native application is based on more than 15 years of experience in computer systems validation (CSV) and regulatory compliance in the life science industry on the part of the company and its founder and CEO Hao Wang, who is also C-realize’s Quality & Compliance lead.
OpenQMS.net features and benefits
OpenQMS.net also draws on C-realize’s capabilities in agile software development following controlled software development lifecycle (SDLC) models based on industry best practices and regulatory standards. OpenQMS.net is based on Microsoft and cloud technologies that can easily integrate with Office365, SharePoint, Azure, Dynamics, Power BI and other popular business applications.
Accordingly, OpenQMS.net follows a lean approach to software development, adopting the latest cloud-native technologies, with features such as change management and version control, segregation of duties and e-signature integration.
Using cloud hosting allows the application to be both agile and lean, making it easier to apply cross organisation regardless of existing platforms and IT infrastructure, also making it highly cost-effective.
Based in Cluj as part of Southeastern Europe’s thriving IT tech cluster, C-realize IT Services is dedicated to enabling life science companies digitalize and streamline their business and quality processes through IT integration with the cloud while maintaining compliance with regulations.
It can construct digital quality management systems that are cloud-native, as well as provide computer systems validation and IT infrastructure qualification for FDA Part11, EMA Annex11, and other regulatory compliance.
The C-realize portfolio of products and services are focused on the specific business and regulatory demands of pharma, biotech and medical device markets, including patient safety, product quality and data integrity.
Its core capabilities are in quality-driven agile and lean software design, development and testing, along with computer systems validation, secure cloud computing services and other regulatory compliance solutions tailored for Pharma, Biotech and Medical Devices. These abilities are harnessed to offer four main service streams.
Over the years since its founding, C-realize has experienced rapid and continuous growth, assisted by its advantages in providing fast response, single point of contact and deep experience in computerized systems validation and compliance for the life science industry.
Click on About C-Realize IT Services to learn more.
Click on C-realize OpenQMS.net for further information.
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.