C-realize OpenQMS.net: Free and open-source Quality Management System

C-realize has developed OpenQMS.net as a lightweight, scalable and Cloud-native open-source web software application that is free to download and use, unlike most competitors.

OpenQMS.net provides life science companies with an end-to-end Quality Management System (QMS) solution that can easily be deployed as stand-alone onsite QMS system installations or accessed across the enterprise as a web-hosted application.

OpenQMS features

OpenQMS.net was developed to meet the increasing needs of the life sciences and other industries for quality management IT systems that incorporate the features demanded by regulators to safeguard product quality and data integrity across the entire product lifecycle while also respecting regulations e.g. 21 CFR Part 11.

Life sciences companies need a modern QMS application that meets the latest technological standards, complies with current and imminent regulations and is affordable. The ideal QMS application should also be readily scalable to keep up pace with a growing organization and expanding activities.

OpenQMS.net architecture draws on C-realize’s extensive knowledge of computer systems validation (CSV) and regulatory compliance, with founder and CEO Hao Wang, who is also C-realize’s Head of Quality & Compliance, having 20 years of experience in the life science industry.

Accordingly, OpenQMS.net is designed to be lightweight (making minimal storage, processing or platform demands), highly scalable, cloud-native and free to use, without burdensome ongoing license fees.

OpenQMS.net also takes advantage of C-realize’s capabilities in agile software development in following controlled software development lifecycle (SDLC) models according to industry best practices and regulatory standards. Thus, it adopts the latest cloud-native technologies and incorporates features such as change management and version control, and e-signature integration., as demanded by 21 Part 11, and EMA Annex 11 regulations.

Furthermore, OpenQMS.net is based on Microsoft and open-source technologies that can easily integrate with Office365, SharePoint, Azure, Dynamics, Power BI and other popular business applications.

OpenQMS.net benefits

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

This allows OpenQMS.net to offer users a series of clear benefits:

• A highly accessible and low-cost route to increase quality and maintain compliance across the organization
• Inbuilt compliance features to satisfy regulatory audits, avoid fines or customer complaints, accelerate speed to market and meet industry quality expectations
• Easy to use with intuitive user interface
• Readily customizable and easy to integrate with other popular applications
• Highly scalable thanks to architecture and cloud hosting
• Free to download, install and use, with no purchase fees or ongoing license payments

Resources

Click on C-realize OpenQMS for further information.
Click on C-realize OpenQMS portal to access resources.

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.