QEdge

Regulated companies in pharmaceuticals, healthcare, life sciences and consumer goods use QEdge to manage their quality processes electronically. It is an enterprise software platform made by Sarjen Systems, and it brings quality workflows, controlled documents and staff training into one product. The company says the platform is compliant with the US electronic records rule at Part 11 of 21 CFR and with the EU's Annex 11, which govern electronic records and signatures in regulated work.

Quality processes handled digitally

The platform replaces paper-based quality work with digital workflows. Data integrity and compliance are presented as the reasons a regulated company would choose a system built for this purpose.

Document control and approvals

Controlled documents are created, reviewed and approved inside the platform. Each version is held under management, and the vendor offers document control as one of the three core modules of the platform.

Training records for staff

The learning management module keeps training records and delivers training to staff. A company can show which people have been trained on which procedure and when, which is the kind of evidence an audit usually asks for.

Choice of modules and deployment

A company may begin with a single module, two of them or the full set, and extend the setup as its work grows. The platform can be run on the company's own servers, in the cloud or in a mix of the two, and it can be connected to standard enterprise applications.

The company behind the platform

Sarjen has provided information technology solutions to a range of industries since 1998. Its maker is ISO 9001:2015 certified and describes a development process that spans many industry domains. Other products from the same company cover supply chain and sales force and CRM work, the digitisation of clinical research, and drug safety and pharmacovigilance.

Services for regulated industries

The company also offers consulting and implementation services. Its site describes end-to-end support for regulated organisations, with systems designed to be audit-ready from the start and to scale across sites and countries. It states that it works with GxP and global regulatory frameworks and that its licensing can be on-premise, cloud or hybrid, with subscription pricing.