Quality Management System

Document and connect procedures directly to their outcomes

Opvia’s QMS solution is the first operational QMS that connects set procedures directly to their outcomes.

With Opvia, you can manage all aspects of quality in a simple and compliant manner, but also execute procedures and record outcomes from within the platform. This connection between documentation and process allows the iterative improvement of procedures in one collaborative environment with closed loop traceability. 

The no-code design of the platform ensures high levels of configurability but also rapid set up and implementation. No more waiting months for a QMS to be designed and rolled out!

The Opvia QMS has been developed in alignment with ISO 9001, ISO 13485, 21 CFR Part 11 guidelines. The system has full version control, traceable documentation/databases, includes SOPs templates, document management solutions, validation plans and validation summaries. 

Any implementation of the platform follows a process of requirement identification, training management, risk management, vendor management and change management. The platform also includes full workflow assurance on Corrective and Preventative Actions (CAPA) systems. 

Interested in our novel QMS solution? Reach out to the team to find out!

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