QUMAS EQMS

BIOVIA QUMAS can be used to create, review, process, approve and manage a wide variety of pre-configured quality and enterprise processes relevant for your QMS department such as Deviations, CAPAs, Change Controls, Complaints and Audits.

QUMAS’s data-centric approach allows you to flexibly manage quality content and to access and re-use all quality data, providing comprehensive visibility into Quality.

QUMAS’s interactive quality dashboards provide QMS overview across business areas and quality initiatives. Reports are available for export, email and scheduling.

QUMAS supports the most stringent requirements such as FDA 21 CFR Parts 11; 210; 820; 600, ISO 9000 and 14000 Standards, EU Annex 11 and cGxP Practices.

QUMAS allows QMS departments to exchange information securely, efficiently and compliantly in the cloud.

You can access all quality and compliance capabilities in one user-friendly interface called MyQUMAS that makes it possible to easily collaborate on compliance content, processes and tasks.

With QUMAS EQMS you can create effective CAPA process controls, tracking and acting on CAPAs resulting from  deviations across multiple plants. From initiation to closure, QUMAS captures, records, routes and verifies completion and approvals, all while auditing each step in the CAPA process. The closed-loop approach allows for automated data entry, launching a CAPA form directly from another form, linking to the root cause and updating affected SOPs within the same solution.

With QUMAS EQMS you can log, route, analyze and correctly respond to all deviations in accordance with associated SOPs. You can also attach controlled documents and initiate CAPAs during Root Cause Analysis and gain insight into trends.

With QUMAS EQMS you can simplify and effectively manage your change control process and assess the impact of product and process changes across functions. By automating the change control process of assessing, planning, building, implementing, verifying and terminating a project, QUMAS facilitates compliance with FDA regulations (21 CFR Parts 210, 820, 600) and ISO standards (9000, 1400, etc.). An effectiveness review helps to ensure that the change control met its goal. Change control trend reports provide a comprehensive view of patterns and trends.

QUMAS EQMS allows you to capture, investigate, and track all complaints to resolution. The system helps you to properly evaluate all complaints while automating the completion of required forms and generating management reports. Trend analysis of complaints in one facility can trigger preventive actions in other facilities, helping to ensure that the same issues are not repeated.

With QUMAS EQMS you can make sure that all non–conformances, observations and recommendations are recorded, tracked, updated and resolved in accordance with the time lines expected by the auditor or as required by law. The system supports the auditing of clinical studies for GCP requirements or auditing a supplier for compliance to your corporate quality standard or an internal department in preparation for an ISO 9001 audit. It also allows auditors to plan and execute audits more efficiently.