QUMAS EQMS

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.