Quality Assurance

At Data Management 365 we are quality-oriented. Our Quality Management System has been developed in accordance with the best standards of clinical trials industry and applicable international regulations and guidelines, including GAMP 5; 21 CFR Part 11; ICH GCP E6 R2; CDISC; Good Clinical Data Management Practices. QA is an independent function and is not involved in operations activities.

We strongly believe that quality is the result of the united teamwork. Our policies, standard operation procedures, and working instructions cover the key processes and provide the comprehensive guide to the employees, thus ensuring excellent performance of each and every Company employee and the quality of the Company products and services.

QA Function Activities:

Internal audits Internal audits are conducted in accordance with the annual audit plan to guarantee the high quality of our teamwork and compliance with all applicable regulations, guidelines, and procedures.

Non-conformance monitoring and CAPA initiation Any incident reported is thoroughly investigated, and the corrective and preventive actions are taken to avoid such incidents in future.

External audits hosting and follow up We are proud to say that we’ve hosted and successfully passed numerous audits of our clients, including international CROs and pharmaceuticals companies.

Quality Systems Documents management Our policies, standard operation procedures, and instructions are developed by subject matter experts and undergo the formalized review and approval to make the working processes effective and efficient.

Vendor qualification We have evaluated all our vendors and conduct regular re-assessment of the vendors we work with to ensure the high level of their performance.