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Quality is a “set of characteristics that a product or service must have to satisfy the needs and expectations of the customer”. A Quality Management System (QMS) is an integrated approach that enables consistent and efficient delivery of reliable data that may be used by Sponsor, its partners, health authorities and patients to take informed decisions concerning medicinal products.
Synergy’s QMS includes:
Synergy’s QMS enables a more effective and efficient approach to study risks and issues management within ongoing clinical trials.
Quality Risk Management (QRM) is an essential part of Synergy’s effective Quality Management System (QMS). Synergy’s QMS enables a more effective and efficient approach to study risks and issues management.
Being a member of the internationally renowned Research Quality Association (RQA) is a mandatory requirement for the Synergy’s Head of Quality department, which allows the opportunity to stay abreast of the latest developments in quality control and for permanent upgrading of her qualifications and expertise in this field.
Synergy’s Quality department services include the full audit cycle from the development of the audit plan through to audit results & reporting, coordination of the Corrective and Preventive Action (CAPA) plans and follow-up until issue resolution.
Synergy’s independent Quality department is aimed at defining and implementing QRM at Synergy to assure compliance with clients’ and local regulatory requirements as well as applicable GxP standards.
Since Synergy’s team includes internationally certified Quality Management System (QMS) specialists, who have profile experience in the clinical trials industry for over 20 years and are members of international professional associations, we can provide our clients with auditing services for vendors (contract research organizations, sites for conducting early phase and bioequivalence studies, laboratories, logistics companies), as well as other areas involved in the study, which can be conducted both at the study sites and in the offices of organizations involved.
We can organize and conduct both on-site and off-site (remote) audits. Based on the audit results, we develop a comprehensive Corrective and Preventive Action (CAPA) Plan. If necessary, we will perform a re-audit to evaluate the practical implementation of the recommendations received from the results of the initial audit.