Quality Assurance

Our consultants can help you manage deviations, the process of organising non-conformance / CAPAs (tracking, coding, and grading), and the review and release of batch records. They are also involved in managing complaints, investigations, and change control. They use their expertise to implement action plans and KPIs. They are also involved in analysis and the Data Integrity Remediation Plan, as well as managing the documentation system. Finally, they can help you train new recruits in quality concepts, deal with the French national agency for drug and medical product safety (ANSM) and health authority inspections, and manage internal audits.

Our teams specialising in project, system, and management can support you in setting up a QMS and with process and quality management, including policies, directives, procedures, instructions, manuals, operating methods, and specifications. They work with you to define job descriptions, training plans, and staff qualifications. They are involved in risk management, risk registers, preparing for internal and external audits, and carrying out your regulatory watch.