Self-Inspection

Our independent department with extensive domestic and overseas QA experience provides audit, quality assurance, and self-inspection services.

In 1999, the CMIC Group established an independent specialized department for the contracted audit business within the company. This independent organization is contracted to work on audit, quality assurance, and self-inspection that require resources to be adjusted according to the number of contracted items. CMIC possesses a wealth of auditing expertise acquired for many years, which is shared within the department to maintain and improve the skills of the personnel who provide the service. Furthermore, we have other organizations and functions that can meet the demands of various customers.

Our Edge in Self-Inspection

  • Our ability to make various proposals and responses have earned us solid trust from many customers based on the experience in contracted self-inspections for post-marketing surveillance and safety management. Work can be handled quickly according to customer needs, and operating based on a low-cost model can be implemented upon request.
  • We continue to improve operational efficiency by setting up efficient self-inspection operations, based on our extensive experience in contracted audits.
  • Internal collaboration among global auditors in Japan and auditors at overseas bases means that self-inspections conducted overseas can be managed and training can be given. Our auditors at overseas bases also support self-inspection in accordance with the overseas regulations.

Services

  • Self-inspection of post-marketing surveillance
  • Self-inspection of safety management
  • Dispatch of personnel responsible for audit
  • Preparation of SOP for self-inspection and checklist
  • Training for self-inspection personnel

Related Services – Quality Management System

We support the construction of an efficient and functional Quality Management System by promoting the experience of QMS operations at CMIC. CMIC has been highly praised by many customers for our Quality Management System. We continuously strive to improve it by our experience in making a large number of operational proposals, and provide a service to construct QMS using this expertise.

  • Proposal of QMS
  • Support for creating quality policy, quality manual, and various SOPs related to QMS
  • Support for creating training materials

Post-Marketing Surveillance

Pharmacovigilance

Consulting Services

Quality Assurance

Asia Clinical Trials