Quality Management


Audits are an essential quality tool for verifying compliance, vendor qualifications, good practices (GLP, GMP, GCP) and progress of the product development plan. In addition, they are often the first step to developing an action plan in areas where "continuous improvement" or deficiencies are already known to exist.

Onorach™ provides a wide scope of different audits covering all stages of the product development plan.  Here are a few of the audit services we offer:
 

  • “For-cause” audits
  • Due Diligence assessments
  • Regulatory inspections (preparation, assistance during, follow-up)
  • GLP compliance audits for non-clinical and toxicological studies
  • GMP compliance audits for pharmaceuticals
  • GMP/QSR audits for medical devices
  • Documentation audit to ensure it is appropriate for a regulatory inspection
  • GCP site audit
  • Investigator site file audit
  • Trial Master File audit
  • Clinical IT and Data Management Audit
  • Vendor qualification audits

 

Quality Assurance Expertise

  • GMP (Good Manufacturing Practice)
  • GLP (Good Laboratory Practice)
  • ISO 13485: QMS for Medical Devices
  • ISO 9001: QMS for all industries

Implementation of QA systems

  • GMP/GLP
  • Preparation of Manufacturing Authorisations
  • QA training
  • ISO 13485/9001

Quality Auditing

  • GxP

Qualified Person

  • Batch certification
  • QP guidance
  • Mentoring QP trainees
  • Medical Devices Expertise
  • Authorised Representative
  • CE marking
  • Change submissions
  • Certificate renewals

Contact us for more information...

 

 

 

 

 

Client Testimonial

Prof. Leiper and her team at Onorach have demonstrated competencies in many areas in both working with the authorities and with the sites as monitors. They impressed us deeply with highly motivated, goal-oriented staff members of lively personality and creativity. It was always a pleasure to cooperate with Onorach Clinical.
A German Client

 

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