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

Client Testimonial

Jan provided excellent monitoring and site management activities for a large, retrospective cancer diagnostic trial in Europe. She is a quick learner, pays excellent attention to detail and is a pleasure to work with. A truly well experienced clinical research professional. Top qualities: Personable, High Integrity, Creative

Joe Bigley, VP of Clinical Affairs at MDxHealth