Quality Management

Quality Management

Audit Support

Safely with our support through the audit

During an audit, gaps and improper answers are often kept concealed. Clumsy answers may often lead the auditor to discover existing nonconformities. With our support, navigating through the audit can be done with ease.

Audit Support

Safely with our support through the audit

During an audit, gaps and improper answers are often kept concealed. Clumsy answers may often lead the auditor to discover existing nonconformities. With our support, navigating through the audit can be done with ease.

Table of contents: Audit Support

Challenges during the audit - you’ve probably been here before

An employee accidentally uncovered a mistake during an audit which led to a discovery of a gap in your QM System?

An audit consists of more than just hard facts and evidence. A cleverly formulated answer can often disguise non-conformities and with the right arguments, some discoveries can be pushed aside.

Usually, a global product portfolio can lead to international audits. Notified Bodies/Authorities have their own procedures, some of them even seem like rituals.

Being prepared for these “rituals” is the key. For an audit by ANVISA or the Korean GMP audit, it is highly recommended to have a native speaker or interpreter present.

Furthermore, beyond these inspections varying through the levels 1-3, the FDA has quite specific requirements which are often difficult to understand if the needed experience is not applicable.

 

Our expert knowledge for your success

We have in-depth, worldwide expertise in the Approval of Medical Devices. I will answer your questions about the MDR and put together a team for your project upon request.

Contact +49 451 808 503 60

qtec as your partner

An audit is not to be underestimated. Our experts have taken part in many different audits of different authorities and Notified Bodies and have been active on both sides of the audit process. We know what requirements ANVISA or the FDA have and how they can best demonstrate compliance in an audit.

We are familiar with:

  • The RCBs that will register with you to be audited
  • How to plan a FDA inspection in a structured way
  • Which employee should take over the communication with the auditor
  • Which experts should be available in the background
  • Who can handle the logistics and thus the communication between the front and back office

We are more than aware of the requirements that the auditors are going to investigate. Because of this, our company is ready to save you and yours from wasting precious time and effort pertaining to the follow-up audit.

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