rantronik was able to support this company in preparing for its upcoming audit. The tasks involved in audit preparation generally comprise an analysis of the status quo and determination of the measures required to achieve the target status. This included the qualitative assessment of processes and approaches derived from this for risk minimisation. In doing so, the focus was not only on meeting the requirements of the audit, but also on ensuring consist product quality and consequently guaranteeing the safety of patients in the long term.

rantronik also supported its client in the creation of storyboards, training catalogues and risk assessments for production equipment. Staff training sessions for audits and the establishment of testing plans and activities for ensuring data integrity also came under the audit preparations.

rantronik supports companies throughout the entire inspection period, which comprises preparations for the inspection, the phase during the audit and any subsequent activities, which may include follow-up meetings, for example.

We will gladly support you in meeting the respective audit requirements, both for audits conducted by the FDA, which are carried out in English as standard, as well as for inspections – now performed by TÜV.

In doing so, our aim is to consistently achieve a successful audit result without observations/findings. In the course of our latest project, thanks to the excellent collaboration with our client as well as network partners, we were able to achieve this in spite of a previous comprehensive Form 483 and a very short preparation phase.

Does your business require support for an audit or assistance with audit preparations?