Audit

Audits are processes for independent testing of quality management systems and represent an important part of clinical trials and approval processes in the pharmaceutical and medical technology sector. They are required by law (e.g. “ISO 13485” or “21 CFR part 820”) and scheduled in fixed intervals in order to enable a regular assessment of quality processes in companies.

Basically, internal and external audits can be distinguished. Internal audits are usually conducted by in-house employees for the internal evaluation of processes, with the aim of testing, optimizing or validating them. External audits, in contrast, are usually performed by external persons, such as the notified body, to verify compliance with legal requirements (e.g. documentation of process steps, hazard identification, timeliness of risk-benefit ratios). Particularly after vigilance cases (i.e. the notified body decides whether the frequency of on-site visits will be increased) or randomly (at least every 5 years), announced or unannounced inspections will be executed by notified bodies (e.g. surveillance audits).

Internal as well as external audits usually require substantial human resources for the audited company which is often very difficult to reconcile with regular operations. In addition, as the external view of independent experts can significantly enhance audit preparation, CCMD would like to assist in preparing and conducting your audits.

Whether it is the compliance with standard operating procedures (SOP), good clinical practice (GCP) processes, applicable standards or legal requirements that has to be verified – our auditors possess extensive knowledge on applicable standards as well as many years of experience with auditing of management systems and can therefore support the individual needs of your company.

By carrying out and documenting internal audits and by providing you with an audit report, we support you in improving your quality management system and keeping it up-to-date. Hence, you will be optimally prepared for an audit by a notified body.