Questions and Answers Document on Audit Alternatives of Notified Bodies

Recommendation

29-31 March 2023
Heidelberg, Germany

The Validation Manager in the Pharmaceutical Industry

In a previous news you could read about audit alternatives of Notified Bodies in Covid-19 times. The guideline was based on a document of the Medical Device Coordination Group (MDCG). This guideline has now been supplemented by a question and answer document.

In December 2020, the MDCG published a six-page question-and-answer document on alternative audits of Notified Bodies. The main idea of the whole document is that Notified Bodies should provide a risk-based and documented justification when they use alternative audit methods, such as remote audits.

The question-and-answer document also contains some very detailed answers. For example, the question about the necessary technology and how to deal with it in the case of "remote audits" refers to the necessary preparation of such an audit. Comparable to on-site audits, preparation plays a major role, according to the Q&A document. A pre-test is recommended to check the technology and the internet connection in order to avoid unforeseen problems during the audit. It is pointed out that the connection quality and the stability of the internet are essential. In this respect, connections should also be tested in all areas and rooms to be covered by the audit. It is also recommended to have an IT staff member permanently available on site on both sides during the audit. Furthermore, formalised agreements, also regarding data security, are pointed out.

Conclusion: The Q&A document is easy to read and goes into detail in some passages. You can find the document under the designation MCCG 2020-17 on the EU website.