Dossier audit

The evaluation of registration documents for completeness and the possibility of using them repeatedly is a very important process, particularly for the continuity of operation of a pharmaceutical company. Regular audits of product documents (by an external unit, KMJ pharma® Sp. z o.o.) allow the company to maintain high quality standards and safety of operation by an early detection of non-compliance in the documentation that may affect patient safety and a financial situation of the company (product recalls, suspension of marketing).

We carry out audits of files in accordance with the highest standards and attention to detail. We put special emphasis on highest risk areas. During an audit, we verify e.g. the correctness and promptness of documentation updates, its (technical) correctness, its completeness vs. applicable requirements and compliance with the documentation approved (e.g. by post-registration changes).

When ordering an audit service for files (whether registered or before registration), you receive a detailed post-audit report, in which we will present information about any gaps or errors in the documentation, along with a suggestion about the method for correcting or filling them.