In the framework of the EDQM inspection programme for companies who have requested or are holders of a Certificate of Suitability to the European Pharmacopoeia monographs (CEP), inspectors have come across several cases where data had been falsified, in some cases extensively and even systematically. The falsifications consisted of deliberately altering or creating data; be it in the CEP application, in batch records or any other records in order to hide a gap in information between the records and the true state of affairs.