L'absence de validation d'ERP pointée du doigt par la FDA
Dans cette récente mise en demeure, la FDA met en évidence le rôle joué par l'ERP dans ce laboratoire pharmaceutique et son absence de validation :
In response to this letter, provide your validation plan/protocol for the Microsoft Dynamics system. Include timelines and a schedule of all corrections.
5. Your firm failed to routinely calibrate, inspect, or check according to a written program designed to assure proper performance and to maintain adequate written records of calibration checks and inspections of automatic, mechanical, electronic equipment, or other types of equipment, including computers, used in the manufacture, processing, packing, and holding of a drug product (21 CFR 211.68(a)).
Specifically, your firm failed to establish a validation program for the computer software Microsoft Dynamics used for production, inventory, lot number generation, and laboratory test methods used for raw material, bulk, and finished product test release. Your firm also uses the Microsoft Dynamics program to assist your quality unit for product, document and component control.
