Leading drug manufacturer Eli/Lilly has chosen LASCOM’s Product Lifecycle Management (PLM) suite, Lascom PLM solution to manage engineering drawings of its pharmaceutical plants in Europe.
Eli/Lilly, a famous company in the pharmaceutical world, needed to secure its industrial data relative to the European factories and manage them in accordance to the FDA CFR Part 11 standards of the pharmaceutical sector.
The project, in production since December 2004 on the Sesto (Italy) and Fegersheim (France) plants, consisted in setting up a centralized drawing repository that manages all engineering drawings of the plants. A set of processes around the repository ensure the exchange of drawings and the validation procedures. The electronic signatures of the drawings are made in conformance with FDA CFR Part 11 regulation. With the Lascom PLM AutoCAD connector, the users of in the engineering departments can directly check in/out documents for modifications, and keep their usual working environment.
Thanks to Lascom PLM solution, methods are now homogeneous around all factories which grant better projects. Drawings are also automatically converted in PDF format therefore allowing easy access with a universal viewing method.
Lascom PLM solution impact analysis function feature allows easy access to all drawings that are associated to the modification of one infrastructure or of specific production equipment.
Since the installation at the end of 2004 on the first two production sites, the Lascom PLM application is in production at Speke (England), followed soon of Basingstoke (England) and Alcobendas (Spain).
« We were looking for a solution of management of our engineering plans being able in the long term to support our whole technical documentation. This solution had to integrate documents approval processes with electronic signature, easy to implement and to use, to meet our need of standardization and organization of our working methods.
Thanks to the interaction between data and process, Lascom PLM solution answered our waitings. Moreover, Lascom PLM solution is in total conformity with standard FDA CFR 21 LEAVES 11 (Food and Drugs Administration), essential obligation of the pharmaceutical sector.” M. Laurent Pontasse, Methods, Maintenance and Engineering manager of Fégersheim Manufactory.