SIGMA Pharmaceuticals: First Australian Pharmaceutical Group To Deploy A Paperless MES System
Elan Software Systems, a leading provider of Manufacturing Execution System (MES) software solutions, announced recently that Sigma Pharmaceuticals Limited, a leading Australian pharmaceutical manufacturer, has successfully implemented Elan Software's XFP-MES solutions. The implementation of XFP-MES solutions at the Sigma Pharmaceuticals Dandenong site is the first application of a commercially available MES in the Australian Pharmaceutical market.
The implementation of XFP-EBR by Elan Software includes control of the dispensing, manufacturing and clean-in process (CIP) systems using electronic batch record (eBR). The eBRs are essentially an electronic copy of the standard paper-based batch records that most pharmaceuticals manufacturers use to control their manufacturing process. The advantages of eBR include better traceability through the use of electronic signatures, security and bar-coding, improved repeatability due to stricter control of key process parameters, and simpler review, cross-referencing and storage of batch information.
"The Sigma Pharmaceuticals implementation was successfully managed by Dickinson Autocon, our certified system integrator for Australia." said JP Amadio, managing Director for Elan Software. "We congratulate Dickinson for the project management. The implementation went smooth and Sigma was able to gain many production benefits".
"The implementation of Elan Software System's EBR system, tightly integrated with Sigma's ERP and automation layers, has demonstrated true MES, replacing cumbersome paper based-traceability with electronic work instructions." said Ken Maxwell, Project Director at Dickinson Autocon Systems. "This allows a common validated record of all manufacturing steps with genealogy tracking enabling Sigma to achieve the highest regulatory compliance and to drastically improve batch release times."
ABOUT ELAN SOFTWARE SYSTEMS
Elan Software Systems is a leading provider of Manufacturing Execution System (MES) dedicated to the Life Science industry.
For over 20 years, Elan Software has been providing regulated industries with advanced MES solutions to improve production efficiency and effectiveness. The XFP Suite from Elan Software provides production visibility and control throughout the enterprise by optimizing the entire production cycle from raw material delivery to end product shipment in compliance with 21CFR part 11 and ISA 88/95. The XFP suite promotes paperless manufacturing and provides life science manufacturers with advanced modules for warehousing, weighing and dispensing, work instructions and electronic batch record.
Seven (7) of the top ten (10) health care companies have trusted Elan's MES software. Elan customers include Abbott, AstraZeneca, Baxter, Famar, Fareva, Ipsen, Genitope Corporation, Merck, Sanofi-Aventis, Takeda and UCB.
Elan Software is headquartered in Toulouse, France and Princeton, NJ USA. For more information, visit www.elansoftware.com
SOURCE: Elan Software Systems