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State-of-the-art paperless manufacturing facility
Over the years, BestSweet has transformed the business from aconfectionary company making basic candies, to a technology-basedmanufacturing company. As of today, 80% of the plant capacity is dedicated toOTC products. OTC products take a different mindset, one that rewardsinnovation, applied technology and discipline.
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"We employ cGMP standards to all of our drug and dietary supplementproducts. All our processes have had to be validated and the documentationbehind these processes has significantly increased." explains HollisCloninger, Vice President of Regulatory & Compliance, BestSweet. "We came toa point that we could not increase our OTC business without adding qualitystaff for paper reviews. We truly believed an eBR system was the rightsolution to our business challenge. XFP from Elan Software was the only eBRpackage we saw that met all regulatory requirements including cGMP Part 11,and these requirements are very unique and critical to our industry."
Reduced costs and faster product deliveries
With the deployment of XFP eBR, BestSweet aims to replace the currentburdensome paper system by electronic batch reviews. The eBRs will record andtrace all steps of the manufacturing process from incoming raw materials topackaging of finished goods. The advantages of eBR include bettertraceability through the use of electronic signatures, security andbar-coding, improved repeatability due to stricter control of key processparameters, simpler and faster review, cross-referencing and storage of batchinformation. Quality staff will have no need to support the paper system,resulting in significant time savings for value added activities.
"Managing complex processes in highly regulated industries like OTC drugmanufacturing is where XFP-MES excels," said Ken Strum, Sales Director atElan Software. "XFP-MES provides not only complete visibility and proceduralcontrol, exact as-built history and traceability but also fast and efficientbatch release BestSweet needs to satisfy its customers."
ABOUT ELAN SOFTWARE SYSTEMS
Elan Software Systems is a leading provider of Manufacturing ExecutionSystem (MES) dedicated to Life Sciences.
For over 20 years, Elan Software has been providing regulated industrieswith advanced MES solutions to improve production efficiency andeffectiveness. The XFP Suite from Elan Software brings manufacturingintelligence throughout the plant. It provides production visibility andcontrol throughout the enterprise by optimizing the production cycle from rawmaterial delivery to end product shipment in compliance with 21CFR part 11and ISA 88/95. The XFP suite promotes paperless manufacturing and provideslife science manufacturers with advanced modules for warehousing, weighingand dispensing, work instructions and electronic batch record.
Seven of the top ten health care companies have trusted Elan's MESsoftware. Elan customers include Abbott, AstraZeneca, Baxter, Famar, Fareva,Genitope Corporation, Ipsen, LFB Merck, sanofi-aventis, Rochas, Takeda andUCB.
For more information: http://www.elansoftware.com
SOURCE Elan Software Systems
