SoftBrands’ FDA Validation Services Stand Out in Marketplace
SoftBrands, a global leader in next-generation enterprise software for midsize businesses in the manufacturing and hospitality sectors, offers complete FDA validation services for its Fourth Shift software, providing professional and affordable full-service validation in a fraction of the industry-standard time.
SoftBrands recently completed a successful validation of Fourth Shift software at Accucaps Industries, Ltd, a full-service contract manufacturer that supplies softgel capsules to a variety of industries, including pharmaceutical and health and nutritional. Accucaps’ director of MRP II implementation Todd Dunn believes the efficiency of the validation process was largely due to SoftBrands’ experienced consultants. “Bringing in people from Fourth Shift that had former knowledge of pharmaceutical companies and a deep understanding of our Fourth Shift system made a huge difference in the success of the project. I was very impressed at how quickly the validation came together, knowing it would have taken us much longer and been significantly less cost-effective to do it ourselves.”
Accucaps’ computer validation specialist John Lopez was also pleased with the effectiveness of the SoftBrands validation process. “SoftBrands did a great job on validating our Fourth Shift 7.20F system. All their documentation was well organized and complete. SoftBrands came prepared with all the right tools to get it done on time and within budget.”
The SoftBrands validation document package for the Fourth Shift system covers all software functions related to the cGMPs under FDA jurisdiction. Validation consulting firms with no previous exposure to Fourth Shift software or a company’s unique business environment must spend considerable time developing the information needed to construct the validation documents, which can substantially increase the total cost of the validation project.
SoftBrands is able to eliminate this cost by leveraging its familiarity with both Fourth Shift software and the life sciences industry, to build a validation document package that is specific to each installation.
SoftBrands is attending the MD&M East (Medical Design and Manufacturing) trade show in New York this week as an exhibitor. The show is the world’s largest event for medical device manufacturers, attracting 1,750 exhibitors and 32,000 buyers. SoftBrands will promote its Fourth Shift software in conjunction with its FDA Validation services.
About Fourth Shift
Fourth Shift is a proven web-based supply chain management solution that delivers measurable operational results. Fourth Shift’s manufacturing solution has broad functionality and extensive capabilities; it facilitates critical business functions including manufacturing, operations, financials, and customer and supplier relationship management. Fourth Shift is a unit of SoftBrands Inc., a global supplier of enterprise application software. Currently focused on the hospitality and manufacturing industries, the company intends to expand both internally and through acquisitions. With more than 5,000 customers in over 60 countries now actively using its Fourth Shift, evolution, Demand Stream, PORTfolio, Medallion and RIOGrand products, SoftBrands has established a worldwide infrastructure for distribution, development and support of enterprise software. The company, headquartered in Minneapolis, Minnesota, has approximately 500 employees with branch offices in Europe, Asia, Australia, the Middle East and Africa. Additional information about SoftBrands is available at www.softbrands.com .
