Fourth Shift announces validation services for FDA regulated manufacturers

As part of its Complete Care commitment to pharmaceutical and medical device manufacturers, Fourth Shift Corporation has launched an initiative to help customers comply with Food and Drug Administration requirements. Fourth Shift developed a package of documents and services that will significantly reduce the time and expense associated with the FDA software validation process.

FDA requires that all systems and equipment involved in the manufacturing, packaging, holding, and distribution of pharmaceuticals or medical devices be verified to perform accurately, reliably, and consistently, and that the data supporting these processes is secure. FDA does not certify any software vendor or application, but rather, holds the software user responsible for ensuring that their own system implementations are validated.

"The Fourth Shift ERP system has lot tracking, vendor qualification, and other total quality management capabilities that fall within the scope of FDA regulation. Because validation can be a tedious and costly process, we saw it as an area where we could help our customers improve their efficiency with Fourth Shift," said Paul Kohler, Fourth Shift Solution Architect.

Kohler explained, "Validation consulting firms with no previous exposure to Fourth Shift and/or the customer's unique business environment must spend considerable time developing the information needed to construct the validation documents. This can substantially increase the total cost of the validation project. We eliminated this cost component by leveraging our familiarity with both Fourth Shift software and our customers' operations to build a validation document package that can be tailored to the customer's installation. To our knowledge, no other ERP vendor offers such a package."

The scope of the validation covers all Fourth Shift software functions related to the production and distribution of regulated materials under FDA jurisdiction. The documentation addresses performance validation issues including: qualification testing, quality assurance, software configuration management, training, security, electronic records, and electronic signatures.

Validation consulting services typically provide intensive testing of the system to ensure data integrity. Testing considerations include functional performance, accuracy when data is concurrently entered from multiple terminals, and data integrity in the event of high volume transactions, unexpected computer shutdowns, etc.

"In addition to meeting FDA requirements, our validation package actively promotes total quality management practices, which include reliable lot tracking and documented manufacturing processes that ensure product safety, and continuous process improvement," concluded Kohler. "We believe this model will help our customers realize major savings in time and money in their pursuit of manufacturing excellence."

About Fourth Shift
Fourth Shift Corporation ( http://www.fs.com ) provides e-business solutions to manufacturers through its ERP software suite of products and consulting and technology services. Fourth Shift software is licensed by more than 3,700 customer sites in 60 countries and is translated in more than a dozen languages. Licensees include some of the fastest growing manufacturers and global enterprises from the Global 2500. Fourth Shift is headquartered in Minneapolis with offices throughout the world.

Source: Fourth Shift Corporation

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