NEW ORLEANS, March 18, 2013 (GLOBE NEWSWIRE) -- Convergence 2013 -- Edgewater Fullscope, Inc., a wholly-owned subsidiary of Edgewater Technology, Inc. (Nasdaq:EDGW) ( http://www.edgewater.com), today announced a new series of industry solutions designed to extend existing functionality in Microsoft Dynamics AX 2012 enterprise resource planning (ERP) for chemical, life sciences, pharmaceutical, food and consumer product goods (CPG) manufacturers.
The first product, Fullscope EDGE for Life Sciences & Pharma, will help address core issues that life sciences and pharmaceutical manufacturers face to help them meet the U.S. Food and Drug Administration's (FDA) Quality System Regulation 21 CFR Part 11, cGMP and other various regulatory and international standards such as ISO and Six Sigma. Features will include:
- Corrective Actions & Preventive Actions (CAPA), allows users to automate processes, including capturing an issue, determining the root cause and a corrective or preventative action plan, verifying and validating the action plan and tracking for resolution.
- Electronic device history records (eDHR), helps reduce significant storage requirements and quality issues caused by paper records.
- Electronic device master records (eDMR) and Electronic master batch record (eMBR), enables companies to completely compile and track all records about a medical device or production lot.
- Enhanced eSignatures, includes dual forms of identity and certificate aging to help ensure life sciences and pharmaceutical companies can adhere to the strict interpretation of FDA 21 CFR Part 11.
- Flexible/skip lot sampling plans, enables companies to inspect a fraction of a lot and realize reduced quality and material handling costs, faster material throughput and less redundant and destructive testing.
- Approved customer lists, especially important when dealing with controlled substances and branded products, offers control over what products a given customer can buy and when they can buy them.
- Vendor scorecards/vendor qualification reporting, provides the ability to rate vendors based on their delivery, quality, cost and consistency.
- Validation requirements, includes a toolkit to help life sciences and pharmaceutical companies meet FDA compliance requirements.
"Life sciences and pharmaceutical manufacturers face strict FDA and other compliance requirements and must have regulated procedures and supporting documentation," said John Scandar, senior vice president of Edgewater Fullscope. "Microsoft Dynamics AX has robust functionality to solve most of this industry's business challenges. EDGE for Life Sciences & Pharma provides a cost effective, easy to use solution to meet some of the deeper compliance requirements."
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