WASHINGTON, July 14, 2014 (GLOBE NEWSWIRE) -- Microsoft World Partner Conference 2014 -- Edgewater Fullscope, Inc., a wholly-owned subsidiary of Edgewater Technology, Inc. (Nasdaq:EDGW) and leading provider of Microsoft Dynamics AX and CRM solutions to manufacturers, has announced the availability of Fullscope EDGE for AX, the latest industry solution designed to complement existing functionality in Microsoft Dynamics AX 2012 enterprise resource planning (ERP) for chemical, life sciences, pharmaceutical, food, medical device and consumer product goods (CPG) manufacturers.
"As we continued to develop this product, we realized its features were applicable to a broader base of process manufacturers with both regulated and non-regulated production environments," said Russell Smith, senior vice president of Fullscope. "As such, we renamed it from EDGE for Life Sciences & Pharma to EDGE for AX."
Existing features in EDGE for AX that have been updated for Dynamics AX 2012 R3 include Corrective Actions and Preventive Actions (CAPA), enhanced eSignatures, flexible/skip lot sampling plans, approved customer lists and vendor scorecards for quality. To help manufacturers meet specific U.S. Food and Drug Administration (FDA) requirements, new functionalities in EDGE for AX include:
- Master Manufacturing Record (MMR) – Helps manufacturers document how each unique formulation is made, including product specifications, formula/BOM version(s), route(s) and quality requirements (FDA 21 CFR Part 111).
- Device Master Record (DMR) – Provides a compilation of specifications for every unique product confirmation, including production process, packaging and labelling, quality assurance procedures, installation, maintenance and service (FDA 21 CFR Part 820).
- Batch Production Record (BPR), Electronic Batch Record (EBR) or Device History Record (DHR) – Captures and creates complete information up to the point of shipment relating to the production and control of each batch, lot or unit of a regulated product, whether manufactured in bulk or as serialized products or pieces (FDA 21 CFR Part 111.255 and 21 CFR Part 820.184).
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