- July 14, 2014
July 14, 2014 - Edgewater Fullscope updates EDGE software to run on Microsoft Dynamics AX 2012 enterprise resource planning (ERP).
Updates 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).