Microsoft Dynamics® AX has robust functionality to solve most life sciences and pharmaceutical manufacturing business challenges. EDGE for AX provides a cost effective, easy to use solution to meet some of the deeper compliance requirements.
EDGE for AX helps address core issues that manufacturers face to help 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.
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.
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