Fullscope offers EDGE for AX Solutions for life sciences, pharmaceuticals, medical devices, food and beverage, commodity, industrial, specialty, agricultural and chemical manufacturers that need to meet quality standards and stay compliant.
Instrument Calibration—helps track individual test instruments through tags and tracks usage against quality order tests, supports an on-going calibration process, facilitates management of calibration certificates and generates calibration labels.
Production Dispensing—helps manufacturers stay compliant by preventing cross-contamination of materials, enables accurate costing of materials to production based on dispensed usage and provides sign-offs with an electronic signature.
Customer-Specific Certificate of Analysis (COA)—provides a way to group customers for COA-related purposes and set up customer-specific COA requirements.
Quality Associations for Returns and Transfers—automatically generates quality orders from sales returns or from the inventory transfer process, which helps ensure product quality before goods are placed back in inventory.
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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