Manufacturing Quality Management

Manufacturing quality management is characterized by sampling and workflow that are highly structured and optimized according to the requirements of the manufacturing supply chain, process, product, customer base, etc. Emphasis is on efficient, reproducible and rapid processing, effective delivery of results, specification management, advanced integration with other enterprise systems (ERP, Shop Floor Control, Process Control, etc.) and the customer support function, and conformance to manufacturing standards (ISO, GMP, 21CFR, etc.).

BlazeLIMS improves performance in this mission via the following features:

• Numerous highly configurable sample identification fields provide ease of use and reduced training needs for plant operators.
• Multi-sample automatic and manual logging features for ease of use.
• Flexible and easily configured templates and schedules for product/process based sampling/analytical strategies, including interval, calendar, skip lot, by exception and other capabilities.
• Workflow automation features such as autologging, barcoding, auto-approval options, grouping activities and data by process area, etc. to optimize productivity and reduce errors.
• Configurable multiple levels of approval with electronic signature and forced comments for sensitive industries/products.
• Highly flexible and configurable method/testing/calculation capability to support highly varied product/testing mixes.
• Instrument integration via BlazeLink to streamline throughput and reduce errors.
• Numerous tools to manage backlog and testing more efficiently, reduce dead time, never lose samples, track response time metrics, respond to complaints, etc.
• Front-end and back-end integration with process systems (DCS, PLC, SFC, SCADA) for automated data collection and delivery of results to control systems, operators and process historians.
• Comprehensive versioned specification management for manufacturing control and specification limits and for specifications at the product and customer levels.
• Lot release/usage decision features to control product release and ship.
• Comprehensive, open and flexible COA facility that is fully configurable to the product and customer level including layout, content, units, significant digits, etc.
• Bi-directional integration with SAP-QM or SAP Batches for finished product testing. Interfaces to other ERP/MES systems available.
• Automated statistical control for both manufacturing and laboratory QC using Shewart, Western Electric, Westgard, Cusum.
• Streamlined delivery of event notification and results to end users via e-mail, fax, etc.
• Streamlined delivery of data to desktop productivity tools (Excel, Word, Project, etc.) for enhanced analysis and faster response to process problems.
• Versioned control of SOP documents, specifications, analytical documents, maintenance procedures, etc. for standards compliance (GLP, ISO, etc.).
• Complete traceability and audit trails to insure accountability and auditability (21 CFR, GLP, etc.)
• Specialized features such as stability, content uniformity, dissolution.