Manufacturing Quality Control
Blaze Systems knows manufacturing for industries from chemicals to biopharma, and BlazeLIMS automates and streamlines the quality process from beginning to end, with ease of use and superior data and workflow integration to other manufacturing systems, for fast turn-around and a total LIMS solution. BlazeLIMS is feature rich to excel in the large laboratory, and priced right for the smaller lab. Features that target QC labs are summarized here. A detailed spec sheet is also available.
- Simple single or multi-sample manual or automatic login from schedules or other systems (ERP) using flexible templates, including skip-lot and other strategies
- Easy-to-use screen suitable for field operators
- Numerous highly configurable sample identification fields provide ease of use and reduced training needs for plant operators.
- Barcode labels for positive identification
- Workflow automation features such as autologging, barcoding, auto-approval options, grouping activities and data by process area, etc. to optimize productivity and reduce errors.
ELN, Prep, Method Execution
- Numerous tools to manage backlog and testing more efficiently, reduce dead time, never lose samples, track response time metrics, respond to complaints, etc.
- Enforcing suitability, managing, certifying, & tracking of reagents, standards, equipment, personnel, environment, documents, holding times
- ELN for all prep and analytical steps, including calculations, instructions, notes, dilutions, signatures
- Specialized features such as stability, content uniformity, dissolution.
- 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 labor and reduce errors.
- Comprehensive versioned specification management for manufacturing control and specification limits and for specifications at the product and customer levels.
- Instant visual and notification feedback of violations
- Automated statistical control for both manufacturing and laboratory QC using Shewart, Western Electric, Westgard, Cusum.
- Lot release/usage decision features to control product release and ship.
- Front-end integration for manufacturing execution systems (MES, ERP) for automated sampling, testing and specification management.
- 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, 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.
- Streamlined delivery of event notification and results to end users via e-mail, fax, etc.
- GxP features
- Security via validated login
- Electronic signature
- Audit Trail for total traceability
- 21CFR Part 11 compliance
- Validation support
- 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.).
- Structured and ad-hoc query