Laboratories for the Biotechnology industries may be in support of R&D and/or manufacturing. They are characterized by a high stake in comprehensive data capture and subsequent data management. Activities range from designing and managing experiments to developing and executing reproducible manufacturing processes. There is high value in data sharing and efficient access to archival information. Data quantities can be large and must be gathered with a high degree of automation and with traceability through sometimes complex processes. There are a large number of smaller or startup Biotechnology laboratories where low cost and broad functionality are critical.
BlazeLIMS improves performance in this mission via the following features:
- Low cost and broad functionality across the supply chain make BlazeLIMS attractive to smaller or startup laboratories who can avoid investing in the short term solution of developing custom Access or Excel applications.
- Functionality to cover entire supply chain for small to medium sized enterprise, include procurement, orders, production runs, batches, specifications, SOP's, document management, packaging, shipping, tracking, disposal, invoicing, etc.
- Complete tracking of raw materials, intermediates, finished products, reagents, consumables, instrument metrology, personnel qualifications, quality events, etc. to provide the total data picture.
- Functionality to cover r&d and manufacturing for small to medium sized enterprise.
- Versioned control of SOP documents, specifications, analytical documents, maintenance procedures, etc. for standards compliance (GLP, ISO, etc.). Integration with LabCore for total content management.
- Complete traceabiliy and audit trails to insure accountability and auditability (21 CFR, GLP, etc.)
- Specialized features such as stability, content uniformity, dissolution.
- 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.
- Numerous highly configurable sample identification fields provide ease of use and ability to capture a broad range of identifiers.
- 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. Features available to support high throughput screening paradigm.
- Comprehensive versioned specification management for manufacturing control and specification limits and for specifications at the product and customer levels.
- Comprehensive, open and flexible final report and 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.