Regulatory - Governmental
Sampling may be a mix of highly structured or ad-hoc and driven by external dynamics that range from managed (environment monitoring) to unpredictable (emergency response). Emphasis is on secure chain-of-custody, data integrity, confidentiality, impartiality, demonstrably correct results, demonstrating and maintaining proficiency and standards compliance, and responsiveness.
BlazeLIMS improves performance in this mission via the following features:
- Comprehensive tracking of samples, containers, aliquots, tests, QC's, etc. to provide complete traceability per NELAC standards.
- Comprehensive Chain of Custody features including legal seals, etc.
- Complete QC functionality (dups, spikes, controls, calibrations, surrogates, container conditions, holding times, etc.) including method based parameterization and templates.
- Complete tracking of Prep and Analytical batches and operations.
- Air tight method management including versioned document control.
- Reagent and consumables tracking/quarantine/release/usage records, highly automated to reduce laboratory labor.
- Demonstration of Capability record keeping.
- Lab/sampling personnel training/certification tracking and enforcement.
- Web or Windows thin client facility for remote request submission to improve response time and accuracy.
- Multi-sample automatic and manual logging features to improve response time and accuracy.
- Flexibility in configuring for specialized sample identification to meet each unusual needs (emergency response, etc.)..
- 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 to demonstrate and enforce integrity.
- Highly flexible and configurable method/testing/calculation capability to support highly varied product/testing mixes.
- Instrument integration via Blaze Link to streamline throughput and reduce errors.
- Automated management of multiple dilutions.
- Numerous tools to manage backlog and testing more efficiently, reduce dead time, never lose samples, track response time metrics, respond to complaints, etc.
- Comprehensive, open and flexible COA/final report facility that is fully configurable to the product and customer level including layout, content, units, significant digits, etc.
- Flexible EDD reporting capability including SEDD support.
- Automated statistical control to provide valued added quality reporting.
- Versioned control of SOP documents, specifications, analytical documents, maintenance procedures, etc. for standards compliance (NELAC, GLP, ISO, etc.). A significant enabler to certification.
- Complete traceability and audit trails to insure accountability and auditability (21 CFR, GLP, etc.)