BlazeLIMS for Pharmaceutical Industries
Laboratories serving the Pharmaceutical Industries are dominated by their status as an FDA regulatory domain. Emphasis is on regulatory compliance (GMP, GLP, 21CFR Part 11, etc.), validation status, full traceability, precise sample identification and tracking, documented and insured corrective actions, established and controlled methodology (SOP document management), reproducibility, accountability and tamper proof information. Traceability must be comprehensive of all elements of the laboratory process including prep (scales, pipettes, reagents, technicians, etc.) analysis (primary instrument, technicians, standards, controls, etc.) and the entire laboratory quality assurance process. For smaller enterprises the LIMS may also implement substantial portions of EPR functionality such as recipe/SOP management, raw material, in-process and finished product inventory, and process managements (batch, fill, package, ship).
BlazeLIMS provides all the features necessary to improve performance in the pharmaceutical industry. A few of the more important/applicable features of BlazeLIMS are:
- Full features for 21CFR Part 11 compliant installation and operation.
- Complete traceability of all operations (sampling, prep, analysis, review, approve, dispose) with complete audit trail, tie to reagents and instruments including scales, pipettes, analyzers, personnel, etc.
- Complete metrology for all instrumentation integrated with results review/approval/status.
- Full GMP/GLP tracking and enforcement.
- Validation scripts and assistance.
- Integrated, versioned document management for prep and analytical methods, sampling, instrument maintenance, etc. SOP's, MSDS, captured documents, final reports, etc.
- Corrective action tracking.
- Personnel training and certification tracking and enforcement.
- Comprehensive COC.
- Comprehensive, controlled and flexible production of COA's to include supporting quality data where desired.
- Patient/subject/clinical trials management.
- Integrated stability study management.
- Manual or fully automated control charting including Westgard rules with feedback and notification.
- Full-featured laboratory QC batching with templates.
- Complete instrument interfacing to traditional and clinical analyzers.
- Manufacturing recipe and batch management including make, fill, package, store, ship with complete traceability to raw material and intermediate usage, inventory, etc.