Kelab Quality Assurance Unit
At Kelab Analitica, quality is our top priority. Our Quality Assurance System covers all areas including; sample collection, transport, analysis, data review and reporting. Our best practices have been documented and are, where appropriate, consistent with:
- The International Organization for Standardization’s ISO/IEC 17025 – General Requirements for the Competence of Testing and Calibration Laboratories.
- Resolution 3619 de 2013: Manual de Buenas Prácticas de Laboratorio de Control de Calidad de Productos Farmacéuticos
The Kelab Quality Assurance Program includes:
Laboratory Information
Management System (LIMS)
Our specialized Laboratory Information Management System (LIMS) handles all the sample log-in, scheduling proccesing QC data, test results, routine calculations, reporting and sample storage assignments for the laboratory.
Electronic Document
Management System
Centralized system for managing and tracking all of Kelab’s Quality documents including workflow-based tasks
Standard Operating
Procedures
Controlled documents used to define and describe each routine analysis performed by our laboratory.
Method Validation
Documented process of ensuring our test methods are suitable for the intended use
Certified reference materials
High purity certified controls traceable to highly characterized material used in the calibration of instruments and quantitative analytical measurements
Training
All our personnel receives the training required to comply with the demands of the position within the company.
Instrument Operation Procedures
Detailed instructions for the use and care of the analytical instrumentation