CLIA (Clinical Laboratory Improvement Amendments) regulations and GCP (Good Clinical Practices) require diagnostic- and research-based clinical laboratories to build clinical laboratory quality assurance and quality controls into products and services.
Often the requirements for clinical laboratory quality assurance cannot be entirely met by clinical laboratories due to time contraints -- a situation that puts both the public and clinical laboratories at risk.
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MasterControl, a developer and provider of software solutions and services for the life sciences industry, provides document control and other quality solutions that are designed to streamline processes associated with product and clinical development and management. This streamlines processes critical to clinical laboratory quality assurance.
For example, the MasterControl Documents solution controls, tracks and effectively automates documentation (SOPs, quality manuals, work orders, clinical lab incident management plans, etc.), while simultaneously providing document collaboration and training integration.
MasterControl also provides clinical laboratory quality assurance by providing software to manage deviations, nonconformances, customer complaints, MasterControl CAPA, audit, change Control, equipment Calibration, project management, and more. These solutions are all web-based and can be configured into a single MasterControl system.
For more information about how MasterControl integrated software solutions can help with clinical laboratory quality assurance, please feel free to contact a MasterControl representative.