A LIMS that ensures SOPs are followed but also allows me to add new processes easily?
Regulated labs must document all aspects of their processes, train staff on these processes, and collect evidence that these processes are followed correctly. Additionally, deviations from standard process must be documented as well.
BaseSpace Clarity LIMS helps you address quality management program requirements and ensure SOPs are followed by providing:
- Extensive system and user documentation that you can use to create lab procedure manuals
- Configurable electronic signatures, designed to the 21 CFR Part 11 standards
- A variety of training programs that you can access online or implement onsite to certify that lab staff are trained
- Enforcement of data entry and production workflows
- Reagent, controls and lot tracking
- Alerts when samples fail testing procedures, for easy resolution and documentation by lab management
- Failsafe tracking of all events for compliance and easy retrieval
Samples which do not meet organizational-specific criteria (e.g., not passing specified quality thresholds) are escalated to management review through BaseSpace Clarity LIMS alerts. Managers must document resolution of the alert in the system for a sample to progress. In the example below a sample, which failed Bioanalyzer quality criteria, has been escalated for management review. The resolution, in this case a request for a new sample, must be documented and next steps assigned.