A proactive and risk based approach to quality management systems minimizes the chances for undesired effects as well as continual improvement by predicting potential problems. It also lowers the risk of manufacturing problems that may result in shorter and fewer FDA and EMA inspections. Dot Compliance’s out the box, fully validated eQMS system allows your organization to:
Use Risk Management as a Tool
Evaluate risk severity and probability which serve as the basis for risk level calculation. At Dot Compliance, you can determine the risk priority from risk level and detection level.
Link risk Management to Design & Development activities
Identify risks associated with proposed change or action that can cause incorrect functionality, failure of system or compromised system performance. Dot Compliance helps organizations maintain compliance and oversight by creating an infrastructure for Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) QMS.
Leverage Risk Management as Single Source of Truth
Since risk is any event that may have an undesired impact on patient safety, compliance, or data integrity, life science organizations that have a holistic eQMS providesactions for improvement, reducing risk probability and minimizing the chances for undesired effects across the quality ecosystem.