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QMS
Laboratory Quality Management System
A Laboratory Quality Management System (QMS) is a structured framework designed to ensure the accuracy, reliability, and traceability of test results within a laboratory setting
- Deviation Management
- Laboratory Incident
- Change Management
- Smart Audit
- OOS/OOT Investigation
- CAPA
- Trend Analysis
Deviation management
Deviation management in a laboratory setting is the process of identifying, documenting, investigating, and resolving any departures from established procedures, protocols, or expected results. It's a critical component of quality management in laboratories, especially those regulated by entities like the FDA.
Laboratory Incident Management
A laboratory incident is an unplanned or unexpected event in a laboratory that can negatively impact safety, product quality, data integrity, or regulatory compliance. These incidents can range from minor issues to serious accidents.
Change Management
Change management in a laboratory setting involves effectively guiding lab personnel through alterations to processes, technologies, or workflows, while minimizing disruption and ensuring data integrity
Smart Audit
Smart Audits are digital audits for operators to walk their equipment and check on all conditions and calibrations to ensure that operational machinery and automation systems are safe and ready for optimal output.
OOS/OOT Investigation
OOS (Out of Specification) and OOT (Out of Trend) investigations in a laboratory setting are crucial for ensuring product quality and safety. They involve a systematic process of identifying and addressing results that fall outside established criteria or historical trends.
CAPA
CAPA (Corrective and Preventive Action) is a quality management process focused on identifying, investigating, and resolving issues to prevent recurrence and improve overall quality. It involves both addressing existing problems (corrective actions) and implementing measures to prevent future occurrences (preventive actions).
Trend Analysis
Trend analysis in a laboratory setting is the systematic process of monitoring, evaluating, and interpreting laboratory data over time to identify patterns, shifts, or unusual occurrences. It's a crucial part of quality management, helping to detect potential issues early and ensure compliance with regulations.
