As Life Sciences labs continue to ramp up the speed of innovation, standardized management of controls and processes need to be enforced to ensure the reliability, reproducibility, and high integrity of not only all the data produced, but also the processes around monitoring and managing all activities in the labs themselves. GxP quality guidelines and standards are necessary for the safety and integrity of products manufactured - this is especially important in the life sciences industry, as most of the final products are intended for human use.
GxP compliance in organizations includes the ability to ensure all processes and digital data records are trustworthy, reliable, and cannot be manipulated. This includes keeping track of any unusual events detected by systems, like deviations or anomalies across all equipment found in the lab. This information is required to be provided to government agencies, like the FDA. The reports need to include supporting documentation that reflects incidents and that no step in the process was compromised or manually edited. This is necessary to determine whether the level of deviation does not negatively impact the final product and ultimately deem it unsafe for use.
The challenge for many organizations to ensure GxP compliance is having access to best-in-class lab monitoring solutions that automatically export thorough reports required by government agencies to successfully complete audits. By not automating the generation of reports in non-editable formats the task is not only laborious, and at risk of human error, but also does not comply with governmental agency guidelines stating the data and reports cannot be manipulated. By implementing incident reporting features, organizations have the ability to monitor and report on any deviation or anomaly detected by lab monitoring solutions and be able to automate reports. This further enforces GxP and ensures compliance across the organization.
IMAGE: Automatic incident report generated by TetraScience Lab Monitoring application
The TetraScience Lab Monitoring application, built on top of the TetraScience Data Integration Platform, is designed for GxP labs to enable 21 CFR part 11 compliance through features such as comprehensive audit trails, electronic signature, multi-factor authentication, and others. The addition of incident reporting to the Lab Monitoring application will enable Life Sciences organizations to automatically generate comprehensive incident reports that reflect all deviations detected across equipment in the lab - and at a click of a button. This will save organizations time, resources, and enable their compliance and operational integrity.
The application combines cloud-native and web-based user experience with reliable hardware that supports 5GHz Wi-Fi, cellular, and hardwired connections. Built on infrastructure that makes data accessible and secure, it meets all data integrity requirements necessary.