Proving quality and compliance should be at the forefront of every life science organization’s processes. There are many areas throughout the life science product and drug development lifecycle that organizations are required to prove quality and compliance with myriad regulations and standards such as: GxP, FDA, CAP, CLIA, GAMP, HACCP, JCAHO, AABB, AAALAC, USP 797, etc.
Having a comprehensive laboratory monitoring solution to closely monitor equipment functionality, facility conditions, and ambient parameters is an important tool for not only proving quality and compliance but also performing root-cause analysis after an incident occurs. Here are 5 of the ways lab monitoring improves quality and compliance.
1) Added Layer of Security
There are many levels and layers to an organization’s structure. Each individual department or business unit has certain responsibilities that they oversee. The facilities and operations team is entrusted to ensure lab equipment is functioning properly and ambient parameters are not adversely influencing experiment results. In the event of an internal or external audit, a robust laboratory monitoring solution provides a holistic view into equipment and lab conditions that may have affected results. The additional oversight and control allows for continuous process improvements and immediate notifications in the event equipment fails or deviations occur.
2) Protected Assets & IP
In the highly competitive life science industries, and with so many different departments and areas to manage, having a comprehensive laboratory monitoring solution to protect invaluable samples, assets, and Intellectual Property (IP) is necessary for life science organizations to safeguard their investments. Protecting valuable samples and maintaining optimal storage conditions of promising candidates facilitates a faster time to market. A comprehensive laboratory monitoring solution enables effective quality systems and provides the necessary protection to ensure that a company’s assets are safeguarded.
3) Automated Reporting
Generating reports for quality and compliance can be cumbersome and is prone to errors if data is recorded manually. Paper-based, manual records also pose risks in being illegible, damaged, or lost. Utilizing a lab monitoring system that provides digital data collection and automated reporting is a secure way to optimize all reporting processes, whether it be for internal or external quality and compliance documentation, or specific reports to improve lab operations.
4) Audit Readiness
There is a lot to consider when preparing for an audit. Perhaps the most important aspect in audit readiness is to ensure that there is active monitoring to prove overall control of systems. An organization’s processes can often be categorized in several key systems:
- Facilities & Equipment
- Packaging & Labeling
Monitoring for equipment, ambient parameters and other areas is an important component for each of these systems. A robust monitoring solution ensures all operations are functioning optimally and provides the necessary reporting and documentation to prove compliance with regulations and standards.
5) Improved SOPs
Employees are the most valuable resources an organization has. For any company aiming to innovate, providing employees with optimal working environments is important. Scientists and lab staff interact with equipment daily and often develop routines or patterns for using each device. Closely monitoring equipment and conditions such as door openings, temperature fluctuations, and gas concentration, provides a holistic view of how employees, equipment and room conditions change over the course of the day. Identifying patterns often reveal gaps in processes or inefficiencies that can be addressed by revising SOPs. With improved SOPs, personnel’s time is better allocated to the important tasks that deliver life science products to market.
XiltriX Lab Monitoring SOlution
XiltriX is the first and only company to offer a robust laboratory monitoring solution and Monitoring-as-a-Service for life science companies. XiltriX leverages over 30 years of life science industry experience--without a failure--monitoring laboratory equipment, conditions and ambient parameters. XiltriX delivers the world’s most robust, advanced monitoring solution, providing predictive analytics for preventive maintenance, as well as improving SOPs and best practices.
The XiltriX Monitoring-as-a-Service package includes implementation, configuration and management of all hardware and software, including all necessary upgrades and updates. The XiltriX Safety Net team proactively manages every aspect of the hardware and software solution, 24/7, so that customers don’t have to dedicate resources to ensure optimal performance. XiltriX is the trusted partner to protect your science and help you sleep at night.