Life Science organizations conducting significant research and development are under close scrutiny from government and regulatory agencies and face constant pressure to demonstrate compliance with established protocols. Burdensome or time consuming compliance processes often lead to a decline in productivity during research and to longer discovery and development cycles. This can exponentially increase operating costs and divert valuable resources away from core research functions on which an R&D organization would prefer to focus.
The myriad samples, assets and equipment utilized in Life Science research organizations require constant monitoring, maintenance and other preventive actions to remain compliant and ensure optimal productivity. Monitoring, calibrating and protecting these assets through labor intensive and error-prone manual methods should be seen as outdated and no longer be viewed as a viable option. According to research done by Pharmaceutical Manufacturing, on average, organizations face 35% higher maintenance costs when adhering to compliance standards with these out-of-date approaches. In order to adopt better practices and institute viable SOPs, many industry leaders are turning to paperless, automated platforms that help to manage and monitor valuable assets and equipment at their organizations. Implementing solutions that automate routines and limit manual data acquisition and storage is becoming increasingly important to maintain a competitive advantage in this industry.
Having a proper research sample workflow is critical for any research organization to ensure that samples are used, received, stored or incubated at appropriate temperature, humidity, etc. When monitoring of equipment and recording equipment readouts is all on paper, considerable gaps can grow where data might not be readily available. Industry-leading companies following best practices to prove compliance are implementing autonomous monitoring solutions that protect life science assets and ensure facilities and equipment function optimally. Real-time notifications, digital data acquisition and analysis, and redundant architecture with multiple layers of safety all work to prevent loss, improper reporting, and downtime.
There are many standards and regulations for ensuring laboratory equipment such as refrigerators, freezers, incubators, centrifuges, and even generators are kept in proper operating condition. The FDA and other regulatory agencies mandate certain parameters to be recorded and reported, typically in an electronic, 21 CFR Part 11 compliant form. The FDA requires data to be collected and analyzed to identify any issues throughout research processes. Failure to abide by regulations could result in costly, time-consuming remedial actions in the event of an internal or external audit. In the event of a FDA audit, failing an inspection could result in major financial losses from damaged company reputation, increased regulatory scrutiny, among many other challenges. GxP quality guidelines and regulations further emphasize the importance of establishing proper SOPs and the necessity to maintain daily documentation and reports for all ambient parameters and equipment. It isn’t just laboratory assets and equipment that must adhere to these standards, but also the ambient conditions of the entire facility from temperature and humidity, to particle counts and VOCs. All of these areas must be continuously monitored and measured.
Paper-based or highly manual monitoring often leads to inaccurate data or data gaps, ultimately leading to compliance issues. Without the use of an automated monitoring system, routine, manual tasks and data logging become cumbersome and are often subject to a variety of errors due to oversight or de-prioritization. Having a fail-safe monitoring system that integrates into existing lab processes and proactively mitigates any risks of substantial loss to research materials is increasingly important. In addition, having real-time notifications in the event of an equipment or facility failure forces the organization to design the appropriate response and escalation protocols, and allows it to immediately activate these protocols when necessary. The testing of these protocols often leads to improved SOP’s.
Finally, accurate, real-time data collection from equipment, particularly of temperature on refrigerators and freezers can facilitate predictive analytics, which can be applied to optimizing maintenance schedules and preventing potential failures. This allows an organization to seamlessly integrate their procedures and personnel with all laboratory environments and equipment in order to ensure all proper support systems are in place.
There are many monitoring solutions available for life science industries. Simple, rudimentary sensors or data loggers–which by definition are not in real-time–will eventually have similar problems as the time-consuming manual data entry. These processes are often considered untraceable documentation procedures and are inadequate for review and reporting cycles. Implementation of a real-time monitoring solution that utilizes cloud-based software for wired or wireless monitoring of all types of sensors mitigates common risks found in siloed data loggers and paper-based equipment and asset monitoring. Having a solution in place will increase the quality and traceability of your data.
Each organization differs in how they approach monitoring ambient parameters and equipment for deviations and anomalies, but having a real-time monitoring of all fa cility conditions and equipment will dramatically increase the likelihood that an organization will, over time, maintain the integrity of its scientific assets. The status quo of data loggers, or paper-based checklists might let you know that a problem has already occurred, but with real-time monitoring, you know the minute there’s a deviation and through predictive analysis, can prevent problems from developing in the future.