In highly-regulated industries like pharmaceuticals, medical devices, and food and beverage, transparency and accuracy are essential to success. Changing technologies, an evolving regulatory landscape, and increasing demands for consumer visibility make this process even more complicated. That’s why it’s critical to have the right tools to ensure compliance.
Environmental monitoring is the observation and collection of environmental data (e.g., temperature, humidity, pressure), typically to ensure consistency in the conditions and meet regulatory requirements. Monitoring systems can also act as alarms, warning companies as certain conditions may go out of their desired range, so that action can be taken before product potency or efficacy is impacted. Having environmental monitoring systems in place can mean the difference between business as usual and a failed audit, or even failed treatment. Monitoring essential data from R&D to production can help protect assets, the bottom line, and patients.
The Benefits of Environmental Monitoring
Product quality: When you’re manufacturing products designed to impact human wellness, there need to be assurances that your product identity, strength, and quality are not compromised. Temperatures that are too hot or too cold can impact the effectiveness of certain components. Humidity can also introduce moisture and damage. Finding the right temperature monitoring system can guarantee audit compliance and patient safety.
Long-term ROI: Upgrading your environmental monitoring system to a more automated, cloud-based solution can save manufacturers money in the long run. These systems reduce the chance for human error and provide real-time excursion alerts – preventing costly product loss and freeing up employees to handle other tasks. The automation and long-term savings offered by these systems can help companies realize a significant return on their initial investment.
Audit compliance: continuous monitoring and digital logs can help you easily adhere to regulatory requirements and reduce the risk of non-compliance during audits. By having ongoing data on critical environmental conditions, you can provide documentation on consistency as well as evidence on how excursions were addressed.
Operational efficiency: Cloud-based solutions eliminate the need to manually go to each sensor and collect charts or download data. Instead, environmental data is pushed automatically to a central location that can be accessed by anyone with permissions, from anywhere, at any time. Cloud options also save time and resources for internal IT teams, who no longer need to dedicate extended periods on maintaining servers and software.
R&D accuracy: In the laboratory, results must be repeatable, and you need to understand the exact conditions that resulted in your success. Environmental monitoring solutions can be the difference between an IND application and going back to the drawing board.
Patient safety: Since environmental monitoring tracks essential environmental conditions, you can ensure that your products are consistent throughout the entire process – from R&D to patient use. This helps guarantee that end users are safe in the long run.