In regulated manufacturing, environmental conditions and critical equipment that can directly affect product quality, yield, and ultimately, patient safety must be monitored. Many facilities install a Facility Monitoring System (FMS) to track airborne particle counts, temperature, humidity, and other parameters. While some do so only to meet regulatory expectations, the real value lies in the tangible business benefits: reduced waste, improved yield, higher quality, and increased profitability.
Why regulators expect facility monitoring
At its core, regulatory guidance exists to minimise risk. A well-implemented FMS improves the probability of detecting hazards before they compromise the process. For example, if no particle monitoring probes are positioned near critical manufacturing points, the chance of catching contamination is zero. Real-time monitoring ensures that excursions are detected immediately, enabling faster root cause analysis and preventing large-scale product loss.
From data to knowledge
Raw environmental and critical equipment monitoring data is only valuable when transformed into actionable information. Continuous monitoring, paired with advanced software, provides alarms, trend analysis, and process insights in real time. This allows operators to intervene before processes drift out of control—reducing downtime, waste, and batch segregation, without compromising safety.
Modern monitoring systems also support energy savings initiatives. For example, with the assurance of continuous environmental oversight, facilities can safely adjust air change rates and velocities to reduce utility costs while maintaining compliance.
Beyond particles – real-time microbial awareness
With the availability of Alternative Microbiological Methods (AMMs), such as TSI BioTrak™ Real-Time Viable Particle Counter, a biofluorescent particle counter (BFPC), facilities can assess microbiological air quality instantly. This enables true real-time process control and minimises the delay and risks associated with traditional culture-based methods.
Smarter factories, smarter decisions
The future is interconnected. In smart manufacturing, environmental data will integrate seamlessly with other operational systems, allowing predictive analytics to anticipate issues before they occur. By centralising monitoring data, decision makers can proactively protect yield and reduce manufacturing costs.
Why choose TSI FMS with FMS Web Client?
TSI’s FMS Monitoring System, paired with TSI FMS Web Client, delivers advanced monitoring with maximum reliability and flexibility:
- Anywhere access – view and manage facility data from a laptop, tablet, phone, or desktop.
- Uninterrupted compliance – high availability SQL databases, real-time mirrored backups, and full system failover (no manual intervention) ensure operations stay online.
- Multi-sensor compatibility – supports TSI instruments (AeroTrak™, BioTrak™ BFPC, Active Air Samplers) and other manufacturers’ devices for particle counts, temperature/humidity, differential pressure, air velocity, CO2 and more.
- Regulatory ready – fully GAMP® compliant and supports 21 CFR Part 11 requirements.
- Actionable alerts – configurable alarms with email, SMS, and phone notifications, plus intuitive status windows and map views.
- Powerful reporting – user-defined reports, automated outputs, and easy export tools for audits and compliance.
Bottom line
Having a monitoring system isn’t just about meeting regulations—it’s a smart investment that boosts process reliability, safeguards product quality, and enhances profitability. With TSI’s FMS Monitoring System and FMS Web Client, you get unmatched performance, streamlined compliance, and effortless operation—delivering the data confidence you need to make faster, better decisions.
See TSI FMS Monitoring System and FMS Web Client in action anytime, anywhere — watch our quick tips here
