Water & Utility Monitoring Software
Novatek UM is water and utility monitoring software for pharmaceutical and biotech manufacturing. It runs the full utility monitoring process in one validated system — risk-based program design, protocols and specifications, scheduling, sampling and inline data acquisition, excursion detection, investigation and CAPA, review, trending, and reporting. Pharmaceutical water, clean steam, HVAC, and process gases in one place, instead of four.
The Complete Utility Monitoring Workflow
Most systems handle one utility and leave the rest to spreadsheets, logbooks, or a maintenance system that was never built for GMP data. Novatek UM connects the whole program in one place, across every utility, so data moves from the sample port to the trend report without being re-entered.
What Changes When Utility Monitoring Runs in One System
Pharmaceutical water, clean steam, HVAC, and process gases monitored under one program, one specification structure, and one audit trail. When an inspector asks how utilities are controlled, the answer is one system, not four owners.
Direct interfaces to inline instruments and lab equipment mean the record builds as the process runs. You see a system drifting while you can still act on it, instead of finding it in a quarterly review.
Rolling specifications and distribution analysis let you set alert and action levels against your own historical performance, then recalculate them annually as the system ages — with the statistical basis documented.
Trending across systems, ports, organisms, and time, with pattern analysis that traces a recurring count back to its source rather than closing each excursion as an isolated event.
Site-level data segregation with global visibility. Local quality sees its facility, quality leadership sees every site, and best practices move between plants instead of stopping at the fence line.
Built for the Way Utility Monitoring Actually Runs
Sampling programs built by system, loop, and point of use. Specifications set per test and per port, so one update pushes a limit change across the whole program. Expired or unqualified media is blocked before it's used.
Barcoded labels and scan-driven entry record the result at the sample port, with offline capture where there's no coverage. Reconciliation shows what was collected, what's outstanding, and what's waiting on approval.
- Direct interfaces to inline instruments, lab equipment, and microbial ID systems. Every monitored parameter lands in one record without transcription.
- [Chip row: Bioburden · TOC · Conductivity · Endotoxin · Temperature · Humidity · Air change · Differential pressure · Particles 0.5 µm · Particles 5.0 µm]
- Every HVAC protocol defined, scheduled, and calculated in the system — no spreadsheet step between the measurement and the record.
- [Chip row: Balancing · Airflow velocity · Airflow pattern · Air changes per hour · Pressure cascade · Filter integrity · Smoke testing · Classification · Recovery time]
Trend across systems, ports, and organisms. Distribution analysis supports setting alert and action levels against your own data, and ad-hoc queries answer inspector questions during the audit itself.
Built for Regulated Pharmaceutical Utility Monitoring
Compliance & Data Integrity
- Compliant with 21 CFR Part 11 and EU GMP Annex 11
- Built to support EU GMP Annex 1 expectations for utility trending, water system monitoring, and excursion investigation
- Built to support USP and Ph. Eur. compendial monitoring requirements for pharmaceutical water
- Configurable audit trail
- Electronic signatures
- Data integrity controls native to the platform, not bolted on
Validation
- Full IQ/OQ/PQ validation delivered against the GAMP 5 V-model and aligned to FDA CSA guidance
- Process definition for production use
- SOPs written to your processes
- Role-based training and best practice review
- Updates ship with the qualification documentation needed to maintain the validated state
Deployment & Fit
- Cloud or on-premise deployment
- Runs standalone or connected to Nova-LIMS, your existing LIMS, ERP, QMS, or MES
- Direct interfaces to inline instruments, lab equipment, and microbial ID systems
- Runs alongside Novatek EM as a single contamination control record
- Site-level data segregation with centralized administration
Resources for Evaluating Environmental Monitoring Software
Case Study
Sanofi Genzyme Digitizes Environmental & Utility Monitoring with Novatek
Novatek International helped Sanofi Genzyme's Lyon, France manufacturing site replace manual, paper-based environmental and utility monitoring with an industry-focused digital solution — improving data integrity, automating trend analysis, and cutting workload.
- 12-week implementation, start to finish
- Automated trend analysis replacing manual review
- A sharp rise in samples taken, protocols created, and specifications defined
"The project is a success, the QC department of Sanofi Genzyme has entered the realm of digitalization of its activities!"
— Yann Badinga, Project Lead at Sanofi Genzyme
Utility Monitoring Software: Common Questions
Pharmaceutical utility monitoring software manages the sampling, testing, and trending of the utility systems that supply regulated manufacturing — pharmaceutical water, clean steam, HVAC, and process gases. Novatek UM handles program design, specifications, scheduling, sample collection, instrument data acquisition, excursion detection, investigation, trending, and reporting in a single validated system.
Pharmaceutical water at every grade defined in USP and Ph. Eur. — potable, purified water, highly purified water, and water for injection — plus clean steam, HVAC and cleanroom systems, and process gases including nitrogen, compressed air, and oxygen. Monitoring types include bioburden, TOC, conductivity, endotoxin, temperature, humidity, air change, differential pressure, and particle counts at 0.5 µm and 5.0 µm.
Annex 1 expects regular trend analysis of critical parameters on high-risk utilities, ongoing chemical and microbial monitoring of water systems, documented investigation of alert and action level excursions, and periodic microbial monitoring of gases at the point of use. Novatek UM supports each of these with scheduled monitoring programs, automated excursion detection, investigation and CAPA records linked to the excursion, and trending that shows whether an excursion is isolated or indicates system deterioration.
Yes. Novatek UM manages HVAC protocols for both initial validation and ongoing verification, including balancing, airflow velocity and pattern visualization, air changes per hour, pressure cascade, filter integrity and smoke testing, cleanroom classification, and room recovery time after shutdown. Calculations are automated, and results trend alongside routine monitoring data so filter performance can be tracked across its lifecycle.
Alert and action levels are process control indicators that flag when a water system is trending outside its normal microbial control range. Set below the compendial limits in USP and based on your own system's performance history, they give you warning while the system is still in specification — which is what prevents objectionable organisms from reaching a point of use.
Meet the requirement of the market the product is destined for. If a product is manufactured or sold in both the United States and Europe, hold the system to the more stringent limit. Novatek UM supports specifications set per system, per port, and per test, so a single water loop can be held to different limits where different products or markets require it.
Yes. Novatek UM interfaces directly with inline instruments for continuous monitoring, with lab equipment, and with microbial identification systems. It runs standalone or connected to Nova-LIMS, an existing LIMS, ERP, QMS, or MES, so utility data can flow back to the system of record while the monitoring program itself stays in a system built for it.
Yes. Novatek UM and Novatek EM share a platform, so cleanroom and utility data sit in one contamination control record. Annex 1 treats contamination control as a set of interrelated measures whose collective effectiveness must be assessed together — which is difficult when the utility data and the environmental data live in different systems.
Novatek delivers full IQ/OQ/PQ validation against the GAMP 5 V-model, aligned to FDA CSA guidance, along with process definition, SOPs written to your processes, and role-based training. Software updates ship with the qualification documentation required to apply them and maintain the validated state of the system.
Ready to Get Started?
Tell us which utilities you monitor and how you currently schedule, collect, review, investigate, and trend the data. We'll show you how Novatek UM would run it, not a canned walkthrough.