Water & Utility Monitoring Software

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.