Environmental Monitoring Software

Pharmaceutical environmental monitoring software manages the routine sampling and testing of cleanroom environments in regulated manufacturing. Novatek EM handles sampling plans and scheduling, viable and non-viable data collection, excursion detection, investigations, trending, and reporting in a single validated system.

Novatek EM captures results at the point of sampling using barcoded media and touchscreen entry on cleanroom-capable tablets. Because data is recorded in the cleanroom rather than on paper and transcribed afterward, there is no manual re-entry step and no reconciliation gap between the record and the sample.

Yes. Novatek EM tracks viable sampling through incubation stages and plate reads, and acquires non-viable particle count data directly from particle counters. Both data types trend together, so the picture of a room or process is complete rather than split across systems.

Annex 1 expects a documented contamination control strategy supported by data. Novatek EM supports that with risk-based program design, real-time trending, automated adverse trend detection, and investigation and CAPA records — the evidence an inspector asks for when reviewing how contamination risk is managed.

Yes. Novatek EM reads data directly from particle counters and air samplers, and also integrates with pre-labeled media systems, LIMS, ERP, QMS, and MES platforms.

Yes. Novatek EM runs standalone or connected to an existing LIMS, including where a LIMS is already mandated across the organization. Most LIMS platforms are designed around chemistry workflows; Novatek EM handles the microbiology side — incubation, organism tracking, contamination recovery rates — and passes data back to the LIMS of record.

Yes. Novatek EM supports global rollout with site-level data segregation and centralized administration. Each site sees its own data while quality leadership retains visibility across the network, and the EM program stays consistent between facilities.

Novatek supplies IQ/OQ documentation and execution support, with optional PQ documentation and execution assistance. Validation gap analysis and role-based training are included as part of implementation.