Environmental monitoring software — built for Annex 1 cleanrooms.
V5 schedules, captures and trends every EM sample — viable, non-viable, temperature, humidity, differential pressure — against your cleanroom grade. Excursions trigger investigations automatically and link to the batches in the room at the time.
What breaks without this.
Excursions discovered weeks later
Paper EM logs reviewed at the end of the month miss excursions that should have stopped production the same shift.
Sample-to-batch link is broken
When an EM excursion is found, nobody can quickly list every batch that was open in that room when it happened.
Trending takes the microbiologist a week per month
Pulling action/alert level data into Excel for trend analysis is a full-time job — and trends inform the Annex 1 contamination control strategy.
Records-by-execution. Compliance, by design.
EM sampling plan as a schedule
Every location, frequency, grade, alert and action level configured. Sample tasks land on the EM team's queue at the right time.
Viable + non-viable + utility in one record
Settle plates, contact plates, active air samples, particle counts (0.5µm and 5µm), temperature, RH and ΔP — all sampled and trended in one system.
Real-time alert/action alerts
When a reading crosses an alert or action level, the cleanroom supervisor and QA microbiologist are notified immediately — not at month-end.
Auto-link to batches in the room
Every EM excursion auto-lists the batches in that room at the time of sample, ready for the impact assessment.
Annex 1 contamination control evidence
Trend reports, OOAL/OOSL summaries, isolate identification tracking — packaged as the evidence pack inspectors expect.
Proof points
- Sample-to-batch linkage built in
- Alert / action / OOS level escalation with notifications
- Trend analysis dashboards (per location, per grade, per organism)
- Annex 1 evidence pack export
Built to satisfy
- EU GMP Annex 1 (Manufacture of sterile medicinal products, 2023)
- USP <1116> (Microbiological control and monitoring of aseptic processing)
- USP <797> (Pharmaceutical compounding — sterile preparations)
- 21 CFR 211.42 (Design and construction features)
- 21 CFR 211.113 (Control of microbiological contamination)
- ISO 14644 (Cleanrooms and associated controlled environments)
Frequently asked questions
Does V5 cover both viable and non-viable EM?+
Yes — settle plates, contact plates, active air, finger-dabs, plus 0.5µm and 5µm particle counts, temperature, RH and ΔP, all in one sampling plan.
What happens on an excursion?+
Alert and action levels trigger immediate notification to the cleanroom supervisor and QA microbiologist, the batches in the room at the time are auto-listed, and an investigation record is opened.
Is V5 aligned with the 2023 Annex 1 revision?+
Yes — Annex 1's contamination control strategy expectations (CCS), sampling locations, gowning monitoring and trending requirements are all built into the EM module.
How fast can we deploy?+
EM module onboarding is typically 10–14 days including sampling plan configuration and historical data import for trending baseline.
See V5 on your own line.
Free trial, no card. Live in 7 days with guided onboarding.