GMP-grade facility intelligence. Continuously validated.
Pharmaceutical and biotech facilities operate under the strictest regulatory frameworks. SiteIQ provides continuous environmental monitoring, cleaning validation, and audit-ready documentation architected to support EU Annex 1 and ISO 14644 environments — without manual logging or after-the-fact binder assembly.
The most regulated environments still rely on manual logs.
Quality teams sign off on excursions hours after they happen. Inspectors arrive expecting continuous, attributable data — and find paper logs and disconnected systems.
- FDA Warning Letters citing environmental monitoring deficiencies rose ~23% in 2023–2024
- EU Annex 1 (2023) requires continuous monitoring with full data integrity controls — manual logging no longer sufficient
- Contamination excursions cost $50K–$500K per incident in batch loss, investigation, and remediation
- Regulated environments demand electronic records with complete, attributable, contemporaneous, original audit trails (ALCOA+)
Continuous validation isn't a future requirement. Inspectors expect it now.
Capabilities for Life Sciences
CONTINUOUS ENVIRONMENTAL MONITORING
Temperature, relative humidity, differential pressure, and viable/non-viable particulate continuously sampled across cleanrooms and controlled environments. Threshold breaches alert in seconds, not on next-shift review.
CLEANING VALIDATION DOCUMENTATION
GPS-verified, timestamped cleaning records for every controlled space. Coverage, dwell time, and product/lot association captured automatically — ready for QA review and inspection.
DATA INTEGRITY & AUDIT TRAILS
Electronic records with full audit trails and access controls. Architecture designed to support regulated environment requirements as capabilities expand.
DIFFERENTIAL PRESSURE MONITORING
Continuous pressure-cascade monitoring across classified rooms and airlocks. Cascade reversals or drift events trigger immediate alerts and a documented investigation record.
AUDIT-READY REPORTING
Pre-formatted reports for EU Annex 1, ISO 14644, and internal QA. Investigators get exportable evidence packages in minutes — not weeks of binder assembly.
"Continuous monitoring with data integrity I can defend."
Built for life sciences decision-makers.
Director of Quality
"Continuous monitoring with data integrity I can defend."
Electronic records, ALCOA+-aligned audit trails, and inspection-ready documentation architected to support regulated environments across every controlled space.
Facilities Director
"Visibility into HVAC, pressure, and environmental performance — without surprises."
Real-time facility telemetry tied to GxP impact, with predictive signals on critical utilities and HVAC.
VP Manufacturing
"Protect every batch."
Operational dashboards that link environmental conditions to product/lot, reducing excursion risk and accelerating release.
Frequently asked questions
See your life sciences facility differently.
Pilot continuous environmental monitoring in one cleanroom suite. Generate audit-ready documentation architected for regulated environments from day one.
Request a Compliance Assessment