#1 Trusted
by Healthcare Systems Nationwide
cGMP Environmental Monitoring for Pharma and Biotech
Continuous, cGMP-validated monitoring across every cleanroom, stability chamber, cold storage unit, and warehouse in your operation — logged automatically, always audit-ready, and completely independent of your facility’s IT infrastructure.
Trusted Leading Healthcare Facilities Nationwide
Every Batch Protected. Always Audit Ready.
cGMP Monitoring, End to End
ISO cleanrooms. Stability chambers. Ultra-low freezers. Raw material warehouses. Every critical environment in your manufacturing operation — monitored continuously from one integrated platform, with no gaps in your compliance record.
FDA Compliance. Validated & Ready.
Fragmented data loggers create fragmented audit trails. PharmaWatch generates validated, tamper-proof electronic records that support FDA 21 CFR Part 11, Part 210, and Part 211 — automatically, from one system, across every site.
From Pilot Plant to Global Network
Cellular sensors deploy independently of your IT infrastructure. Scale from a single pilot plant to a global manufacturing network — no IT approvals, no network headaches, no implementation project.
Engineered Around What Actually Fails
Built Different. On Purpose.
Cleanroom & Differential Pressure Monitoring
ISO classifications aren't suggestions — they're requirements. PharmaWatch continuously tracks temperature, humidity, and differential pressure across sterile compounding areas and airlocks. The second a pressure cascade drifts, your QA team knows.
One Dashboard. Every Facility. Worldwide.
Main plant. R&D labs. Distribution warehouses across three continents. Quality Directors get real-time visibility across your entire global network — without juggling multiple monitoring systems or chasing local facility managers.
Predictive Alerts That Save Batches
A failing stability chamber doesn't just destroy product — it destroys months of validated process data. PharmaWatch spots struggling equipment weeks before failure so you schedule maintenance instead of emergency batch reviews.
It’s automated
Compliance Without the Paper Chase.
Pharmaceutical compliance is unforgiving. cGMP mandates strict environmental documentation for every manufacturing environment. FDA 21 CFR Part 11 governs electronic records. Part 210 and 211 set the bar for current good manufacturing practice. The cost of non-compliance isn't just regulatory — it's batch rejections, product recalls, and a reputation that takes years to rebuild.
PharmaWatch takes the manual burden off your QA team entirely. Our validated platform logs every critical environmental parameter continuously and generates tamper-evident electronic records your FDA inspector expects to see. When they walk in, your QA manager pulls a comprehensive compliance report with OneClick™ Audit Support — in under 60 seconds.
Backed by a 100% U.S. based support team trained in regulated healthcare environments — ensuring fast response, expert guidance, and uninterrupted protection.
Our team is here for you.
24/7 • 365
Happy Customers
98% NPS Score
Our features
How PharmaWatch Protects Your Manufacturing Operation.
Prevent Batch Losses
A compromised stability chamber or drifting cleanroom doesn’t just waste product — it wastes months of validated process data. PharmaWatch catches problems early so your batches stay on track and your validation work stays intact.
Facility-Wide Visibility. No Blind Spots.
Cleanrooms, stability chambers, cold storage, raw material warehouses — every critical environment in your operation monitored continuously with tamper-evident data accessible from any device, anywhere in the world.
Thresholds Built for Your Process
A raw material warehouse and an ISO 5 cleanroom have radically different requirements. PharmaWatch configures precise alert parameters for each environment — so every alarm is relevant and every silence is defensible.
Automatic Escalation When It Counts
Shift operator misses an alarm? QA Director gets notified. Then Facilities Management. Three-tier Smart Alert escalation ensures every critical alert reaches a decision-maker before the excursion becomes a batch failure.
Customizable Role-Based Access
Plant managers, QA leads, lab techs, global compliance directors — each role gets a purpose-built view with exactly the access they need. Fully configurable across global, multi-site operations. FDA 21 CFR Part 11-compliant from day one.
Indefinite, Secure Data Archiving
All environmental data stored indefinitely in a globally redundant, FDA 21 CFR Part 11-compliant cloud. Ready for FDA inspections, EMA audits, or client qualification reviews — pulled in 3 clicks, any time.
Frequently ask a questions
Find the answers here
How does PharmaWatch help pharma facilities pass FDA inspections?
Our platform generates continuous, timestamped, tamper-evident electronic records that meet FDA 21 CFR Part 11 requirements. When an inspector arrives, your QA team uses OneClick\u2122 Audit Support to produce a comprehensive report for any cleanroom, stability chamber, or warehouse in under 60 seconds.
Can your system monitor differential pressure for ISO cleanrooms?
Yes. We provide continuous monitoring of differential pressure, temperature, and relative humidity in your cleanroom environments. If your HVAC system fails to maintain proper pressure cascades, your team is alerted immediately.
Do you provide IQ/OQ/PQ validation for cGMP environments?
Yes. We deliver full Installation Qualification, Operational Qualification, and Performance Qualification protocols and documentation for pharmaceutical and biotech facilities under cGMP, satisfying both FDA and EMA regulatory requirements.
How does sensor calibration and recertification work?
Our ISO 17025-compliant calibration exchange program handles it. We ship NIST-traceable replacements before your current sensors expire. Your team swaps them and returns the old ones. Zero downtime, no on-site calibration costs.
Why not just use our Building Management System (BMS)?
BMS platforms are designed for HVAC control, not regulatory compliance. They're rarely validated to FDA 21 CFR Part 11 standards. PharmaWatch operates as a dedicated, validated monitoring platform that keeps critical environmental data separate, secure, and inspection-ready.
Can we monitor global manufacturing plants from one account?
Yes. Quality Directors and Global Facilities Managers can oversee every manufacturing plant, R&D lab, and distribution warehouse worldwide from a single centralized dashboard with role-based access.
What happens during a facility-wide power outage?
Our sensors operate independently of your facility's power and network. Onboard battery backup and local storage keep recording through outages. Data syncs automatically when connectivity returns, no gaps in batch records or compliance documentation.
How does PharmaWatch handle multi-site pharmaceutical operations?
One portal, every site. Current environmental status, excursion history, compliance records, and calibration documentation are all visible across every facility from a single dashboard. Because the system is cellular-based, adding a new site or a new building doesn't require coordinating with that location's network infrastructure. It's particularly useful for organizations managing multiple manufacturing sites, distribution centers, or R&D campuses — you get enterprise-wide visibility without an enterprise-wide IT project.
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