#1 Trusted
15+ Years in the Healthcare Industry
Automated Temperature Monitoring System for Tissue Banks
Tissue allografts, bone, skin, and corneal tissue stored at the wrong temperature don’t get a second chance. PharmaWatch monitors every critical storage environment in your tissue bank continuously — with automated FDA HCT/Ps, CGTP, and AATB compliance documentation built in from day one.
Trusted by Leading Tissue Banks Nationwide
Every Unit Covered. Every Audit Ready.
Total Monitoring for Every Asset
Tissue refrigerators, frozen allograft storage, cryogenic tanks, and controlled-temperature rooms — all monitored from one dashboard. Your team gets alerted before tissue integrity is ever compromised.
Complete Automated Compliance
Every reading, excursion, and corrective action logged automatically in a tamper-evident audit trail that supports FDA HCT/Ps, CGTP, and AATB requirements. When an FDA inspector walks in, your records are already there.
Effortless Plug-and-Play Installation
Ships pre-configured. Plug it in and monitoring starts immediately — no IT, no WiFi, no setup. Most facilities are live the same day their equipment arrives.
Built different on purpose
What Sets Us Apart
Virtual Temperature Buffering™ (VTB™)
Standard sensors alarm on air temperature — a door opening triggers an alert that pulls staff away from more important work for no reason. PharmaWatch uses patented VTB™ to model actual tissue temperature algorithmically, so alarms fire when something is actually wrong. No physical glycol buffers near your tissue products. No contamination risk.
Centralized Control for Your Entire Network
One dashboard across every tissue storage unit, freezer, and controlled room in your facility — or across every facility your organization operates. Everything visible from one screen, any device, anywhere, without managing separate systems for each site.
Equipment Health & Predictive Failure Alerts
PharmaWatch watches equipment behavior patterns and flags degrading equipment before it fails. For tissue banks storing allografts worth thousands of dollars per unit, catching a compressor issue early isn’t just convenient — it’s the difference between a maintenance call and a catastrophic inventory loss.
Automated Compliance
Audit-Ready Without the Last-Minute Scramble.
Tissue banks operating under FDA HCT/Ps and CGTP regulations require continuous environmental monitoring with complete, traceable documentation for every storage environment and every excursion event. PharmaWatch generates that documentation automatically — every reading, every alert, every acknowledgment — continuously, from day one.
When an FDA inspector arrives, your team pulls a complete compliance report in three clicks. Calibration certificates are permanently linked to each device record. IQ/OQ/PQ validation documentation is included in every deployment. There’s nothing to prepare because it’s always ready.
Compliance Standards We Support:
FDA HCT/Ps and CGTP — direct compliance
Supports compliance with FDA 21 CFR Part 11
FDA GxP / cGMP
NIST-traceable calibration/ ISO 17025
IQ/OQ/PQvalidation included in every deployment — not sold separately
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
What Sets Us Apart
Protect High-Value Tissue Inventory
Tissue allografts aren't replaceable on short notice. A storage failure doesn't just affect compliance — it affects patient care. Cellular transmission and a 5-day battery backup mean your inventory is covered no matter what.
Continuous Visibility Across All Storage
Every tissue refrigerator, frozen allograft freezer, and cryogenic storage unit visible from one screen. Current status, trend data, and excursion logs — three clicks away, any device, any hour.
Product-Specific Alert Profiles
Fresh tissue, frozen allografts, and cryopreserved materials all have different storage requirements. Alarm thresholds are fully configurable per zone so your team gets the right alert for the right environment.
Multi-Tier Escalation Notifications
If an alert goes unacknowledged, it escalates automatically — by call, text, or email — until the right person responds. Three tiers, zero missed alerts.
Role-Based Dashboard Access
Tissue bank directors, QA staff, and compliance teams each see what they need. Fully configurable access levels with a complete log of who viewed what and when.
Indefinite Compliant Record Retention
All data stored on globally redundant servers, permanently accessible — whether you need it for an AATB audit next week or an FDA inspection in three years.
Frequently ask a questions
Find the answers here
Why do tissue banks need a specialized monitoring system?
Tissue allografts, bone, skin, and corneal tissue have strict storage requirements and zero tolerance for excursions. A monitoring gap under FDA HCT/Ps and CGTP isn’t just a documentation problem — it’s inventory that may need to be quarantined or destroyed. PharmaWatch was built for regulated tissue banking environments, with FDA compliance documentation built into the system from day one.
How does PharmaWatch support FDA HCT/Ps and CGTP compliance?
PharmaWatch directly supports FDA HCT/Ps and CGTP compliance requirements for tissue banking. Every reading is automatically logged with timestamps, user IDs, and resolution notes in a tamper-evident audit trail. When an FDA inspector asks for storage records, you pull them up in under a minute — complete, continuous, and ready.
What storage environments does PharmaWatch monitor for tissue banks?
Refrigerated tissue storage (1–10°C), frozen allograft storage (−20°C to −40°C), cryogenic storage down to −196°C, and controlled-temperature rooms. All monitored continuously from one dashboard, with fully configurable alarm thresholds for each storage class.
How does VTB™ protect tissue products from false alarms?
Virtual Temperature Buffering™ (VTB™) calculates actual tissue product temperature algorithmically rather than reacting to air temperature swings from door openings. Staff don’t get pulled away by false alarms — and because there’s no physical glycol buffer near your tissue products, there’s no contamination risk in sterile storage environments.
How does calibration work without interrupting monitoring?
PharmaWatch uses individually serialized, ISO 17025 pre-calibrated probes with a 2-year interval. A new probe ships automatically before your NIST expiration. Swap it in 60 seconds — the monitoring record stays continuous and the calibration chain never breaks. Every certificate is permanently linked to the device record in the portal.
How does PharmaWatch handle FDA audit readiness for tissue banks?
Every reading, excursion, alert, and response is automatically logged in a tamper-evident record that supports FDA HCT/Ps, CGTP, and FDA 21 CFR Part 11 compliance. IQ/OQ/PQ documentation is generated continuously by the platform. Calibration certificates are permanently linked to device records. When an FDA inspector arrives, everything is already there — nothing to reconstruct.
Do you provide IQ/OQ/PQ validation documentation?
Yes — included in every deployment, not sold separately. Installation Qualification, Operational Qualification, and Performance Qualification documentation is generated continuously by the platform itself. It’s current, permanent, and accessible through the portal whenever your team needs it for an FDA submission or inspection.
Can PharmaWatch monitor across multiple tissue bank locations?
Yes. The portal gives you a single view across every location — current storage status, excursion history, compliance records, and calibration documentation — regardless of how many sites you operate. Adding a new location requires no IT coordination. Drop in a sensor, plug it in, and it appears on your dashboard.
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