01
01 / Detection pain
Excursions found on the morning round, not in the moment
Manual logging and nightly summary emails surface temperature excursions hours after they happened. By then, product is already at risk and the audit trail has a gap.
Real-time temperature visibility, immediate excursion alerts, and audit-ready compliance reports for pharmaceutical, vaccine, and biotech cold storage, across every facility you run, from one platform.
Cold chain monitoring on aging dataloggers and clipboards leaves QA teams chasing excursions after the fact, defending audit trails with spreadsheets, and writing off product they could have saved.
Manual logging and nightly summary emails surface temperature excursions hours after they happened. By then, product is already at risk and the audit trail has a gap.
FDA, USP <800>, and 21 CFR Part 11 expect a tamper-evident record of every excursion, every acknowledgement, and every corrective action. Spreadsheets and chart recorders cannot deliver it.
A single uncaught failure in a vaccine or biologic freezer can write off six figures of inventory. Insurance recovers some of it; the regulatory exposure is harder to recover.
OEM dataloggers and proprietary cloud portals lock cold storage data behind paywalls and per-export fees. Your QA team needs the data, not another login.
Cold chain monitoring for regulated industries where an undetected excursion is a board-level event.
Pharmaceutical distribution and 503B compounding: connect refrigerators, freezers, ultra-low freezers, and controlled-room-temperature storage across distribution centers and compounding suites. Per-asset thresholds, severity tiers, and escalation rules built around USP <797> / <800>, FDA, and DSCSA expectations. Audit-ready PDF logs delivered on a schedule your QA team controls.
Vaccine storage and CDC VFC programs: cold chain monitoring for vaccine storage units that meet CDC Vaccines for Children program documentation requirements. Continuous data logging, downloadable temperature logs, immediate SMS escalation on excursions, and a tamper-evident record the state immunization program can review on demand.
Biotech specimen and cell-therapy storage: high-stakes biotech inventory (patient-specific cell therapies, irreplaceable specimens, GMP raw material) needs more than a chart recorder. Real-time cold chain monitoring with redundant alerting, full audit trail, and a mobile on-call workflow so the right scientist is paged within seconds, not on the next round.
Six capabilities that turn a passive temperature record into an active compliance program.
Continuous readings from existing probes, dataloggers, and BMS points. Works with calibrated 4-20mA, RTD, thermocouple, Modbus, BACnet, and MQTT sensors. No rip-and-replace.
Per-asset thresholds, severity tiers, and escalation paths. Critical excursions hit on-call phones within seconds, with full acknowledgement workflow and user attribution.
Dashboard-as-PDF for any historical date range. Pre-built templates for FDA, USP <797> / <800>, 21 CFR Part 11, and CDC VFC inspections. Scheduled monthly delivery to your QA distribution list.
Portfolio view across every site, asset hierarchy by facility / room / unit, and benchmark dashboards that compare excursion rates and dwell-time across the network.
Catch slow drifts before they cross a threshold: door propped open, compressor degrading, defrost cycle out of spec. Trend-based events surface problems before product is lost.
Native iOS and Android apps with push notifications, MFA, and one-tap acknowledgement. On-call staff act on the alert from the parking lot, not after driving back to the workstation.
The four numbers QA leadership tracks, surfaced automatically from the data the platform is already collecting.
Adjacent pages for QA, compliance, and facilities leaders.
Refrigeration monitoring for food processing, cold storage warehouses, and refrigerated logistics.
Audit-ready exports, automated reports, and compliance evidence for FDA, USP, and 21 CFR Part 11 environments.
Dashboards, alarming, asset hierarchy, and edge SDK. The full ControlCom Connect platform.
Common questions from QA, compliance, and facilities leaders evaluating ControlCom Connect for cold chain monitoring.
ControlCom Connect implements the controls that 21 CFR Part 11 requires of an electronic record system: enforced MFA, role-based access control, tamper-evident audit logging on every user action and alarm event, time-stamped electronic signatures on acknowledgements, and AES-256 encryption at rest with TLS 1.3 in transit. SOC 2 Type II is in progress and the report is available under NDA. We support customer-led IQ/OQ/PQ validation packages for regulated environments.
Pick a single cold storage room or unit. We onboard your existing calibrated sensors, configure the alarms and reports your QA team needs, and run alongside your current system for ninety days. No rip-and-replace. No cutover risk. Expand on your schedule.