Cold chain monitoring built for regulated storage

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. Every alarm event carries its full trail, which severity fired, who was notified on which channel, who acknowledged and when, and that history cannot be edited after the fact, which is exactly what an auditor probes for. Access is scoped per person: alarm subscriptions are managed per user and per channel, and every account signs in with MFA or a magic link. We hold a SOC 2 Type II report, available under NDA, and we support customer-led IQ/OQ/PQ validation packages for regulated environments, with documentation to back the qualification effort.

Critical temperature excursions are delivered to on-call phones within seconds of the threshold breach. The edge gateway evaluates thresholds locally at the facility, so alarms fire even during a WAN outage, and the cloud fans the event out over SMS, email, and push in parallel rather than one channel at a time. Routing follows alarm groups: each excursion belongs to a group, each group enables its channels, and each person subscribes per channel, so the overnight QA contact gets SMS for critical freezers while a manager gets a daily email summary. Escalation paths re-page when an alarm goes unacknowledged. Acknowledgement is one tap on the native iOS or Android app, with full user attribution and timestamp logged for the audit trail, and the event history records the whole sequence from breach to resolution for every excursion.

Yes. Any dashboard in ControlCom Connect is also a PDF report: pick a date range, hit generate, and a rendered PDF covers every monitored asset, every reading, every excursion, and every acknowledgement in that window. Pre-built templates cover FDA, USP <797> / <800>, 21 CFR Part 11, and CDC VFC inspection formats, and scheduled monthly delivery sends the package to a QA distribution list automatically, so the routine record exists whether or not anyone remembers to run it. When a surveyor or a customer asks for the temperature history behind one unit or one week, the answer is a date-range query rather than a day spent reconstructing binders. Exports are also available as CSV and JSON for archival and quality systems that need the raw readings, and a report can be regenerated from stored data at any time.

In almost every case, yes. ControlCom Connect is vendor-neutral by design and onboards calibrated probes and dataloggers from any manufacturer over Modbus TCP/RTU, BACnet IP/MSTP, OPC UA, MQTT, SNMP, 4-20mA, RTD, thermocouple, and dry contact. That covers the usual mix in a regulated storage operation: laboratory-grade RTD probes in the ultra-low freezers, an OEM datalogger network in the warehouse, BMS points on the controlled-room-temperature areas, and door switches wired as dry contacts. You keep the calibrated sensor investment you already made, along with its calibration records; the platform adds the real-time alerting, tamper-evident audit trail, and reporting layer that the probes alone do not deliver. There is no per-tag licensing: plans are priced by data volume and device count, so monitoring every unit in the facility instead of a critical shortlist is an engineering decision within the allotment of your plan rather than a per-point purchase order.

The edge gateway is autonomous. It keeps reading sensors, evaluating thresholds, firing local alarms, and buffering data through any WAN or cloud incident, so a monitored freezer is never actually unmonitored just because the internet link dropped. When connectivity returns, buffered data backfills automatically with source timestamps preserved, so the audit record has no gaps and an excursion that happened mid-outage still appears at its true time with its full history. This is not a theoretical claim: during the October 2025 AWS outage the edge fleet ran autonomously for fifteen hours with zero data loss and zero manual intervention, and the records backfilled when the platform returned. For QA teams, the practical consequence is that the continuous temperature record your inspection depends on does not carry an asterisk for every network incident in the building.

A single-room or single-unit pilot is typically live within two to three weeks. Week one is discovery: we inventory the existing probes, dataloggers, and protocols, plus the alarm and reporting workflows your QA program requires, including who gets paged, in what order, and what the monthly package needs to contain. Week two is the edge install and configuration: thresholds per asset, severity tiers, escalation paths, dashboards, and report templates. From there the system runs in parallel with whatever you have today, chart recorders, OEM dataloggers, or a legacy monitoring service, so you evaluate ControlCom Connect against real excursions and real audit requests without any cutover risk to the existing program. Most QA teams start with the room that worries them most, prove the alert speed and record quality there, then expand across the facility and the network on their own schedule.