Real-time monitoring, audit-ready by design.
MySirius Monitoring is the software platform Qualified Controls deploys to keep regulated facilities continuously sensed, alerted, documented, and defensible — across every refrigerator, freezer, cleanroom, incubator, and storage suite under your charge.
units
alarms
One platform for every reading, every alert, and every record.
MySirius is the software layer that turns Qualified Controls' wireless sensors into an operational and regulatory system of record. Live dashboards, multi-channel alarms, structured escalations, signed acknowledgements, and on-demand reports — all delivered from the same audit-bound timeline.
It's not just a data-logger app. It is the compliance infrastructure that documents what was measured, who knew, what they did, and when — continuously, and on-demand.
What MySirius Does— end to end.
Nine capability pillars cover the full monitoring lifecycle: from the first sensor reading to the auditor's signature. Each pillar ships configured, validated, and documented as part of every Qualified Controls deployment.
Real-time dashboards & site mapping
Live tile, list, and floor-plan views of every monitored unit. Drill from facility → zone → asset in three clicks; pin critical assets, bookmark the views your team works from daily.
Multi-channel alarms & escalation
SMS, voice, email, and push — routed by severity, zone, time of day, and on-call schedule. Time-bound acknowledgement with automatic fallback to the next responder if no one answers.
Audit trail & 21 CFR Part 11 e-signatures
Every reading, alarm, acknowledgement, configuration change, and login captured with tamper-evident records, electronic signatures, and ALCOA+ data integrity controls baked in.
Automated reports & scheduled exports
One-click PDF/CSV exports for any asset, zone, or date range. Schedule weekly QA digests, monthly board reports, or full audit packages — emailed automatically to the right inbox.
Predictive service analytics
& Hot-Swap calibration
MySirius watches every asset's performance signature — drift, cycle behavior, recovery times — and surfaces equipment trending toward failure before it alarms. Recommended service is auto-routed to the right vendor; calibration cycles trigger pre-shipped Hot-Swap units with zero monitoring downtime.
See Hot-Swap Calibration →
Roles, permissions, SSO &
integrated training tools
Granular RBAC by site, zone, and capability. SAML / OIDC single sign-on with your IdP.
Read-only auditor accounts with one-click investigation views.
Built-in role-based training, with completion records that flow into the audit trail.
Mobile app & on-the-go acknowledge
iOS and Android apps with push-alarm, signed acknowledgement, and excursion-comment capture. Walk the floor, acknowledge from the cleanroom, attach a photo of the impacted asset.
Open API · LIMS · BMS · QMS
REST + webhook API, plus available integrations for LabWare, LabVantage, STARLIMS, Veeva, MasterControl, and major BMS platforms
(Siemens Desigo, JCI Metasys).
Validation package — IQ / OQ / PQ
Advanced + Enterprise deployments ship with executed installation, operational, and performance qualification protocols.
Mapping studies, traceability requirements, and change-control records included.
Hot-Swap Calibration. Zero monitoring downtime.
When a sensor's calibration cycle comes due, Qualified Controls pre-ships a duplicate, factory-calibrated unit to your facility. Your team performs a one-for-one swap. MySirius detects the exchange, retires the old certificate, attaches the new one, and updates the qualification record — automatically.
No service window. No paperwork race. No gap in your audit trail. The monitored asset never goes dark.
QC-NS-04812 calibrated 2026-04-21.Cert bound, tracking active.
NIST-2025-A77 retired. New cert NIST-2026-C19 attached to asset 0047.The diagnostic question your role keeps asking — answered.
Our monitoring platform is configured against the daily problems each role actually owns.
After-hours excursions you only learn about Monday morning
- BMS alarms route to a desk phone no one is sitting at.
- Excursion paperwork rebuilt from memory and email threads.
- No traceable acknowledgement chain when QA asks who responded.
- Replacing a sensor takes the unit offline for half a shift.
Continuous, escalating, and signed — without anyone touching a keyboard.
SMS → voice → on-call backup. Time-bound ack. No silent failures.
Excursion → ack → action → close, captured automatically.
Pre-calibrated replacements; zero downtime, full traceability.
24/7 monitoring response; QC stands between you and a pager.
Built on the architecture auditors expect.
Qualified Controls deploys monitoring for FDA-, USDA-, ISO 17025-regulated facilities, and more. Hosting, security, integrations, services and validation documentation are all part of the package.
Controls for regulated workflows.
Bring access, records, and validation into one coordinated review.
- ✓Customer data isolationCustomer-domain separation limits users to their own accounts and data.
- ✓Recorded activityUser actions and support interventions are recorded to support traceability.
- ✓Controlled infrastructure accessAdministrator multifactor authentication protects access to application servers and databases.
- ✓Validation & retentionReview electronic-record controls, audit trails, and retained information against your selected service level and intended use.
From sensor to system of record.
A connected stack engineered for regulated facilities — with the operational support to keep it running.
- ✓Wired & Wireless LoRa & Nano sensor familiesLong-range, multi-year battery, redundant data paths, cellular failover; deployed and validated by QC field engineers.
- ✓IQ / OQ / PQ packagedExecuted protocols, mapping studies, and traceability matrices delivered with every install.
- ✓Open REST + webhook APIOAuth-secured; bidirectional sync with LIMS, QMS, BMS, and data lakes.
- ✓SSO & identitySAML 2.0, OIDC, SCIM with Okta, Entra ID, Google, Ping, JumpCloud.
- ✓24/7 monitored responseQC's on-call support team backs your alarm tree; hot-swap calibration so monitoring never goes dark.
Confidence at every layer.
Your QC monitoring solution brings together quality-managed processes, secure cloud infrastructure, and independent security testing.
ISO 9001
Quality-managed development and service processes supported by ISO 9001:2015 certification within the solution ecosystem.
ISO 27001
Cloud infrastructure supported by ISO 27001 information-security controls, with layered physical and administrative safeguards.
SOC 2
Hosting controls supported by SOC assurance, providing a foundation for your supplier-security and cloud-risk review.
Penetration tested
Independent penetration testing evaluates the cloud solution against established security frameworks. No critical vulnerabilities were reported in the October 2025 test.
Protection beyond the credentials.
HTTPS access, customer data isolation, administrator multifactor authentication, recorded activity, continuous backups, and round-the-clock infrastructure monitoring support the operating environment.
Explore security review topics
- Access & accountability: customer-domain separation, controlled administrator access, and recorded user and support activity.
- Hosting & continuity: North American cloud hosting, a disaster-recovery environment, continuous backups, and infrastructure monitoring.
- Validation & records: review audit trails, retention, electronic-record controls, and validation scope for your selected plan.
- Independent assurance: review applicable certificates, hosting assurance, and penetration-test evidence against your supplier requirements.
Based on the cloud security policy (June 2024) and penetration-test declaration. Applicable scope and current evidence are confirmed during review.
Additional modules extend MySirius beyond the four walls.
Bolt-on capabilities for facilities whose monitoring obligations don't stop at the cleanroom door — each fully integrated into the same audit-bound timeline.
Cold Chain Logistics & Mobility
Extend continuous monitoring to product in transit. Track temperature and location from the moment a shipment leaves your dock to the moment it's received — with the same signed audit trail as fixed-site monitoring.
- In-transit data loggersGeo-fenced NIST-traceable wireless loggers ride with the shipment; data uploaded automatically on arrival.
- Per-shipment timelineOrigin, route, dwell, and excursion events on one timestamped record.
- Mobile receiving workflowReceiver scans, signs, and acknowledges — disposition decisions captured at the dock.
- Chain-of-custody & tamper alertsSame Part 11 audit fabric in transit as in your freezer — with instant alerts the moment a sealed shipment is opened off-route.
Mapping & Qualification Studies
Run formal thermal mapping and requalification studies inside the platform that already monitors the asset. Fewer tools, no spreadsheet wrangling, and a study report that drops directly into your validation package.
- Multi-point study runnerDeploy a sensor grid; run at-load, no-load, hot/cold-spot, and recovery studies.
- Auto-generated reportsMin/max/MKT statistics, gradient maps, deviation tables — in protocol-ready format.
- Tied to the assetMapping results live with the qualification record — not in a parallel filing system.
- Risk-based requalificationSchedule requal triggers; the platform knows when each asset is due.
Food Safety Checks
Replace clipboards with a mobile inspection workflow. Build HACCP and food-safety check routines, walk them on a phone or tablet, capture readings and photos at every CCP — all attached to the same continuous monitoring record.
- Configurable check routesBuild per-shift, per-line, or per-CCP rounds. Conditional logic for follow-up tasks.
- Delivery captureDelivery receipt readings, photos, signatures, and temperature acceptance.
- Corrective-action workflowOut-of-spec entries trigger CAPA records automatically; close-out signed.
- FSMA 204 + HACCP alignedRecords exportable in formats inspectors and major buyers expect.
Clean Room Intelligence
A full environmental monitoring system for classified space. Airborne particle counts, cascade differential pressure, temperature and humidity supervised continuously on one screen — with the open, wired architecture to reuse the instruments and PLCs you already own.
- Particle counting, automatedFixed or portable counters at 0.5 µm and 5 µm, ft³ or m³, sliding-window statistics, with start/stop and campaign import handled by the platform.
- Cascade pressure & airflowRoom-to-room ΔP hierarchies, temperature, humidity, and flow transmitters on Modbus RTU/TCP — 4 to 8 ΔP channels per cabinet, reusing existing tubing.
- Intelligent alarmingHigh-frequency acquisition with instant notifications and multi-colour signal-tower control, so the floor sees a deviation the moment it happens.
- Offline-safe by designThe on-site controller keeps logging and alarming through a network outage — zero data loss, full Part 11 audit trail on reconnection.
See where your monitoring program actually stands.
Answer a brief set of questions. Receive a preliminary REM maturity score, coverage-gap analysis, and a side-by-side of where MySirius would close the gaps in your current architecture.