Temperature Monitoring
A 21 CFR Part 11 validated, USP 797/800-ready temperature and environmental monitoring platform — to VA medical centers, hospital pharmacies, clinical laboratories, and pharmaceutical facilities across North America. Purpose-built for regulated environments.
Purpose-built for regulated environments. Backed by a Service-Disabled Veteran-Owned small business that understands mission-critical compliance.
SDVOSB Certified
A partnership built to support the VA and DoD contractors.
21 CFR Part 11 Validated
MySirius carries formal FAT qualification reports across every release
ISO 17025 Calibration
NIST-traceable calibration certificates — a procurement checklist item for hospital pharmacies and A2LA-accredited labs
IQ/OQ/PQ Documentation Available
Version-specific validation packages reduce your validation burden from months to days
Cloud + Server Deployment
Full compliance feature parity across both editions — validated independently (VALID24001)
North America Service Footprint
Monitoring, service, and support for VA medical centers and healthcare systems across the US and Canada
Comprehensive Coverage:
Regional deployment teams coordinate installation and validation across your facilities
Local service technicians provide on-site support for equipment calibration and troubleshooting
Technical support specialists deliver expert guidance during critical compliance events
Account managers understand your industry’s regulatory landscape and operational challenges
Whether you’re validating a new cleanroom in California or troubleshooting an alert in Massachusetts, JRI’s North American presence ensures you’re never waiting for support from distant time zones. Our teams understand regional regulatory nuances and can coordinate multi-site deployments with precision.
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The essential compliance platform engineered for highly regulated environments to protect critical assets and streamline manual processes
How it works:
Full on-premises deployment with 100% feature parity to cloud
ISO 27001 + 21 CFR Part 11 + GMP/GxP compliant either way
Open Web API for third-party system integration — native, documented
Multi-point analysis identifies hot spots, cold spots, and temperature gradients that could impact product quality
This capability transforms temperature mapping from an expensive, periodic compliance exercise into a strategic quality tool that strengthens your understanding of environmental conditions and supports continuous improvement.
Continuous Monitoring &
Real-Time Alerts
Know the moment a temperature threshold is breached — before product is compromised, before staff arrive in the morning, and before an inspector asks why you didn't know.
Visiblity + Fleixibility = Your Compliance and Asset Protection Platform
Liberty SPY, Nova SPY, LoRaSPY, and LoRaWAN sensors — temperature, humidity, CO₂, differential pressure
Multi-level alert cascade: threshold alarms → pre-alarms → escalating SMS, email, voice call, light bar, buzzer, relay output
Configurable escalation delays (0, 2h, 6h, 12h, 24h, 48h, 72h) with delegation management for holidays and absences
MySiriusAlert mobile app — real-time visibility and alarm acknowledgment from any location
Auto-restart on sensor interruption; up to 3 automatic measurement recovery retries (LoRa); missing measurements flagged — never silently dropped
Engineered for Compliance
Engineered, deployed and supported to meet the strictest compliance standards
21 CFR Part 11
Electronic records, electronic signatures, audit trails — MySirius functions My303–My308 (e-signatures, audit trail, missing measurement management) are FAT-tested across every release
USP 797 / USP 800
Environmental monitoring response requirements for compounding pharmacies — multi-level alert cascades with configurable escalation (0–72h delays) ensure no overnight excursion goes undetected
ISO 17025 / A2LA
Calibration traceability and TUR calculation — MySirius Calibration Module generates CE/CV reports, performs drift analysis, and calculates TUR natively without a separate LIMS
EU GMP Annex 11
Computerized system validation for pharma manufacturers — MySirius VALID-series qualification reports support Annex 11 mapping for dual FDA/EU regulated facilities
CLIA / CAP
Lab quality and proficiency requirements — unified monitoring and calibration records across all instrumentation from one platform
VA/DoD Environmental Standards
Asset protection and chain-of-custody documentation for federal pharmacy and lab environments — tamper-proof audit trail with role-based access control and electronic signature finalization
Audit Trail & Data Integrity
When the inspector arrives — announced or unannounced — pull 18 months of tamper-proof temperature records in under two minutes.
Time-stamped, immutable audit trail for every sensor reading, alarm acknowledgment, configuration change, and calibration event
Electronic signatures (My303–My305) and audit trail functions (My306a–My306b) FAT-tested across all MySirius releases
Automated scheduled reports; intervention reports; one-click historical data export for any inspection window
Pharmaceutical data export (My469–My471) importable into Metrolog and QMS platforms
Role-based access control with configurable user permission levels — satisfies 21 CFR Part 11 Subpart C and VA IT security requirements
Why Mitchell, Knox & Lincoln?
Mitchell, Knox & Lincoln enhances the Maintenance Module by aligning it with government procurement processes and operational realities.
Their services include:
- Custom system configuration
- Integration with existing infrastructure
- Training and onboarding
- Ongoing technical support
This ensures that organizations can implement and scale the solution effectively.
Business Value
Organizations adopting the Maintenance Module achieve:
Reduced downtime and operational disruptions
Lower maintenance costs
Improved compliance and audit readiness
Increased system reliability
For government entities, this translates into better performance, reduced risk, and stronger accountability.
The Maintenance Module is essential for organizations that depend on reliable monitoring systems. Through Mitchell, Knox & Lincoln, it becomes a fully supported, government-ready solution that ensures operational continuity, compliance, and long-term efficiency.
How do I know this is actually Part 11 compliant?
MySirius carries a formal FAT qualification report for every release from v4.1.4 through v5.1.6, with function-by-function conformity test results. Report numbers are visible and downloadable.
What happens if the network goes down?
Sensors store measurements locally during any outage. On reconnection, automatic recovery runs up to 3 retries. Missing measurements are flagged in the audit trail — never silently dropped. Your compliance record stays complete through infrastructure incidents.
We need calibration management too — is that a separate system?
Calibration is built natively into MySirius. Generate CE/CV reports, perform drift analysis, manage TUR, and maintain full probe history — all within the same platform. No separate LIMS or integration required.
What if our IT department won't approve a new cloud vendor
Deploy the Server edition within your own infrastructure. For Cloud deployments, MySirius communicates exclusively over HTTPS with certificate-based device authentication to a single endpoint — whitelistable in minutes.
Is this solution cost-justified for our facility?
A single prevented temperature excursion in a specialty pharmacy or VA research lab recovers $50K–$500K+ in product loss. MySirius is not a monitoring expense — it is asset protection and compliance infrastructure.
IT & Cloud Modernization
Trusted by the government and private organizations to streamline operations and drive efficiency
Our Services
Temperature Monitoring
Envrionmental Monitoring
Telematics and Fleet Tracking
Vehicle Safety Cameras
FMIS Fleet Managmenet Solution
Communications & Marketing
Foodcheck
Maintenance
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