Why Organizations Choose ATEK Over SmartSense by Digi
When Digi International acquired Jolt Software for $145.5 million in August 2025, it signaled where SmartSense by Digi is heading: deeper into retail operations management with digital task workflows and employee scheduling, not into pharmaceutical manufacturing compliance. For organizations in regulated pharmaceutical manufacturing, biotech, hospital pharmacies, and life sciences, this trajectory raises an important question: is a platform optimized for CVS refrigerator compliance the right foundation for FDA 21 CFR Part 11 monitoring?
Understanding SmartSense by Digi
Founded in 2005 and headquartered in Scottsdale, Arizona, USA, SmartSense is a division of Digi International Inc. (NASDAQ: DGII), a company with $105M Q2 2025 revenue and $123M record ARR. SmartSense serves 38,000+ enterprise sites worldwide, with key customers including CVS Pharmacies, Kroger Health (2,200 pharmacies, 200 clinics), Walmart, Sweetgreen, Jollibee, and Wolfgang Puck.
Their key offerings include:
- SmartSense wireless monitoring platform for retail pharmacy and foodservice
- NIST-calibrated wireless sensors, battery-powered and wire-free
- Retail pharmacy compliance: CDC, VFC, FDA, state pharmacy boards
- In August 2025, acquired Jolt Software for enhanced digital task workflows and employee scheduling
- New VOYAGE T1: GPS-enabled, cellular, temperature monitoring for in-transit supply chain tracking
SmartSense’s recognized strengths include:
- Retail Pharmacy Scale — 38,000+ enterprise sites including national pharmacy chains (CVS, Kroger Health, Walmart) with proven retail compliance expertise.
- Multi-Location Platform — Strong capabilities for managing sensors across hundreds of retail pharmacy locations and foodservice operations.
- Digi International Resources — Backed by NASDAQ-listed Digi International with enterprise-scale infrastructure and significant financial resources.
Common Challenges with SmartSense by Digi
Organizations evaluating or currently using SmartSense for pharmaceutical manufacturing or life sciences frequently encounter these critical gaps:
- Not Built for 21 CFR Part 11: SmartSense targets retail pharmacy compliance (CDC/VFC), not FDA 21 CFR Part 11 for pharmaceutical manufacturing and life sciences.
- Business Hours Support Only: Standard business hours support means no live response when a biotech incubator hits a critical temperature excursion at 2 AM — exactly when regulated facilities need immediate intervention most.
- No A2LA-Accredited Calibration: Only third-party NIST calibration available; no in-house accredited lab means customs delays and additional costs.
- Canadian Data & Regulatory Gap: No Canadian data hosting, no bilingual support, no Health Canada regulatory expertise—problematic for Canadian manufacturers.
- Wrong Market Fit: Platform designed for retail refrigerators, not hospital pharmacies, pharmaceutical manufacturing, biotech facilities, or cleanrooms.
How ATEK Addresses These Needs
ATEK’s approach centers on full pharmaceutical manufacturing compliance, 5-minute phone guarantee, A2LA-accredited in-house lab, and life sciences focus, delivering measurable improvements across critical operational areas:
Full FDA 21 CFR Part 11 Compliance, Not Partial: ATEK’s platform is natively built for FDA 21 CFR Part 11 with electronic signatures, complete audit trails (ALCOA+), and validation documentation included by default. SmartSense’s partial implementation is designed for retail pharmacy boards, not life sciences regulators. Organizations managing pharmaceutical monitoring need comprehensive compliance, not retail-grade approximations.
24/7 Live Support with 5-Minute Response: When a critical excursion occurs at 2 AM, ATEK’s Montreal-based team answers the phone—guaranteed. No automated phone systems, no ticket queues, no next-business-day callbacks. Bilingual support in English and French.
A2LA-Accredited Calibration Lab In-House: ATEK’s in-house A2LA-accredited calibration lab (ISO 17025) handles calibration, certificates, and traceability documentation in one place. SmartSense relies on third-party calibration with custom delays and additional costs. ATEK calibration is included in your monitoring pricing.
Real-Time Monitoring: 30-second data updates provide continuous visibility into your environment. Six months of local data storage ensures zero data loss during network outages.
All-Inclusive Pricing: Per-monitoring-point pricing with unlimited users, sites, and training included. No surprise license fees, add-on costs, or annual escalations.
Canadian Data Hosting & Regulatory Expertise: ATEK is based in Quebec with Canadian data centers. Full PIPEDA, FIPPA, and provincial privacy compliance with dedicated Health Canada regulatory knowledge.
Side-by-Side Comparison
| Factor | SmartSense | ATEK | Advantage |
|---|---|---|---|
| Retail pharmacy scale | 38,000+ sites (CVS, Kroger) | Growing | SmartSense |
| Multi-location retail management | Purpose-built for 1000s of sites | Enterprise-capable | SmartSense |
| Parent company resources | Digi International (NASDAQ: DGII) | Monitoring-focused | SmartSense |
| FDA 21 CFR Part 11 | Partial (retail focus) | Full native compliance | ATEK |
| Support response | Business hours | 5-minute guarantee, 24/7 | ATEK |
| A2LA calibration | Third-party NIST | In-house A2LA-accredited | ATEK |
| Canadian presence | Limited | Quebec-based, bilingual | ATEK |
| IQ/OQ/PQ documentation | Not provided | Included | ATEK |
| Cloud platform | SmartSense Cloud | ATEK Cloud | Comparable |
The Key Difference: Retail vs. Pharma Manufacturing
SmartSense by Digi is intentionally optimized for retail pharmacy compliance (CDC, VFC, state pharmacy board requirements for retail refrigerators). Their market includes CVS, Kroger Health, and foodservice chains.
ATEK is purpose-built for pharmaceutical manufacturing and life sciences (FDA 21 CFR Part 11, hospital pharmacies, biotech incubators, cleanrooms, and lab environments).
This isn’t a minor difference—it’s the fundamental design choice of each platform. SmartSense’s “partial” 21 CFR Part 11 implementation means their electronic signatures, audit trails, and validation workflows are sufficient for retail pharmacy boards but insufficient for FDA life sciences audits.
Who Benefits Most from Switching
Organizations in these situations see the greatest impact when moving to ATEK:
- Pharmaceutical manufacturing facilities
- Hospital pharmacy systems
- Biotech and life sciences research labs
- Cleanroom and controlled environment monitoring
- Organizations requiring 24/7 support for critical GxP operations
- Canadian companies needing bilingual support and local regulatory expertise
- Facilities requiring A2LA-accredited calibration without customs delays
Making the Transition
Switching from SmartSense by Digi to ATEK is designed to be straightforward with zero compliance gaps:
- Assessment — We evaluate your current monitoring setup, compliance requirements (21 CFR Part 11, Health Canada, validation scope), and integration needs
- Parallel deployment — ATEK sensors operate alongside existing SmartSense equipment during the validation period
- Validation — Complete IQ/OQ/PQ documentation included at no additional cost; full FDA/Health Canada validation package included
- Go-live — Seamless cutover with ongoing training and 24/7 support from day one
When SmartSense by Digi May Be the Right Fit
SmartSense by Digi can be appropriate for organizations that prioritize:
- National retail pharmacy chain compliance (CDC/VFC)
- Multi-location foodservice or retail monitoring
- Cost-optimized pricing for high-volume, low-margin retail environments
- Integration with Digi International ecosystem products
SmartSense is not appropriate if you require FDA 21 CFR Part 11 compliance, 24/7 support, A2LA-accredited calibration, bilingual support, or Canadian data hosting.
When ATEK Is the Better Choice
Choose ATEK when you need:
- FDA 21 CFR Part 11 Compliance — Full native compliance, not partial; electronic signatures, audit trails, validation included
- 24/7 Live Phone Support — 5-minute response guarantee with bilingual Montreal-based team
- A2LA-Accredited Calibration — In-house lab, NIST-traceable, no customs delays, included in pricing
- Canadian Data & Regulatory Expertise — Quebec-based operations, PIPEDA/FIPPA compliance, Health Canada knowledge
- Pharmaceutical Manufacturing Focus — Purpose-built for biotech, hospital pharmacies, cleanrooms, and life sciences
- All-Inclusive Pricing — No hidden fees, no surprise license escalations, unlimited users and sites
Frequently Asked Questions
Q: Is SmartSense by Digi suitable for pharmaceutical manufacturing?
A: No. SmartSense is explicitly designed for retail pharmacy chains and foodservice operations. Their platform targets CDC/VFC compliance for retail refrigerators and food safety labeling (especially with their Jolt acquisition). Pharmaceutical manufacturing requires FDA 21 CFR Part 11 compliance, and SmartSense’s partial implementation is not suitable. ATEK is purpose-built for pharmaceutical manufacturing with native 21 CFR Part 11 compliance.
Q: What does “partial 21 CFR Part 11” mean for SmartSense?
A: SmartSense offers basic compliance features like electronic signatures and some audit logging, but their platform wasn’t architected from the ground up for FDA life sciences audits. Their electronic signature workflows, audit trail completeness, and validation documentation are designed to satisfy retail pharmacy board inspections, not FDA investigator audits. ATEK’s 21 CFR Part 11 implementation is comprehensive and ALCOA+ compliant, built specifically for life sciences regulators.
Q: Does SmartSense have 24/7 support?
A: No. SmartSense operates a standard business hours support model. For critical excursions at 2 AM or on weekends, you’ll reach voicemail or automated systems. ATEK provides 24/7 live phone support with a 5-minute response guarantee, staffed by a dedicated Montreal-based team.
Q: Can SmartSense handle US pharmaceutical manufacturers with Canadian facilities?
A: SmartSense provides no Canadian data hosting, bilingual support, or Health Canada regulatory expertise. If you operate across the US-Canada border, SmartSense can’t meet your Canadian requirements. ATEK offers Quebec-based data hosting, bilingual English/French support, and dedicated Health Canada compliance knowledge.
Q: What about SmartSense by Digi’s new VOYAGE T1 product?
A: VOYAGE T1 (launched January 2025) is a GPS-enabled cellular sensor for in-transit supply chain tracking with temperature monitoring. It’s designed for retail foodservice and pharmacy delivery operations—further confirming SmartSense’s retail focus. For pharmaceutical manufacturing and life sciences operations requiring stationary environmental monitoring in regulated facilities, ATEK is the appropriate choice.
Q: How does calibration differ between SmartSense and ATEK?
A: SmartSense uses NIST-calibrated sensors but relies on third-party calibration services, meaning custom delays, additional costs, and no integrated certificate management. ATEK maintains an A2LA-accredited (ISO 17025) calibration laboratory in-house, providing NIST-traceable certificates, zero customs delays, and calibration included in your monitoring pricing. For pharmaceutical operations, in-house A2LA accreditation is a significant advantage during regulatory audits.
Start with a free compliance assessment to see how ATEK’s purpose-built platform compares to SmartSense for your pharmaceutical or life sciences monitoring requirements.