Why Organizations Choose ATEK Over TSS
TSS (Temperature Sensitive Solutions) was founded in 1992 to solve a specific problem: how to validate thermal environments in pharmaceutical cleanrooms and cold storage facilities with rigor and documentation. For three decades, the company has built a reputation around thermal mapping expertise and validation protocols. But TSS answers a different question than most organizations ask today.
TSS asks: “How do we prove our environment meets specifications during this audit window?”
Modern pharmaceutical operations ask: “How do we know our environment is safe right now — and prove it later?”
These questions define a fundamental difference between periodic validation and continuous monitoring. Understanding this distinction helps organizations choose the right partner for their actual compliance needs.
Understanding TSS
TSS AB was founded in Mölndal, Sweden (near Gothenburg) in 1992 and has operated as a private Swedish company ever since. The company specializes in thermal mapping services — the practice of measuring temperature distribution across a defined space (a cleanroom, cold storage facility, or pharmaceutical manufacturing suite) using multiple sensors positioned at critical locations. Once the map is complete, TSS provides documentation that validates the space meets pharmaceutical specifications at the moment of testing.
TSS also operates a GxP-compliant SaaS documentation platform that organizations use to archive mapping results, store validation records, and maintain the audit trail required for FDA 21 CFR Part 11 and EU GMP Annex 11 compliance.
TSS’s recognized strengths include:
- Thermal Mapping Expertise — Three decades of experience designing thermal mapping studies, selecting sensor placement, conducting measurements, and interpreting results according to EU GMP and pharmaceutical industry standards. The company understands the physics of temperature distribution and the regulatory requirements for proving it.
- GxP Documentation Platform — A cloud-based system purpose-built for storing validation records with electronic signature support, audit trails, and role-based access control. The platform is designed specifically for pharmaceutical compliance workflows.
- Established European Relationships — Strong customer base across European pharmaceutical facilities, with proven track record in cleanroom qualification and validation audit protocols. The company’s understanding of European facility requirements is comprehensive.
Common Challenges with TSS
Organizations evaluating or currently using TSS frequently encounter these considerations:
- Periodic audits miss real-world problems: A thermal mapping study captures a snapshot of your environment on the day the study is performed. Cleanroom HVAC failures, sensor drift, or thermal gradients that develop between audits remain invisible until the next audit cycle — sometimes months later. By then, product batches have already been manufactured under the unknown conditions.
- Support is not available when excursions occur: TSS is based in Stockholm, creating a 6-9 hour time zone gap from North American facilities. When a temperature excursion is detected at 2 AM Eastern in a Canadian pharmaceutical plant, the TSS support team is asleep. Organizations must maintain separate monitoring systems and escalation procedures to handle real-time alerts, adding complexity and cost.
- Data residency and PIPEDA compliance questions: Validation records and monitoring data stored on European servers raise questions about Canadian data sovereignty, PIPEDA compliance, and privacy obligations for Quebec facilities. Organizations often need clarification on where their temperature data physically resides.
- Hardware and calibration logistics from Europe: Sensors and equipment typically ship from Sweden, creating 2-4 week lead times and customs considerations. Calibration services may require returning equipment to Europe or coordinating with European-based calibration partners, extending turnaround times and delaying facility readiness.
- Finger-pointing risks in multi-vendor scenarios: TSS mapping services often require coordination with separate hardware providers, system integrators, and calibration vendors. When a sensor fails or data is lost, it’s unclear who is responsible for diagnosis and resolution. Understanding FDA 21 CFR Part 11 compliance requirements helps clarify where responsibility should lie for regulatory documentation.
How ATEK Addresses These Needs
Continuous 24/7 Monitoring vs. Periodic Snapshots: TSS captures your environment at specific moments in time. ATEK monitors it continuously with 30-second data updates, 24 hours a day, 365 days a year. You see temperature trends, catch excursions the moment they happen, and have historical data to prove your environment was compliant throughout the critical period — not just on audit day. Organizations migrating from TSS gain visibility into environmental behavior they never had before, including drift trends and seasonal variations that wouldn’t appear in a single mapping study.
Single Vendor, Complete Accountability: Where TSS requires you to coordinate with separate mapping services, hardware vendors, and calibration services, ATEK is one contact. Hardware, monitoring platform, 24/7 support, calibration, validation documentation, and training all come from ATEK. When something needs attention, you have one number to call and one vendor accountable for the solution. This simplicity eliminates the finger-pointing that occurs when a problem could belong to the sensor, the integration, or the third-party calibration service.
North American Support at Your Timezone: ATEK’s Montreal-based team is available when problems occur in North American facilities. Temperature excursions at 2 AM Eastern mean a live environmental monitoring specialist answers the phone in minutes, not after Scandinavian business hours resume. For Canadian facilities, bilingual support (English and French) is native — not a translation layer — and our team understands Health Canada requirements and Quebec regulations directly. Visit our pharmaceutical monitoring platform to see how this localized expertise translates to better outcomes.
A2LA-Accredited Calibration Without Cross-Border Delays: ATEK’s in-house calibration lab is A2LA-accredited and located in Canada. Your sensors are calibrated, documented with NIST-traceable certificates, and returned to service within days — not weeks waiting for European turnaround or navigating customs. For Canadian facilities, this means no cross-border shipping, no customs holds, and no coordination with third-party labs. Calibration happens locally at a cost that’s included in your ATEK pricing, not as a separate engagement.
Side-by-Side Comparison
| Factor | TSS | ATEK | Advantage |
|---|---|---|---|
| Monitoring frequency | Annual/quarterly audits | 30-second continuous | ATEK |
| Real-time alerting | No (requires separate system) | 24/7 built-in | ATEK |
| Thermal mapping expertise | Specialized | Included in validation | TSS |
| Time zone support | Stockholm (6-9 hour gap) | Montreal (local) | ATEK |
| North American presence | Limited | Direct local operations | ATEK |
| Calibration | Third-party European | A2LA in-house Canadian | ATEK |
| FDA 21 CFR Part 11 | Available | Native | Comparable |
| Single vendor accountability | No (multi-vendor) | Yes | ATEK |
| Bilingual support | No | Montreal native EN/FR | ATEK |
| Data residency (PIPEDA) | European servers | Canadian servers | ATEK |
Who Benefits Most from Switching
- Pharmaceutical manufacturers with facilities in Canada or North America currently relying on annual or semi-annual TSS thermal mapping audits, who need continuous real-time visibility and 24/7 local support for regulatory compliance and operational safety
- Cold storage and cleanroom operators frustrated by the months-long periods between TSS audit cycles, wanting to know about temperature drift or HVAC failures the moment they occur rather than discovering them weeks later during the next validation
- Multi-facility organizations using TSS for mapping services at some locations while maintaining separate continuous monitoring systems at others, looking to consolidate on a single integrated platform with local support
Making the Transition
Switching from TSS’s periodic validation model to ATEK’s continuous monitoring requires a different approach than traditional vendor migration, since you’re adopting real-time monitoring rather than replacing it:
- Facility assessment — We identify all critical monitoring points from your most recent TSS thermal mapping study, including sensor placement locations, temperature control zones, and compliance requirements. We incorporate TSS’s mapping expertise into our permanent monitoring point placement.
- Baseline deployment — ATEK wireless sensors install at the locations TSS identified as critical, plus additional points recommended for continuous 24/7 visibility. Unlike mapping (which happens once), our baseline deployment captures your environment’s actual behavior over 2-4 weeks, revealing seasonal trends, diurnal variations, and edge cases that a single audit would miss.
- Validation and handoff — TSS mapping data becomes your historical baseline. ATEK provides complete IQ/OQ/PQ documentation proving that continuous monitoring at these points meets your facility’s compliance obligations. Your team transitions from “we’ll know status at audit time” to “we know status right now.”
- Continuous operation — ATEK’s 24/7 monitoring and 5-minute support guarantee become your new operational baseline. Thermal mapping (if required for regulatory reasons) becomes an occasional verification activity, not your primary compliance mechanism.
When TSS May Be the Right Fit
TSS is appropriate for organizations with occasional, well-defined thermal validation needs — facilities that are confident their HVAC and temperature control systems work correctly and only need periodic documentation to prove it. Organizations in stable, controlled environments with minimal thermal risk may not benefit from the expense of continuous monitoring. TSS’s expertise in thermal physics and Scandinavian regulatory experience is genuinely valuable for organizations needing specialized mapping or for facilities in European markets where TSS’s local relationships provide advantages.
When ATEK Is the Better Choice
Choose ATEK when you need:
- Real-time temperature monitoring 24/7 instead of periodic audits, giving you immediate visibility into environmental conditions and catching excursions the moment they occur
- Local North American support with guaranteed 5-minute response, not Stockholm-based business hours support with time zone delays
- Canadian data hosting and PIPEDA compliance for facilities requiring domestic data residency and provincial privacy compliance
- In-house A2LA calibration without cross-border shipping, customs delays, or third-party coordination
- Single vendor accountability for monitoring, alerting, documentation, and support — no finger-pointing across multiple providers
- Bilingual support from our Montreal team, understanding both Health Canada and Quebec regulatory requirements natively
Organizations moving from periodic validation to continuous monitoring typically report a shift in how they think about facility compliance. Instead of proving “we were safe during the audit window,” they start proving “we’ve maintained safe conditions throughout every minute of operation.” This shift requires a continuous monitoring partner, not a periodic audit vendor. Start with a free assessment to understand how ATEK’s continuous approach applies to your specific facility monitoring requirements.
Frequently Asked Questions
Can ATEK replace TSS thermal mapping audits?
ATEK’s continuous monitoring provides real-time visibility that complements thermal mapping. Our baseline deployment captures your environment over 2-4 weeks, revealing actual temperature behavior and drift that a single audit snapshot might miss. For regulatory purposes, thermal mapping is sometimes required as a baseline documentation step. ATEK works with your existing TSS mapping records or can coordinate with independent thermal mapping services if additional validation is needed. The key difference: mapping proves “the environment met specs on this date.” Continuous monitoring proves “the environment has met specs every day since installation.”
Is ATEK’s 24/7 monitoring FDA 21 CFR Part 11 compliant like TSS?
Yes. ATEK’s platform provides native FDA 21 CFR Part 11 compliance including electronic signatures, complete audit trails, and ALCOA+ data integrity. Unlike TSS, which focuses on documentation of validation events, ATEK’s compliance is built into continuous monitoring and alerting. Every data point is signed, timestamped, and auditable from the moment it’s recorded.
How long does it take to switch from TSS to ATEK?
Unlike switching from another continuous monitoring platform, moving from TSS’s periodic model to ATEK involves establishing new baselines rather than migrating data. Initial deployment typically takes 1-2 weeks depending on facility size and complexity. Your most recent TSS thermal mapping study becomes your installation guide — we place continuous sensors at the critical points TSS identified, then expand with additional monitoring for 24/7 visibility. You’re operational and in compliance from day one of deployment.
What happens to the validation records and mapping data from TSS?
TSS’s mapping documentation becomes your historical baseline and proof of prior compliance. ATEK’s IQ/OQ/PQ documentation demonstrates that continuous monitoring meets your facility’s compliance requirements going forward. We assist with data retention planning to ensure your compliance archive needs are met. During the parallel operation period (if you maintain TSS services during transition), both the TSS platform and ATEK system operate simultaneously, providing redundant documentation.
Does ATEK support the same GxP documentation that TSS provides?
ATEK provides FDA 21 CFR Part 11 and EU GMP Annex 11 compliant documentation including electronic signatures, audit trails, and automated compliance reporting — the same standards TSS uses. The difference is scope: TSS focuses on documenting specific validation events, while ATEK documents continuous compliance across every minute of operation. Organizations often keep TSS for occasional thermal mapping (if required) and use ATEK for day-to-day monitoring and compliance proof.
Does ATEK offer bilingual support like some European vendors?
Yes. ATEK’s Montreal-based team provides native bilingual support in English and French, understanding Quebec regulations and Health Canada requirements directly. TSS’s bilingual capabilities, if available, are typically accommodation translations rather than native support. This matters when regulatory questions arise at 3 AM during a facility crisis — a native-speaking team familiar with provincial requirements outperforms translation services every time.
Why should we move from scheduled validation to continuous monitoring?
Thermal mapping answers the question “Did we meet specs during the audit window?” Continuous monitoring answers “Do we meet specs right now, and did we meet them yesterday, and the day before?” Regulatory bodies increasingly expect the second answer. Continuous data is also more defensible than periodic audits in product recalls or quality investigations — you have complete historical evidence of conditions rather than periodic snapshots. Organizations also discover problems faster: HVAC failures, sensor drift, or calibration drift are caught immediately, not weeks later at the next audit.