Why Organizations Choose ATEK Over Ellab
Since 1949, Ellab has built an unrivaled reputation in one very specific discipline: thermal validation for pharmaceutical manufacturing. ValSuite Pro is the software that validation engineers reach for when qualifying autoclaves, freeze-dryers, and sterilizers. When Novo Holdings — the investment arm of the Novo Nordisk Foundation — acquired Ellab, it cemented the company’s position within the world’s deepest life sciences investment ecosystem. But validation and continuous environmental monitoring are fundamentally different disciplines. Organizations that need 24/7 real-time monitoring of cleanrooms, stability chambers, and cold storage face a critical question: should they extend a validation-first platform into monitoring, or choose a purpose-built monitoring solution?
Understanding Ellab
Ellab A/S was founded in 1949 in Hilleroed, Denmark, making it one of the oldest companies in pharmaceutical process validation. The company’s core expertise lies in thermal validation — qualifying that autoclaves reach proper sterilization temperatures, that freeze-dryers maintain consistent shelf temperatures, and that depyrogenation tunnels achieve required heat levels. ValSuite Pro, their flagship validation software, manages data from TrackSense Pro wireless loggers and E-Val Pro wireless validation systems during qualification studies.
Ellab’s monitoring offering, the SKY system, provides continuous environmental monitoring for GxP-regulated spaces. However, SKY was developed as an extension of a validation company’s portfolio, not as the company’s primary product focus. Ellab operates global offices including a US presence in Houston, TX, and maintains DAkkS (German) and DANAK (Danish) accredited calibration laboratories.
Ellab’s recognized strengths include:
- Thermal Validation Gold Standard — ValSuite Pro is the reference point for pharmaceutical process validation, used by validation teams worldwide to qualify autoclaves, freeze-dryers, sterilizers, and depyrogenation tunnels with unmatched protocol depth and regulatory acceptance
- Novo Holdings Ownership — Acquisition by Novo Holdings (Novo Nordisk Foundation) places Ellab within a pharma-focused investment ecosystem managing over $100 billion in assets, ensuring long-term stability and alignment with pharmaceutical industry needs
- DANAK/DAkkS Calibration Heritage — Accredited European calibration laboratories with deep traceability expertise in temperature, humidity, and pressure measurement — particularly strong for validation instrument calibration where demanding uncertainty requirements apply
Common Challenges with Ellab
Organizations evaluating or currently using Ellab frequently encounter these considerations:
- Monitoring as an afterthought: Ellab’s SKY continuous monitoring system exists alongside — not integrated with — ValSuite Pro validation software. Organizations end up managing two separate software platforms, two data repositories, and two sets of user credentials for what should be a unified compliance workflow
- Product portfolio complexity: Selecting between TrackSense Pro, E-Val Pro, SKY wireless sensors, and multiple logger families requires significant upfront evaluation. Each product line has different software requirements, different connectivity options, and different use cases, creating procurement confusion
- European time zone support gap: Ellab’s headquarters in Hilleroed, Denmark (CET/CEST) means that after-hours environmental monitoring incidents at North American facilities — the 2 AM stability chamber excursion — are occurring when the primary technical team is unavailable or just arriving at their desks
- Enterprise cost structure: Full engagement with Ellab often means licensing ValSuite Pro, purchasing SKY monitoring hardware and software, engaging calibration services, and contracting professional validation consulting — each as separate budget items with separate negotiation cycles
- Cross-border calibration logistics: While Ellab’s DANAK/DAkkS-accredited labs serve European facilities efficiently, Canadian organizations face international shipping, customs clearance, and multi-week turnaround when sending instruments to European calibration facilities
How ATEK Addresses These Needs
Purpose-Built Continuous Monitoring: Ellab added monitoring to a validation platform. ATEK built its entire platform around 24/7 continuous environmental monitoring for regulated spaces. Every feature — real-time alerts with 30-second data intervals, cloud-native architecture, integrated compliance documentation — was designed for the specific demands of monitoring pharmaceutical cleanrooms, stability chambers, and cold storage. Organizations get a platform where monitoring is the primary capability, not a secondary product line.
24/7 Live Support from Montreal: When Ellab’s Danish headquarters is at 8 AM CET, it is 2 AM Eastern — exactly when environmental excursions create the most risk at North American facilities. ATEK’s Montreal-based monitoring team provides guaranteed 5-minute live response around the clock. The team handles environmental monitoring exclusively and offers native French-English bilingual support for Quebec pharmaceutical facilities, something Ellab’s European-based team cannot match.
A2LA-Accredited Calibration Without Borders: Ellab’s DANAK and DAkkS calibration accreditations are internationally recognized and well-regarded for validation instruments in European facilities. For Canadian organizations, ATEK’s in-house A2LA-accredited calibration lab provides local service without international shipping, customs paperwork, or multi-week turnaround delays. Both hold internationally recognized accreditation — the advantage is logistics, not quality.
One Price for Monitoring, Not Component Billing: Ellab’s enterprise model prices ValSuite Pro licensing, SKY monitoring hardware and software, data loggers, calibration services, and professional consulting as separate engagements. ATEK’s all-inclusive per-monitoring-point rate bundles hardware, cloud platform, calibration, validation documentation, training, and 24/7 support. For organizations whose primary need is continuous environmental monitoring — not process validation — this eliminates the cost of capabilities they do not require.
Side-by-Side Comparison
| Factor | Ellab | ATEK | Advantage |
|---|---|---|---|
| Thermal validation expertise | ValSuite Pro gold standard | Not offered | Ellab |
| Validation data loggers | TrackSense Pro, E-Val Pro | Not offered | Ellab |
| Novo Holdings pharma ecosystem | Direct ownership | Independent | Ellab |
| DANAK/DAkkS calibration heritage | Accredited labs (Denmark/Germany) | A2LA (Canada) | Comparable |
| Continuous monitoring platform maturity | SKY (secondary product) | Core platform | ATEK |
| Cloud-native monitoring architecture | Available | Purpose-built | ATEK |
| 24/7 support with response guarantee | Business hours (Europe) | 5-minute, 24/7 | ATEK |
| Canadian data hosting (PIPEDA) | Not available | Canadian-hosted | ATEK |
| All-inclusive monitoring pricing | Component billing | Per-point, bundled | ATEK |
Who Benefits Most from Switching
- Organizations using Ellab SKY for monitoring but not ValSuite for validation — facilities whose primary need is continuous environmental monitoring, not thermal process validation, and who are paying enterprise validation-company pricing for a monitoring-only deployment
- Stability chamber monitoring programs that need 24/7 real-time alerting, cloud-based access, and integrated compliance reporting rather than a validation-centric platform adapted for continuous monitoring
- Canadian pharmaceutical facilities requiring local calibration, Canadian data hosting with PIPEDA compliance, and bilingual support — logistics that are difficult to achieve through Ellab’s European infrastructure and Houston sales office
Making the Transition
Moving from Ellab SKY monitoring to ATEK follows a structured approach that respects existing compliance documentation:
- Deployment mapping — We document your current SKY sensor locations, alarm thresholds, reporting configurations, and integration points with any LIMS, BMS, or quality management systems. If ValSuite Pro is in use for validation, we identify which monitoring functions are handled by SKY versus ValSuite to scope the transition accurately
- Parallel monitoring — ATEK wireless sensors install alongside existing Ellab SKY sensors. Both systems capture environmental data simultaneously, allowing your QA team to compare readings and validate ATEK performance against established baselines without interrupting ongoing monitoring
- Compliance validation — Complete IQ/OQ/PQ documentation is included. Our team produces qualification protocols aligned with your existing validation framework, ensuring continuity of compliance documentation through the platform change
- Cutover and training — Phased transition by monitoring zone or facility, with 24/7 support during the first 30 days. Because ValSuite Pro validation workflows are independent of environmental monitoring, organizations that use both can transition monitoring to ATEK while retaining ValSuite for process validation
When Ellab May Be the Right Fit
Ellab is the clear choice for organizations whose primary need is thermal process validation. If your core requirement is qualifying autoclaves, freeze-dryers, sterilizers, or depyrogenation tunnels, ValSuite Pro and TrackSense Pro represent the industry benchmark. Organizations deeply embedded in Ellab’s validation ecosystem — with established ValSuite protocols, trained validation engineers, and active DANAK/DAkkS calibration relationships — may prefer to consolidate monitoring under the same vendor. Novo Holdings ownership provides institutional credibility valued by conservative pharmaceutical compliance committees evaluating vendor stability.
When ATEK Is the Better Choice
Choose ATEK when you need:
- A purpose-built continuous monitoring platform rather than a validation company’s secondary monitoring product
- Cloud-native architecture with real-time 30-second data intervals for stability chambers, cleanrooms, and cold storage
- 24/7 live support with guaranteed 5-minute response from a North American team, not European business hours
- A2LA-accredited calibration from a Canadian lab without cross-border shipping to DANAK/DAkkS facilities
- All-inclusive per-point pricing instead of separate line items for SKY hardware, ValSuite licensing, calibration, and consulting
Start with a free assessment to evaluate how ATEK’s monitoring-first platform compares to your current Ellab deployment.
Frequently Asked Questions
Can ATEK replace Ellab’s ValSuite Pro for thermal validation?
No — and it is not designed to. ATEK is a continuous environmental monitoring platform, not a thermal validation system. ValSuite Pro serves a different function: qualifying autoclaves, freeze-dryers, and sterilizers through time-limited validation studies. Many organizations use Ellab for process validation and a separate platform for 24/7 environmental monitoring. ATEK replaces the monitoring function (Ellab SKY), not the validation function (ValSuite Pro).
How does ATEK’s compliance compare to Ellab’s for environmental monitoring?
Both platforms support FDA 21 CFR Part 11 and EU GMP Annex 11 compliance for environmental monitoring data. ATEK provides electronic signatures, complete audit trails, and ALCOA+ data integrity principles natively in a cloud-native platform. Ellab’s compliance depth is strongest in validation documentation through ValSuite Pro. For continuous monitoring specifically, ATEK’s purpose-built platform offers deeper alerting, reporting, and data integrity features than Ellab’s SKY system.
Is Ellab’s SKY monitoring system comparable to ATEK’s platform?
Ellab SKY provides environmental monitoring, but it was developed as an extension of a validation-focused company. ATEK’s platform was designed exclusively for continuous monitoring with features like 30-second real-time data intervals, cloud-native architecture with automatic updates, integrated compliance documentation, and 24/7 alerting with guaranteed response times. The difference reflects each company’s primary focus: Ellab leads in validation, ATEK leads in monitoring.
What about calibration — does ATEK match Ellab’s DANAK/DAkkS accreditation?
Both hold internationally recognized calibration accreditation through different bodies. Ellab maintains DANAK (Denmark) and DAkkS (Germany) accreditation, which carry full international mutual recognition. ATEK operates an A2LA-accredited lab in Canada, also internationally recognized. For Canadian and North American facilities, ATEK’s local lab eliminates cross-border shipping delays. For European facilities, Ellab’s calibration infrastructure is geographically advantageous.
How long does migration from Ellab SKY to ATEK take?
Typical migrations complete within 2-4 weeks per facility, including parallel operation. The timeline depends on the number of monitoring points, integration requirements, and your QA team’s validation review cycle. Because ATEK sensors are wireless and pre-calibrated, physical installation is measured in hours. The parallel monitoring phase — running both systems simultaneously — usually runs 1-2 weeks to establish baseline confidence. Schedule a consultation for a timeline specific to your deployment.
Can we keep Ellab ValSuite for validation and use ATEK for monitoring?
Yes — this is a common and logical approach. Ellab’s strength is thermal process validation (autoclaves, freeze-dryers, sterilizers), while ATEK specializes in continuous environmental monitoring (cleanrooms, stability chambers, cold storage). The two platforms serve complementary functions. Organizations can use ValSuite Pro and TrackSense Pro for qualification studies while relying on ATEK for 24/7 real-time environmental monitoring and alerting.