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High-fidelity pharma operations

With immutable data integrity.

Connect your bioreactors, freeze-dryers, and eBR/batch record systems into one high-compliance data layer. Monitor critical process parameters in real-time to safeguard quality, accelerate release cycles, and reduce audit risk.

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high-fidelity pharma operations deployed at and trusted by

If it isn't documented correctly, it didn't happen

The reality in pharma is often still a "Paper Gap": data manually transcribed from screens into logs. This creates bottlenecks in batch release and significant risks during regulatory audits. Helixer closes this gap by building an unbroken digital chain. We don't focus on "nice-to-have" features; we focus on removing the single greatest threat to your operation: human error in critical data.

Stage 01

Automated Capture

Eliminate the dependency on manual logs. Helixer captures every pulse from your bioreactors, freeze-dryers, and centrifuges. Raw sensor data is converted into a standardized format instantly, without human intervention.

Stage 02

Real-time Validation

Data only has value with the right context. Every value is immediately verified against ALCOA+ standards. Is it legible? Is it contemporaneous? Is it original? Helixer validates this in milliseconds, not days.

Stage 03

Deviation Prevention

While the batch is running, we monitor the 'Validated Window'. If a Critical Process Parameter (CPP), such as pH or temperature, threatens to drift, the operator receives a predictive alert, so you can intervene before a batch is lost.

Stage 04

Instant Batch Release

The final destination is a cryptographically sealed dossier. Because the data has been validated throughout the process, batch release lead times are drastically reduced. You are audit-ready, every second of the day.

€5M–€30M Potential Cost

of a single discarded batch or a significant regulatory non-compliance finding.

-40% Average reduction

in batch release cycles by moving from manual data collection to an automated, immutable audit trail.

“Helixer has become a trusted part of our core operations. The automation of sintering validation significantly improved data quality and process efficiency, while reducing manual effort and risk”

Hans Van Donge CEO CAM Bioceramics Hans Van Donge, CEO CAM Bioceramics

See how CAM Bioceramics replaced paper logs with a real-time, audit-ready data layer for batch release.

3-day proof of value sprint

In just three days, our team joins you on-site to connect your first machines, visualize live data, and reveal tangible opportunities for improvement.

No long contracts, no empty promises, just proof that Helixer OS delivers real value where it matters most: on your shop floor.