Automate GxP processes in pharmaceutical manufacturing

Our GxP-ready pharma 4.0 software suite reduces QA-related delays and makes regulatory compliance easier to manage.

pharma 4.0

No industry touches people’s lives like pharma. And that comes with a unique set of challenges.

The burden of monitoring and documenting regulatory compliance makes efficiency crumble, but failure to comply comes with devastating consequences for business and for patient safety.

With software solutions that automate key processes and give production and QA teams shared, data-based evidence for making decisions with speed and confidence, we’re here to make compliance easier to manage.

Software solutions that automate GxP processes and deliver data-based evidence

Production and QA teams deserve better tools: 30% of staff time is spent on documentation-related activities and the biggest delay in batch releases is related to the QA function. 

For process engineers and QA

Product and process validation without endless trial and error

The paradox of process validation: Tons of documentation but no structured evidence on which to base decisions.

The result: Downtime and delays in relation to NPI, material changes, system updates and requalification.

Our software enables early-stage product testing and deliver granular, real-time process insights while automatically logging parameter changes, also on 3rd party systems/components.

Read more about inspections Read more about data insigths
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For production and QA teams

Say goodbye to the paper stacks with centralized audit trails

Find the data you need in a matter of minutes.

TRACKS Audit Hub automatically logs audit trails from components, machines, production lines or entire facilities and centralizes them in one searchable database.

See how audit trails can become useful
Screen showing the UI of TRACKS Audit Hub with parameters neatly sorted and color-coded to highlight changes between FAT and SAT
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For production teams

On to the next batch - faster

The mandatory processes before a batch are manual, time-consuming and error-prone, often triggering deviations that lead to further delays in batch start/release.

Our software provides a unified view of the previous batch run and parameter changes. It also automates processes around material reconciliation, line clearance and late-stage customization.

Read more about automated line clearance Read more about inline label printing
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Join these ambitious pharma companies in automating GxP processes

Want to automate GxP processes?

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