| Measure | Result |
|---|---|
| Operator paperwork | −80% |
| Traveler review time for engineers | −90% |
| Process innovation time | −15% |
1The challenge.
Paradromics is developing a brain–computer interface: technology that decodes neural activity and translates it into action. For people with ALS or paralysis, it offers a path back to communication.
Documentation could not keep pace with development. Operators spent 30 to 60 minutes per process on manual paperwork. Senior engineers spent a combined 3 to 4 hours every day reviewing paper travelers, time taken from the iteration that drives the company forward.
Process data was scattered across paper, digital forms and legacy systems. When rework happened and the team needed the root cause, the investigation meant searching across formats. Traceability, which regulators will scrutinise closely, was assembled by hand when needed rather than maintained as the work happened.
Operational decisions compound: clean data now supports a defensible submission later, while messy data means reconstructing history under audit pressure.
2What changed.
Paradromics implemented Seal as one operational platform for manufacturing execution, quality management and electronic records, with one source of truth for process data.
Operators moved from paper travelers to guided digital workflows. The 30 to 60 minutes of paperwork per process became execution in the system, with the record filling in as the work happened. Engineers stopped reviewing handwritten travelers and now review the exceptions the system surfaces.
Consolidating the data made the larger difference. Non-conformance reports, calibration records, process history and training status sit in one platform with a consistent structure, so analysing a rework or tracing a component starts with a query rather than a search.
Starting from Seal’s existing platform and its validation evidence meant Paradromics did not have to build quality infrastructure from scratch, and could keep engineering effort on the BCI itself.
3The outcome.
Operator paperwork fell by 80%. Operators recovered most of the 30 to 60 minutes per process that had gone to manual documentation.
Traveler review time for engineers fell by 90%. Most of the combined 3 to 4 hours a day went back to process improvement and development work that had been crowded out.
Process innovation time fell by 15%. New workflows reuse existing structured data, so engineers are not recreating protocols from scratch, and the configuration for one process becomes the starting point for the next.
With operational data now centralised and structured, Paradromics has a dataset that paper records could not provide, and is beginning to use it for process flow optimisation and quality trending.
4From the team.
“Since implementing Seal, we’ve reduced operator paperwork time by over 80%, allowing our team to focus on core process improvement. I am hugely excited about the next stage of utilizing the system to query a single, unified set of data to find further opportunities for process development.”
“The Seal team has been collaborative through our launch...the customization opportunities are exciting, and as a pre-clinical company we are glad to be laying the foundation for future growth and compliance needs with confidence that the platform will continue to evolve alongside us.”
Published .
Start with one process.
Bring a procedure, a batch record or an investigation. We’ll scope the first piece of work together. More customer stories.
Book a demo