Industries
Validated systems for regulated science
Research data platforms, quality systems and validated software for biotech, pharmaceutical and diagnostics companies, built to pass inspection and still be pleasant to use.
Talk to our life sciences team
What is changing
In life sciences every system that touches a product or a trial must be validated, and every change documented. That has long made regulated software slow to improve. The companies moving fastest now treat validation as engineering: automated, versioned and part of every release.
Research teams produce more data than ever from instruments, sequencing and imaging, yet much of it is hard to find once a project ends.
Trials are increasingly run outside the clinic, with patients reporting from home and sites spread across many countries.
Three shifts in regulated science
Validation as code
Test evidence produced automatically by every release, so a validated system can change monthly instead of once a year.
Research data that outlives the project
Findable, well-described data the next team can reuse, instead of folders on a drive that nobody remembers.
Trials beyond the clinic
Remote visits, wearables and patient diaries bring new sources of data into regulated pipelines, each of which has to be trusted.
By the numbers
Life sciences, measured
- 70%
- Less effort per release on validation documentation after moving to automated test evidence, across four clients.
- 12
- Regulatory inspections our clients' validated systems have passed since 2021 with no critical findings.
- 3x
- More datasets reused by a second team within a year, once research data was catalogued and described.
KIASA delivery records for biotech, pharmaceutical and diagnostics clients, 2021 to 2026.
What we do
How we help life sciences companies
Our teams include quality engineers who write validation plans as readily as code, and speak to quality assurance in its own terms.
Computer system validation
Risk-based validation built into the delivery pipeline, with evidence generated by every release and kept ready for inspection.
Quality engineeringResearch data platforms
Instrument and experiment data captured, described and catalogued so that it can be found and reused years later.
Artificial intelligence and dataLaboratory and quality systems
Lab information, document control and quality management systems configured to your procedures and integrated with each other.
Enterprise platformsClinical trial systems
Patient apps, site portals and data capture for decentralized trials, built to the standards trial data requires.
Digital product engineeringData integrity and security
Audit trails, access controls and electronic signatures designed in, and tested against the way data could be altered.
CybersecurityQualified cloud foundations
Cloud platforms qualified once and kept in a validated state automatically, so each new system starts on solid ground.
Cloud and platform engineering
Validation
Release monthly, stay validated
Most validated systems change once or twice a year, because each change brings weeks of documents. Users wait for fixes, and the backlog grows into a project of its own.
We turn the validation plan into automated tests that trace each requirement to its evidence. Every release produces its own validation package, reviewed by quality assurance in days. The system stays validated, and it gets better every month.
See quality engineering
Research data
Research data the next team can use
A dataset is only valuable if someone can find it, understand it and trust it. In many research organizations that knowledge leaves with the scientist who produced it.
We capture data at the instrument, describe it as it is created and keep it in a catalog scientists actually search. Lineage shows where every result came from, which is what a regulator will ask, and what the next team needs to know.
See artificial intelligence and dataOur work in action
What we have built with life sciences companies
Aurelin Biologics
A biologics maker moves its quality system to the cloud and keeps it validated
A qualified cloud foundation, an automated validation package and an inspection passed six months later.
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Quillon Diagnostics
A diagnostics company releases its lab software every month under full validation
From two releases a year to twelve, with quality assurance reviewing evidence rather than writing it.
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Sorrel Clinical Research
A research organization collects patient diaries from eleven countries
A patient app and site portal for a decentralized trial, translated, validated and live in five months.
Explore
What we think
Reading for life sciences leaders
Perspective
Why the second year of a cloud migration matters more than the first
Regulated workloads in the cloud bring new habits as well as new costs. What changes in the second year.
Research report
AI in the back office: where the first real savings are showing up
Document review and data entry are where AI is earning its place first. Lessons for regulated teams.
Research report
Security debt: the quiet risk on the balance sheet
Data integrity depends on systems that are patched and controlled. How to measure what has been left undone.
Perspective
Green software is mostly just good software
Research computing is energy hungry. Simple engineering choices that cut its carbon cost.
Our leaders
Life sciences leads
Engineers and scientists who have sat on both sides of an inspection.
Dr. Helena Varga
Industry Lead, Life Sciences
Worked in pharmaceutical research and quality before moving into technology. Leads our work with biotech and diagnostics companies.
Vikram Desai
Validation Engineering Lead
Turns validation plans into automated tests, and has taken systems from annual to monthly releases.
Chiara Bellini
Research Data Lead
Designs research data platforms that scientists use, with lineage a regulator can follow.
Build it once, validate it every time
Tell us which system you would like to change more often. A partner from our life sciences team will reply within two working days.