GxP-compliant pipelines
Data flows built under change control, with IQ, OQ and PQ evidence generated as the pipeline is built rather than assembled retrospectively.
Industries
Life Sciences
In a validated environment, a change to a system is a change to a controlled process. We build data platforms and integrations that can carry that weight, and the documentation that keeps them compliant.
Validated data platforms
Validation is cheaper when it is designed in. We produce the qualification evidence alongside the build instead of reconstructing it in the weeks before an audit.
Lab system integration
LIMS, ELN and instrument data brought into one place, with instrument output captured in its raw form so results stay reproducible.
21 CFR Part 11 controls
Electronic records and signatures, audit trails and access control implemented to the letter — including the retention requirements that are usually skipped.
Clinical data management
EDC integration, SDTM mapping and the transformations between them, versioned so a submission can be reproduced years after the fact.
Research and manufacturing analytics
Once the data is trustworthy, the questions get more interesting. These are the engagements that tend to follow a platform build.
Research data lakes
Assay, genomic and screening data in one governed store, with the metadata that keeps it findable two years after the scientist who produced it has moved on.
Manufacturing and batch analytics
Batch records and process data analyzed for deviation patterns, with every result traceable back to the batch it came from.
Submission readiness
Datasets, define files and traceability prepared to the standard a regulatory submission actually requires.
How we help
Our six practices, applied to life sciences
AI strategy & implementation
AI applied where validation and reproducibility can be demonstrated.
Cybersecurity
Protection for research IP and clinical data across partner boundaries.
Data modernization
Research, clinical and manufacturing data in one governed store.
Cloud & cost optimization
Qualified cloud environments with the documentation to match.
Software development
Validated applications built and changed under change control.
Strategic IT planning
Roadmaps aligned to study timelines and submission dates.
Validated by design, not by remediation.
Retrofitting evidence onto a finished system is the most expensive way to reach compliance, and the least convincing one.
Talk to an expert today
A 20-minute call with a senior consultant. You’ll leave with a clear next step, whether or not we work together.