Compliance
Compliance for omics data analysis in clinical trials, diagnostics and clinical laboratories. A quality and run report by construction on the platform, with validation documentation scoped to your regulatory perimeter.
Keywords

Compliance services, GCP, ICH E6 R3, GAMP 5, Computer Software Assurance, 21 CFR Part 11, EU Annex 11, IEC 62304, ISO 14971, ISO 13485, IVDR, CLIA, CAP, ISO 15189, Bioinformatics validation, Analytical validation, Evidence by construction, Data Intuitive

All services Compliance

Evidence by construction.
Validation stays yours.

Every run is versioned, containerised and logged, so most of the evidence an auditor asks for already exists. The validation decision, and the responsibility for it, sit with you as the sponsor, the manufacturer or the laboratory.

What applies to you depends on what the result is used for, not on the assay.

Where the line sits

Most of the evidence is already there

The platform produces the record as it runs.
Anything your regime asks for on top of that, we build with you.

The platform gives you

  • A versioned, containerised workflow, pinned to a digest
  • A quality and run report per run: inputs, parameters, versions, by whom and when
  • A component inventory and the automated test evidence behind it
  • Qualification records for your own installation
  • Access control and an audit trail, on your infrastructure

We build what your regime needs

  • A bioinformatics analysis plan to sit with the protocol
  • Version lock and change control around a database lock
  • Documentation mapped to your regime, from GAMP 5 and CSA to Part 11 and Annex 11
  • Computational performance evidence for the validation your laboratory runs
  • Work alongside your own compliance partner where a full validation exercise is needed

These are the regimes we build documentation for, and all of them govern software and data rather than bench work: GAMP 5 second edition · FDA Computer Software Assurance · 21 CFR Part 11 · EU Annex 11 · IEC 62304 · ICH E6(R3) GCP.
Device and laboratory regimes stay with you. Where ISO 14971, ISO 13485, IVDR, CLIA, CAP or ISO 15189 apply, we supply the computational evidence they ask for and you hold the obligation. We run no laboratory.

Perimeter

What changes, and when

The same analysis carries different obligations depending on the decision it supports.

Exploratory researchNo regulatory regime
Nothing changes. This is the platform default.
Exploratory trial endpointsICH E6(R3) GCP
The analysis is written into the protocol or an analysis plan. Every run records which samples it read, who started it and when, and that record can be handed to a reviewer.
Primary, secondary or stratification endpointsGAMP 5 · CSA · Part 11 · Annex 11
The workflow version is locked before database lock. Blinding holds in the analysis environment. Changes go through change control.
IVD or companion diagnosticIVDR · IEC 62304 · ISO 14971 · ISO 13485
You are the manufacturer. Design control, traceability and release are yours. We supply the platform you build on.
Laboratory-developed testCLIA and CAP · ISO 15189
Your laboratory owns the validation. We supply the version-locked workflow and the evidence it asks for.

One workflow can move up this list over its life. Building the quality and run report from the first experiment is what makes that move straightforward.

The first step

Bring us the question you keep re-answering.

In 45 minutes we listen to what you need, mark what already runs for your instrument and kit and think through how we would solve the rest with you.

Book a meeting