Existing-pipeline audit
Structured review of processing steps, parameters, software dependencies, versions, controls, results and available traceability evidence.
Bioinformatics audit
Bioinformatics audit
Review of an existing pipeline, qualification of a new version, non-regression testing strategy, traceability and bioinformatics documentation for quality or accreditation processes.
Services
Review and qualification adapted to the laboratory context
Pipeline qualification
Scope definition, reference test sets, edge cases, acceptance criteria, performance metrics and expected evidence.
Change & non-regression testing
Impact analysis, version comparison, non-regression datasets and documentation of changes.
Documentation & accreditation
Organisation of bioinformatics evidence: pipeline description, versions, test sets, acceptance criteria, qualification results and traceability.
Outputs
Audit and qualification outputs
Audit reportFindings, risks, improvement points and action priorities.
Qualification planScope, test cases, acceptance criteria and expected evidence.
Non-regression testingReference datasets, expected outputs and post-change comparison.
Traceability matrixLinks across versions, requirements, tests, results and documentation.
Technical documentationMethods, parameters, versions, procedures and review material.
Action planPrioritised recommendations aligned with the agreed scope.
Quality context
Qualification aligned with intended use
For an NGS method, the bioinformatics chain is one component to qualify and document within the overall verification or validation strategy. Scope should reflect intended use, expected performance and version changes.
Your need
Discuss a bioinformatics audit
Describe the workflow, change, qualification need or documentation context to review.