Regulatory Considerations

This page is informational only and does not constitute legal, regulatory, or quality advice. Consult your regulatory affairs team before using any software in a GMP context.

Is perfusio GxP-validated?

No. perfusio is a research library released under the Apache-2.0 licence. It has not been validated under 21 CFR Part 11, Annex 11, or any other GMP framework.

Using perfusio in a Research / Development Context

perfusio is appropriate for:

  • Pre-GMP process development and optimisation.

  • Generating hypotheses and experimental designs.

  • Academic publication and benchmarking.

Path to GMP Deployment

If you wish to use the methodology in a GMP-regulated context, you will typically need to:

  1. Source-code qualification — Lock to a specific release tag; document all changes.

  2. Installation Qualification (IQ) — Verify that the library installs correctly on your validated compute environment.

  3. Operational Qualification (OQ) — Run the provided test suite; confirm 92% line / 85% branch coverage pass.

  4. Performance Qualification (PQ) — Execute the paper-figure reproduction scripts and compare output to archived reference images.

  5. 21 CFR Part 11 / Annex 11 controls — Implement audit trail, access control, and electronic signature wrappers around AuditLogger and SQLStore.

Audit Trail

perfusio.twin.audit.AuditLogger logs all sampling events and setpoint changes with ISO 8601 timestamps, operator ID, and a SHA-256 hash of the state dict. This provides a technical foundation for audit trails but does not replace a validated audit trail system.

Data Integrity

All OPC UA reads are validated against configured engineering limits before being stored. Rejected reads are logged with reason codes.

Contact

For GMP consulting around perfusio, contact the corresponding author of Gadiyar et al. (2026) or open an issue on GitHub.