Resources

The Annex 11 revision explained

hello@entelion.com (Entelion) — Thu, 06 Aug 2026 09:00:00 GMT

This article outlines the Annex 11 revision and what it means for validation teams working with computerized and AI-driven systems.

hello@entelion.com (Entelion) — Wed, 05 Aug 2026 09:00:00 GMT

Computer Software Assurance reframes how teams prioritize testing. This post summarizes the shift from traditional CSV to a risk-based CSA approach.

hello@entelion.com (Entelion) — Tue, 04 Aug 2026 09:00:00 GMT

GAMP 5 remains the shared reference for life-science software validation. Here's how teams apply its Second Edition alongside modern AI workflows.

hello@entelion.com (Entelion) — Mon, 03 Aug 2026 09:00:00 GMT

AI systems introduce new validation challenges: model drift, data lineage, and explainability. Here's how we're framing the problem.

hello@entelion.com (Entelion) — Sun, 02 Aug 2026 09:00:00 GMT

Signed protocols age the moment the system changes. Validation only holds up if it's treated as a living control, not a one-off event.

hello@entelion.com (Entelion) — Sat, 01 Aug 2026 09:00:00 GMT

Teams often ask whether continuous validation replaces re-validation. This guide compares triggers, evidence packs, and decision criteria.