https://hjohansen.dk/en/tags/ich-q9/Recent content in Ich-Q9 on HJohansen.dkHugoen-USSun, 24 May 2026 10:00:00 +0200https://hjohansen.dk/en/knowledge/pharma/framework/Sun, 24 May 2026 10:00:00 +0200https://hjohansen.dk/en/knowledge/pharma/framework/<p>In a pharma automation context, the clean mental chain is:</p> <p><strong>business need → user requirements → functional requirements → design → risk-based validation evidence → continued verification.</strong></p> <p>FDA describes process validation as a lifecycle (three stages, not a one-time event), and ICH Q9 says the level of effort, formality, and documentation should match the level of risk.</p> <h2 id="the-document-split">The Document Split</h2> <h3 id="1-user-requirements-specification-urs">1. User Requirements Specification (URS)</h3> <p>The <em>what</em> and <em>why</em> from the user/business side. Describes process intent, operator needs, data capture, compliance needs, quality outcomes. ISA-88 gives a shared batch-control language for structuring this.</p>