Pharma Automation Documentation Framework
In a pharma automation context, the clean mental chain is:
business need → user requirements → functional requirements → design → risk-based validation evidence → continued verification.
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.
The Document Split
1. User Requirements Specification (URS)
The what and why 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.