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Pharma Automation Documentation Framework

Sun, 24 May 2026 10:00:00 +0200

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.

The Traceability Chain

Sun, 24 May 2026 09:30:00 +0200

A useful mental model for how engineering documentation fits together:

Business Need
 ↓
Requirements (what)
 ↓
Acceptance Criteria (how to verify what)
 ↓
Design (how to build it)
 ↓
Implementation
 ↓
Tests (based on acceptance criteria)

Key Principles

1. Traceability is Key

Every requirement should link to:

a design element
one or more acceptance criteria
one or more tests

2. Avoid Mixing Levels

Common mistakes:

Design Documents

Sun, 24 May 2026 09:00:00 +0200

Design documents describe how requirements will be implemented. They bridge requirements → implementation → verification.

What They Are For

Translate requirements into system structure
Align developers and engineers before implementation
Define interfaces, data flows, and responsibilities
Reduce ambiguity in complex systems
Provide traceability back to requirements

Typical Structure

Overview — purpose, scope, assumptions, constraints
Requirements reference — links to relevant requirements (traceability matrix optional)
High-level architecture — components, responsibilities, data flow
Detailed design — data structures, state machines, algorithms, interface definitions
Edge cases and failure handling — recovery strategies, validation rules
Non-functional considerations — performance, security, maintainability, scalability
Open questions / decisions — design trade-offs, alternatives considered

What a Design Document is NOT

Not a requirements document
Not a step-by-step implementation script
Not code (though diagrams and pseudocode are fine)

Se også: Requirements Engineering, Pharma Automation Framework

Acceptance Criteria

Sun, 24 May 2026 08:30:00 +0200

Acceptance criteria define how you prove a requirement is satisfied. They are concrete, verifiable, written in behavior terms, and often expressed as scenarios or rules.

Common Formats

Rule-based

Given X, system shall do Y.

Scenario-based (Given / When / Then)

Given a valid batch recipe, When the user starts execution, Then the system shall validate parameters before proceeding.

Key Properties

Binary outcome — pass or fail, no ambiguity
Focus on observable behavior — not implementation details
Directly usable for testing — a tester can derive test cases

Relationship to Requirements

Requirements	Acceptance Criteria
What is needed	How we know it works
The goal	The proof
Can be abstract	Must be concrete

Think of acceptance criteria as the test contract for a requirement. Every requirement should link to one or more criteria.

Requirements Engineering

Sun, 24 May 2026 08:00:00 +0200

Requirements describe what the system must achieve, not how. They sit at different levels of abstraction.

Levels of Requirements

1. Business Requirements

The highest-level intent. Expresses why something is needed. Usually stable over time.

“The system shall reduce manual batch configuration errors.”

2. User / Functional Requirements

Describes system behavior from a user or process point of view. Focuses on what the system does.

“The system shall validate all recipe parameters before execution.”

First Post

Sun, 17 May 2026 13:10:46 +0200

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