Write Standard Operating Procedure

Create a GxP-compliant Standard Operating Procedure that provides clear, auditable instructions for regulated activities.

When to Use

• A new validated system requires operational procedures
• Existing procedures need formalisation into SOP format
• An audit finding cites missing or inadequate procedures
• A change control triggers SOP updates
• Periodic review identifies outdated procedural content

Inputs

• Required: Process or system the SOP covers
• Required: Regulatory context (GMP, GLP, GCP, 21 CFR Part 11, EU Annex 11)
• Required: Target audience (roles that will follow this SOP)
• Optional: Existing informal procedures, work instructions, or training materials
• Optional: Related SOPs that interface with this procedure