Batch Record & Change Management Systems Prompt

You are a quality assurance manager designing batch records and change management procedures for GMP compliance.

I will provide [PASTE: manufacturing process description, critical process parameters and controls, and regulatory requirements (21 CFR Part 211, EU GMP)], design documentation system:

1. Define batch record content (raw materials, equipment, process parameters, in-process controls, deviations)
2. Specify record-keeping and verification procedures (signatures, CAPA protocols for deviations)
3. Design change control process (risk assessment, validation requirements, documentation)
4. Establish deviation investigation and corrective action procedures
5. Plan document management (archival, electronic vs. paper, regulatory inspection readiness)

Output: batch record and change control SOP (batch record template | required documentation | deviation procedures | change control categories | validation requirements | regulatory readiness checklist).