GxP AI Workflow Cheat Sheets
Pilot Program: AI-Augmented Quality Engineering
1. Process Validation Assistant
Objective: To instantly locate and cross-reference key process validation documents and proactively identify potential compliance gaps in validation plans and reports.
The Problem: A Quality Engineer needs to review a new Process Qualification (PQ) protocol. They spend significant time manually searching through the document management system (DMS) to find the related FMEAs, TMVs, and characterization data. It's easy to miss a critical link, like a validation that mentions process capability but fails to include the required normality assessment.
The AI-Powered Solution: Copilot acts as an intelligent assistant, scanning all relevant source documents simultaneously to find information and flag potential gaps based on pre-defined quality rules.
Step-by-Step Guide
Step 1: Gather Your Source Documents
• Collect the primary document for review (e.g., PQ-Protocol-123.pdf).
• Identify related source files (e.g., FMEA-XYZ.pdf, TMV-456.xlsx, SOP-QMS-015_Validation.pdf).
Step 2: Use the Approved GxP Prompt
• Open Copilot and attach all source documents.
• Use the following structured prompt:
"Act as a senior quality engineer. Your goal is to review the attached Process Qualification protocol (PQ-Protocol-123.pdf) for completeness against our validation SOP (SOP-QMS-015_Validation.pdf).
1 Cross-reference the protocol with the attached FMEA and TMV to ensure all high-risk failure modes and measurement systems are addressed.
2 Scan the protocol for any mention of 'process capability' or 'Cpk/Ppk'. If found, verify that 'normality assessment' or 'data distribution' is also discussed as required by the SOP.
3 Provide a bulleted list of your findings, citing the relevant document and page number for each point."
Step 3: Human-in-the-Loop (HITL) Verification
• You are the final authority. The AI's output is a draft for verification.
• Review each bullet point generated by the AI.
• Click on the citations provided by Copilot to navigate directly to the source document and confirm the accuracy of each finding.
• Incorporate the verified findings into your official document review record.
Example AI Output
• Finding 1: The protocol addresses the high-risk failure mode FMEA-XYZ-003 (Seal Integrity) in Section 4.2. (Source: PQ-Protocol-123.pdf, pg. 5)
• Finding 2: The protocol references TMV-456 for the tensile tester measurement system. (Source: PQ-Protocol-123.pdf, pg. 6)
• GAP IDENTIFIED: Section 5.1 discusses process capability and Cpk targets, but there is no mention of performing a normality assessment on the data, which is a required step per SOP-QMS-015_Validation.pdf, Section 8.3.
Key Benefits:
• Time Saved: Reduces manual document search and cross-referencing time by an estimated 70-80%.
• Risk Reduction: Proactively identifies compliance gaps that could lead to audit findings or batch rejections.