Using AI in Drug Development Without Creating Compliance Risk

flowchart TD
 A[Source documents and approved data] --> B[AI assists with draft, summary, search, or check]
 B --> C[Human reviews against source]
 C --> D{Accurate and appropriate?}
 D -->|Yes| E[Use in working draft or next step]
 D -->|No| F[Revise, reject, or escalate]
 E --> G[Document tool, review, and version]
 F --> G

flowchart TD
 A[Define the task] --> B{Touches GxP record or decision?}
 B -->|No| C{Sensitive data involved?}
 B -->|Yes| D{Human can verify against source?}
 C -->|No| E[Lower-risk pilot candidate]
 C -->|Yes| F[Use approved tool and data controls]
 D -->|Yes| G[Add review, logging, and sign-off]
 D -->|No| H[Do not deploy this use case]
 F --> G

flowchart TD
 A[Select bounded task] --> B[Use approved tool and data]
 B --> C[Generate draft or triage suggestion]
 C --> D[Check against source material]
 D --> E{Issues found?}
 E -->|Yes| F[Revise or discard output]
 E -->|No| G[Human approves next use]
 F --> D
 G --> H[Log decision and version]

flowchart TD
 A[Time pressure hits] --> B[User picks fastest AI tool]
 B --> C[Sensitive data pasted into prompt]
 C --> D[Model returns fluent draft]
 D --> E[Reviewer skim-approves]
 E --> F[Output enters regulated workflow]
 F --> G[Error or exposure discovered later]

flowchart TD
 A[Need help with a task] --> B{Approved tool available?}
 B -- No --> C[Stop and request review]
 B -- Yes --> D{Input data classified?}
 D -- No --> E[Classify data first]
 D -- Yes --> F{Sensitive or GxP content?}
 F -- Yes --> G[Use controlled workflow and sign-off]
 F -- No --> H[Use tool with human review and logging]
 G --> I[Document output and decisions]
 H --> I[Document output and decisions]