When to use a Directive
Use a Directive when you want Sofie to consistently follow a rule. Good Directive examples:For deviation work, separate facts, assumptions, missing evidence, and recommended next checks.Do not infer root cause unless supplied sources support it.When summarizing meetings, include decisions, action items, owners, due dates, risks, and unresolved questions.For validation documents, preserve requirement IDs and acceptance criteria.When drafting QA-facing language, avoid unsupported causal claims.
- Conflict with your team’s required process.
- Tell Sofie to skip human review.
- Bake in temporary project facts.
- Are so broad that they apply poorly to most tasks.
Open Directives
1
Open Manage Memory
Open Manage Memory from the user menu.
2
Select Directives
Click the Directives tab.
3
Review active rules
Check which Directives are active and whether any are stale.
Directive fields
When you create or edit a Directive, Sofie can show:
Good names:
Deviation evidence standardQA-facing languageMeeting summary formatValidation source handlingCAPA traceability
Create a Directive
1
Open Directives
Go to Manage Memory and select Directives.
2
Click Create
Click Create.
3
Name the Directive
Enter a clear Name.
4
Write the rule
Enter the standing instruction in Rule.
5
Add optional reasoning
Use Reasoning to explain why the rule matters.
6
Save
Click Save.
Turn a Directive on or off
Directives can be active or inactive. Turn a Directive off when:- It applies only to a past project.
- It conflicts with a current task.
- You want to test a different response style.
- It is too broad and needs revision.
Edit or delete a Directive
1
Find the Directive
Search or scan the Directives table.
2
Open the row menu
Use the row action menu.
3
Choose Edit or Delete
Edit the Name, Rule, or Reasoning, or delete the Directive if Sofie should no longer follow it.
Directive examples by workflow
Deviation investigation
Deviation investigation
CAPA development
CAPA development
Validation review
Validation review
Regulatory research
Regulatory research