Who Is This For?
System Administrators – configuring data structures and governance
QA Administrators – enforcing compliant controls (change control, access, due dates)
Process Owners – defining how records of a process should behave
How to Do It
Step 1: Create a New Entity Type
Create the foundational category used to classify and manage records.
Go to Settings in the sidebar.
Select Types.
Click New Entity Type.
Enter a name for the new entity type.
Click Save.
💡 Tip: Use a clear, singular name (e.g., “Training Record”, “CAPA”, “SOP”).
Step 2: Configure Entity Type Properties
Set behavior for numbering, creation rights, due dates, access controls, and change control.
❗ Compliance reminder: Tighten controls (Classified Access and Change Request) for records that impact product quality, patient safety, or regulatory compliance.
Property | Options | What it Controls |
ID Numbering Strategy* | Global / Local / Manual | Global – shares a single sequence across the organization. Local – sequence is unique to this entity type. Manual – users must enter IDs manually. |
Allow Users to Create Entities* | On / Off | On – users can create entities of this type. Off – creation is restricted (e.g., only via workflow or admin). |
Requires Due Date* | On / Off | On – documents must have a due date. Off – due date not required. |
Requires Classified Access* | On / Off | On – access limited to assigned users or those with classified access. Off – any user with general access to this entity can view documents. |
Requires a Change Request for Changes* | On / Off | On – draft changes require an approved Change Request before creation. Off – drafts can be created without a Change Request. |
📎 References:
Tips
💡 Prefer Local numbering when different record types should not share the same sequence (e.g., SOP-0001 vs. CAPA-0001).
💡 Enable Requires a Change Request for Changes for any GxP-impacting documents to maintain traceable, approved changes.
💡 Use Classified Access for sensitive records (e.g., supplier audits, employee training records).