Configuring Document Types

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 Document Type

Create the foundational category used to classify and manage records.

Go to Settings in the sidebar then select Document Types.
Click New Document Type.
Enter a name for the new document type.
Click Save.

💡 Tip: Use a clear, singular name (e.g., “Training Record”, “CAPA”, “SOP”).

Step 2: Configure Document 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 - Document IDs must be entered manually when creating the document.
Document ID Pattern*	Custom pattern	Defines the structure of the generated Document ID
Numbering formatting	On / Off	Includes leading zeros in the numeric portion of the ID to maintain a consistent fixed-width numbering format.
Enable document creation*	On / Off	Allows creating new documents from this document type.
Requires Due Date*	Hidden / Optional / Required	Defines whether the documents does require Due Date or not.
Limited to Classified Access*	Do not limit access / Limit to classified access	Any user with general access can access documents of this type. Only users with classified access can access documents of this type.
Require periodic review	On / Off	Defines whether the documents does require Periodic review or not.
Changes require a Change Request for Changes*	Yes / No	Yes – draft changes require an approved Change Request before creation. No – 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).