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Document Controls: Editing Control Numbers, Effective Dates, and Review Dates on Approved Documents

Workspace Managers can use the Document Controls tab in Manager Mode to edit a document's control number, effective date, review-by date, and periodic review date on approved documents without creating a new version.

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Written by Casey Huxtable

Required Role: Workspace Manager (Manager Mode)

Applies to: Approved documents

Availability: Must be enabled for your organisation by Kivo Support

Document Controls allows Workspace Managers to update a document's control number, effective date, review-by date, and periodic review date directly on an approved document without creating a new version or going through a full workflow cycle. Every change requires a reason and is recorded in the document's audit trail.


Overview

In regulated environments, certain document metadata fields, particularly control numbers and version label dates, occasionally need to be corrected or updated without changing the document's content. Document Controls provides a dedicated interface for making these updates and is available exclusively in Manager Mode on the document's Controls tab.

Every change requires a documented reason and is recorded in the document's audit trail, helping support traceability requirements under 21 CFR Part 11, EU Annex 11, and ISO 13485.


Available ControlFields

The following fields are editable via Document Controls when they have been set on the document:

Field

Description

Reason category required

Control Number

The document's unique identifier or sequence number. The field label may be customised in your workspace (e.g. "SOP Number", "Document ID").

Document Control Number Change

Effective Date

The date from which the current approved version is considered in effect.

Version Label Change

Review By

The date by which the document must next be reviewed.

Version Label Change

Periodic Review Date

The date after which the document becomes eligible for a periodic review cycle.

Version Label Change

Note: Only fields that have already been set on the document are displayed in the Controls tab. If a document has no control number or version label dates, the tab will show a message that no controls are set.


How To Edit Document Controls

Document Controls is only accessible in Manager Mode. Ensure Manager Mode is active before following these steps.

  1. Open the document you want to update.

  2. In the Manager Mode navigation, select the Controls tab.

  3. Click the field you want to edit (Control Number, Effective Date, Review By, or Periodic Review Date). Each field has an inline edit button.

  4. In the edit modal, update the value and select a reason from the dropdown. If no predefined reason fits, enter a custom reason in the text field.

  5. Click Update to save the change.

The change takes effect immediately and is recorded in the document audit trail with the acting user's name and the reason provided.


When Document Controls is Available

The Controls tab is only shown when all of the following conditions are met:

  • The Document Controls feature is enabled for your organization

  • You are in Manager Mode

  • The document has at least one approved version

The Controls tab will not appear, or will show a disabled message, in any of these situations:

Situation

Behaviour

Document has no approved version

Tab is hidden; message shown: "Document controls are available on approved documents"

Document is an alias

Tab shows: "Document controls are managed on the source document." Edit from the source document instead.

Document has been deleted

Tab shows deletion date; editing is not available

Manager Mode is not active

Controls tab does not appear


Reason Definitions

Every Document Controls edit requires a reason. Reason options come from two configurable categories in your workspace:

  • Document Control Number Change: Used when editing the Control Number field.

  • Version Label Change: Used when editing Effective Date, Review By, or Periodic Review Date.

Workspace Managers can configure the available options for both categories in Workspace Settings > Reason Definitions. Each category supports predefined reasons and a free-text "Other" option.


Audit Trail

All Document Controls changes are recorded in the document's audit trail. Each entry includes:

  • The name of the Workspace Manager who made the change

  • The field that was updated

  • The old and new values

  • The reason selected or entered

  • A timestamp

This record is immutable and can be reviewed at any time via the document's Audits tab in Manager Mode or by users with appropriate access.


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