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Drafting a Quality Document

Create and format the content of a Quality Document on your computer using the SimplerQMS Add-in, then check it back in so it’s ready for review and approval.

Updated over a week ago

Who Is This For?

  • Authors / Users — drafting and formatting document content

  • Document Controllers / QA — verifying draft readiness and metadata

  • Reviewers / Approvers — downstream review and approval after drafting

How to Do It?

Step 1: Check out the document

Click Check Out on the document. The file downloads to your computer.

📝 Note: While checked out, others can’t edit the file. Avoid long check-out times to reduce bottlenecks.


Step 2: Open and enable editing

Open the file in Microsoft Word (or the originating application). Click Enable Editing to start drafting.

💡Tip: If macros or protected view warnings appear, enable editing for this trusted file to use the add-in.


Step 3: Sign in to the SimplerQMS Add-in

In Word, go to SimplerQMS Add-ins and log in with your account.


Step 4: Draft and format your content

Write the content and apply formatting (headings, tables, images) per your document standards or template guidance.

📝 Tip: Use your organization’s standard sections (e.g., Purpose, Scope, Responsibilities, Procedure, Records) to keep consistency.


Step 5: Check in your changes from the add-in

From the SimplerQMS add-in, select Check In to upload your latest version and save your changes. Then Save and Close the document.

Compliance reminder: Always check in from the add-in to preserve version history and metadata. Emailing or locally saving does not update the controlled record.


Step 6: Send Document for Review (Skip if review is not required)

Select Send for Review at the bottom of the Properties card. The document state changes to Review and it’s assigned to the designated Reviewers.

Secondary actions (three-dots icon)

  • Send for Approval — Skips review; state changes to Approval and assigns it to Approvers. Requires Effective Date.

  • Archive — Removes from active use; state changes to Archived.

💡Tip: Enable track changes before sending the document for review.


Step 7: Send Document for Approval

The author prepares the document for approval and sends it to the assigned approvers.

  1. Set the Effective Date

    In the Properties card, set Effective Date.

    Required: You cannot send a document for approval without an Effective Date.

  2. Send for Approval

    In the Properties card, click the secondary icons (three dots icon) and select Send for Approval to route to assigned approvers. Enter a clear Version Description (what changed and why), then click Submit.

    The state changes to Approval, and the task is assigned to Approvers.

Secondary actions (three-dots icon)

  • Send back to Draft — if significant changes are needed; state changes to Draft.

  • Route for Another Review — initiates an additional review round; state changes to Review and assigns Reviewers.

Documents controlled by a Change Request

When a document is linked to a Change Request, the Effective Date field is not available on the document. The Effective Date from the Change Request is transferred to the document when the CR is closed (released).

📎 References:

Compliance Reminder: The Effective Date must be set before sending for approval — unless the document is controlled by a Change Request.


Tips

  • 💡 Draft from a template when possible to keep structure consistent and reduce rework.

  • 💡 Save early and often in Word before using Check In to avoid losing edits.

  • 💡 Keep the document checked out only while editing; check in promptly to enable collaboration and review.

What’s Next?

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