---
title: "Quality order approval and validation"
slug: "quality-order-approval-and-validation"
description: "Manage quality order approval and validation processes to support GMP compliance, controlled reviews, and efficient batch release."
tags: ["Life Sciences", "Quality Control and Assurance"]
updated: 2026-06-29T06:56:28Z
published: 2026-06-29T06:56:28Z
canonical: "docs.staedean.com/quality-order-approval-and-validation"
---

> ## Documentation Index
> Fetch the complete documentation index at: https://docs.staedean.com/llms.txt
> Use this file to discover all available pages before exploring further.

# Quality order approval and validation

From a GMP perspective, the approval and validation of quality orders are critical steps. According to GMP guidelines, these activities require at least two sign-offs.

When all results have been entered and reviewed, quality orders should go through an approval process and a final validation step corresponding to the release/rejection of the batch. The approval process can consist of multiple steps depending on the type of material; for example, the release of finished pharmaceutical products must be approved by the quality control manager and quality assurance officers.

While standard Microsoft Dynamics 365 Finance & Supply Chain Management provides a single step for validating quality orders and consequent batch release, Life Sciences Quality Control & Assurance allows configuring a [quality order approval workflow](/life-sciences/docs/quality-order-approval-workflow). If the approval workflow is in place, quality orders can be submitted for approval using the **Submit** button (**Workflow > Submit**) in the **Quality orders** form; the workflow engine will then update the status to **Submitted** and propose the next task.

The workflow history can be viewed by clicking **Actions > View history**.

When the workflow is completed, the state is set to **Completed**. From this moment on, authorized users can validate the quality order by pressing the **Validate** button.

Life Sciences Quality Control & Assurance allows to secure quality order validation through electronic signature. If the [electronic signature requirement](/life-sciences/docs/electronic-signature-requirements) for quality order validation is active, the **Sign document** form is displayed when clicking the **Validate** button. Users need to:

1. Enter a **Reason code** (for example, “QC approval”) and a comment (optional/mandatory according to the electronic signature parameters), then click **OK**.
2. Enter the electronic signature **Password** and click **OK**.

> [!NOTE]
> Note
> 
> The electronic signature leverages Microsoft Dynamics 365 Finance & Supply Chain Management standards, enhanced by STAEDEAN Life Sciences features available in the Life Sciences Supply Chain Management module:

- [Electronic signature password expiration](/life-sciences/docs/validity-period-for-the-electronic-signature-certificate)
- [Failed signatures log](/life-sciences/docs/failed-signatures-log)
- [User lock-out](/life-sciences/docs/user-lock-out)
- [Advanced database logging](/life-sciences/docs/advanced-database-logging)

> [!NOTE]
> Note
> 
> In D365 F&SCM, version 10.0.45, Microsoft has introduced the “Electronic signature improvements” feature, which includes the “Validate quality order” build-in electronic signature requirement. This new standard functionality overlaps with the process previously described. When the “Electronic signature improvements” feature is enabled in **Feature management**, the STAEDEAN “Quality order validation” electronic signature requirement **will be hidden**, and the corresponding Microsoft functionality should be used instead.

Upon validation of a quality order, authorized users can also force the order status (for example, force the status to **Pass** even if one result is out of specifications). This can be done by selecting the desired status in the **Force status** field.

Validated quality orders can’t be changed. To make adjustments, click **Reopen quality order**, which sets the status to **Open** and resets the workflow to **Not submitted**. You must reprocess approval before validation, ensuring all changes go through proper review.

The approval process for initial and reopened quality orders can be distinguished by configuring conditional decisions in the workflow, utilizing the **Reopen** field. For instance, first-time approvals may require multiple stages and a more comprehensive workflow, whereas approvals following a reopening can be assigned a streamlined process.

## Related

- [Quality order approval workflow](/quality-order-approval-workflow.md)
- [Electronic signature requirements](/electronic-signature-requirements.md)
- [Validity period for the electronic signature certificate](/validity-period-for-the-electronic-signature-certificate.md)
- [Failed signatures log](/failed-signatures-log.md)
- [User lock-out](/user-lock-out.md)
- [Advanced database logging](/advanced-database-logging.md)