> For the complete documentation index, see [llms.txt](https://docs.labii.com/llms.txt). Markdown versions of documentation pages are available by appending `.md` to page URLs; this page is available as [Markdown](https://docs.labii.com/applications/quality-management-system-qms/quality-management-system-qms.md).

# Quality Management System (QMS)

## Overview

Maintaining rigorous quality standards is essential in regulated industries where product safety, regulatory compliance, and operational excellence are non-negotiable. The [Quality Management System (QMS)](https://www.labii.com/products/quality-management-system-qms) application built on Labii provides a centralized, audit-ready platform for managing all quality-related activities—from controlled document management to audit execution and CAPA tracking.

Labii's QMS application replaces fragmented paper-based or spreadsheet-driven quality processes with an integrated digital system. Each core quality function—document control, non-conformance reporting, CAPA, change control, and audits—has a dedicated table with structured workflows, role-based access, and full audit trails. The system supports compliance with ISO 9001, ISO 13485, FDA 21 CFR Part 11, GMP, and GLP requirements, making it suitable for pharmaceutical, biotechnology, medical device, and clinical laboratory environments.

{% hint style="info" %}
This application is ideal for organizations operating under regulatory frameworks such as ISO 9001, ISO 13485, FDA 21 CFR Part 820, or ICH Q10, where documented evidence of quality processes is mandatory.
{% endhint %}

## Use Cases

### Pharmaceutical and Biotech Manufacturing

* Maintain a controlled document library for SOPs, work instructions, and policies
* Track deviations and out-of-specification (OOS) events through non-conformance records
* Manage CAPA workflows from root cause analysis to effectiveness verification
* Control manufacturing process changes with documented risk assessments
* Plan and execute internal audits against GMP requirements

### Medical Device Companies

* Manage design history files and quality records per ISO 13485
* Track product non-conformances and customer complaints
* Drive corrective actions linked to specific non-conformance events
* Document and approve changes to device specifications or processes
* Conduct supplier audits and internal quality system audits

### Clinical and Diagnostic Laboratories

* Maintain accreditation-required SOPs and quality manuals
* Document laboratory non-conformances and corrective actions
* Track CAPA effectiveness and closure timelines
* Manage equipment change controls with validation records
* Support CAP, CLIA, and ISO 15189 audit preparedness

### Academic and Contract Research Organizations

* Standardize quality documentation across multiple studies
* Document GLP deviations with corrective actions
* Manage sponsor audit preparation and responses
* Control SOP versioning and training records
* Track quality metrics and trends over time

### Food and Consumer Products

* Manage food safety plans, HACCP documentation, and SOPs
* Track non-conformances from raw material receipt through finished product
* Drive supplier corrective action requests (SCARs)
* Document and control formula or process changes
* Conduct internal audits aligned with FSMA or ISO 22000 requirements

## Getting Started

{% stepper %}
{% step %}
Navigate to **Settings → Applications** from the main menu
{% endstep %}

{% step %}
Click **Add application** and select **Add from a template**
{% endstep %}

{% step %}
Choose **Quality Management System (QMS)** from the template list

{% hint style="warning" %}
If the QMS option is not available, it may already be installed in your account. Check the side menu for the QMS tables.
{% endhint %}
{% endstep %}

{% step %}
Wait for installation to complete. The system will automatically create five tables:

* **qms\_document** — Controlled document library
* **qms\_nonconformance** — Non-conformance reports
* **qms\_capa** — Corrective and preventive actions
* **qms\_change\_control** — Change control records
* **qms\_audit** — Audit planning and execution
  {% endstep %}

{% step %}
Access the newly created QMS tables from the side menu and begin configuring your quality workflows
{% endstep %}
{% endstepper %}

## Application Structure

### QMS Document Table

The **qms\_document** table serves as the controlled document repository for your quality management system.

**Purpose**: Maintain versioned, approved quality documents including SOPs, work instructions, policies, and forms

**Typical Use**: SOP lifecycle management, document approval workflows, controlled distribution, periodic review scheduling

***

### QMS Non-Conformance Table

The **qms\_nonconformance** table captures deviations, defects, complaints, and quality failures.

**Purpose**: Record, investigate, and disposition non-conforming products, events, or processes

**Typical Use**: Manufacturing deviations, OOS results, customer complaints, supplier non-conformances, laboratory errors

***

### QMS CAPA Table

The **qms\_capa** table manages corrective and preventive actions from initiation through effectiveness verification.

**Purpose**: Drive systematic resolution of quality issues and prevent recurrence through structured root cause analysis and action tracking

**Typical Use**: Corrective actions linked to non-conformances, preventive actions from trend analysis, audit findings remediation

***

### QMS Change Control Table

The **qms\_change\_control** table documents and approves changes to processes, equipment, materials, and systems.

**Purpose**: Evaluate risk, obtain approvals, and implement changes in a controlled and traceable manner

**Typical Use**: Process changes, equipment qualifications, formulation changes, software updates, facility modifications

***

### QMS Audit Table

The **qms\_audit** table manages the full audit lifecycle from planning through closure.

**Purpose**: Plan, execute, document findings, and track responses for internal and external audits

**Typical Use**: Internal QMS audits, supplier audits, regulatory inspection preparation, mock audits

## Creating a Controlled Document

{% stepper %}
{% step %}
Navigate to the **qms\_document** table from the side menu
{% endstep %}

{% step %}
Click **+ Add** to create a new document record
{% endstep %}

{% step %}
Fill in the document details:

* **Name**: Document title
* **Document number**: Unique identifier (e.g., SOP-0001)
* **Document type**: SOP, Work Instruction, Policy, Form, etc.
* **Owner**: Responsible department or individual
* **Effective date**: When the document becomes active
  {% endstep %}

{% step %}
Attach the document file using the **Files** section widget and enter the document content or link to an external source
{% endstep %}

{% step %}
Route the document for review and approval using the **Signature** widget to capture electronic signatures from designated reviewers and approvers
{% endstep %}

{% step %}
Once all signatures are collected, update the document status to **Approved** and set the next scheduled review date
{% endstep %}
{% endstepper %}

{% hint style="info" %}
Labii's electronic signature functionality supports 21 CFR Part 11 compliance requirements for electronic records and signatures.
{% endhint %}

## Reporting a Non-Conformance

{% stepper %}
{% step %}
Navigate to the **qms\_nonconformance** table from the side menu
{% endstep %}

{% step %}
Click **+ Add** to open a new non-conformance report
{% endstep %}

{% step %}
Enter the event details:

* **Name**: Brief description of the non-conformance
* **Date detected**: When the issue was identified
* **Detected by**: Person who identified the issue
* **Event type**: Deviation, OOS result, complaint, audit finding, etc.
* **Description**: Detailed account of what occurred and where
  {% endstep %}

{% step %}
Assign the record to the responsible owner for investigation and set the target closure date
{% endstep %}

{% step %}
Document the investigation findings, immediate containment actions taken, and the impact assessment
{% endstep %}

{% step %}
Determine disposition (Accept, Reject, Rework, Return) and update the record status accordingly
{% endstep %}

{% step %}
If a CAPA is required, create a linked CAPA record from the **qms\_capa** table referencing this non-conformance
{% endstep %}
{% endstepper %}

## Managing a CAPA

{% stepper %}
{% step %}
Navigate to the **qms\_capa** table from the side menu
{% endstep %}

{% step %}
Click **+ Add** to initiate a new CAPA record
{% endstep %}

{% step %}
Complete the CAPA header information:

* **Name**: Clear title of the CAPA
* **CAPA type**: Corrective (CA) or Preventive (PA)
* **Source**: Linked non-conformance, audit finding, trend analysis, or customer complaint
* **Assigned to**: CAPA owner responsible for execution
* **Target completion date**: Deadline for full CAPA closure
  {% endstep %}

{% step %}
Document the root cause analysis using an appropriate methodology (5-Why, Fishbone/Ishikawa, Fault Tree). Record findings in the **Root Cause** section
{% endstep %}

{% step %}
Define the action plan with specific, measurable corrective or preventive actions, assigning each action to responsible individuals with due dates
{% endstep %}

{% step %}
As actions are completed, update each action status and attach supporting evidence (e.g., updated SOPs, training records, test results)
{% endstep %}

{% step %}
After all actions are complete, document the **Effectiveness Check** results—verifying that the root cause has been eliminated—and close the CAPA
{% endstep %}
{% endstepper %}

{% hint style="warning" %}
Do not close a CAPA before the effectiveness check period has elapsed. Premature closure is a common audit finding in regulated environments.
{% endhint %}

## Submitting a Change Control

{% stepper %}
{% step %}
Navigate to the **qms\_change\_control** table from the side menu
{% endstep %}

{% step %}
Click **+ Add** to create a new change control request
{% endstep %}

{% step %}
Describe the proposed change:

* **Name**: Brief title of the change
* **Change type**: Process, equipment, material, software, facility, or document
* **Reason for change**: Business or technical justification
* **Description of change**: Detailed explanation of what will change and how
  {% endstep %}

{% step %}
Complete the risk assessment section:

* Identify potential risks introduced by the change
* Assess impact on product quality, safety, and regulatory status
* Determine if validation, qualification, or re-testing is required
  {% endstep %}

{% step %}
Route the change request through the approval workflow, collecting electronic signatures from required reviewers (QA, regulatory, operations, etc.)
{% endstep %}

{% step %}
Upon approval, implement the change according to the approved plan and attach all implementation evidence (updated documents, qualification records, training records)
{% endstep %}

{% step %}
Verify implementation completeness, update related documents (SOPs, specifications), and close the change control record
{% endstep %}
{% endstepper %}

## Planning and Conducting an Audit

{% stepper %}
{% step %}
Navigate to the **qms\_audit** table from the side menu
{% endstep %}

{% step %}
Click **+ Add** to create a new audit record
{% endstep %}

{% step %}
Define the audit scope:

* **Name**: Audit title
* **Audit type**: Internal, supplier, regulatory mock, or external
* **Audit scope**: Systems, processes, or departments to be audited
* **Audit criteria**: Applicable standards (ISO 9001, GMP, FDA 21 CFR, etc.)
* **Planned dates**: Start and end dates for the audit
* **Lead auditor**: Person responsible for conducting the audit
  {% endstep %}

{% step %}
Attach the audit plan, checklists, and any pre-audit questionnaires to the record using the **Files** section
{% endstep %}

{% step %}
During the audit, document observations and evidence in the record. Create linked **qms\_nonconformance** records for any findings requiring formal non-conformance reports
{% endstep %}

{% step %}
After the audit, compile the audit report and attach it to the record. Communicate findings to the auditee and assign responses
{% endstep %}

{% step %}
Track auditee responses and initiate CAPAs for major and minor findings as needed. Close the audit record once all responses are accepted
{% endstep %}
{% endstepper %}

## Advanced Features

### Linking Quality Records Across Tables

Labii allows you to cross-reference quality records between tables, creating a traceable quality chain. For example, a non-conformance can be linked to its source CAPA, which in turn references the corrective action's updated SOP in the document table.

{% hint style="info" %}
Use the **Record Link** column widget to create navigable links between related quality records across QMS tables.
{% endhint %}

### Metrics and Trend Analysis

Use Labii's dashboard and reporting features to monitor key quality metrics:

* Number of open non-conformances by type, department, or product
* CAPA aging and on-time closure rates
* Audit finding trends by category or area
* Change control cycle times and approval lead times

### Role-Based Access Control

Configure table-level and record-level permissions to enforce separation of duties required in regulated environments:

* Restrict who can initiate, investigate, approve, and close quality records
* Limit document editing to document owners while allowing read access for all users
* Ensure auditors can view but not modify records under review

### Notifications and Escalations

Configure automated notifications to alert team members when:

* A quality record is assigned to them
* A record is approaching its target completion date
* A document is due for periodic review
* An approval signature is requested

## Troubleshooting

### Issue: Cannot close a non-conformance or CAPA record

**Symptoms**: The record status cannot be updated to "Closed" or the close action is not available

**Solution**:

{% stepper %}
{% step %}
Verify that all required fields are completed—open or empty mandatory fields will block status transitions
{% endstep %}

{% step %}
Check that all linked action items within the CAPA record have been marked as complete
{% endstep %}

{% step %}
Confirm that your user role has permission to close records. Contact your QMS administrator if access is restricted
{% endstep %}
{% endstepper %}

### Issue: Document approval workflow is not progressing

**Symptoms**: A document remains in "Pending Approval" status after reviewers have been notified

**Solution**:

{% stepper %}
{% step %}
Confirm that all required reviewers have received and can access the notification. Resend notifications from the record if needed
{% endstep %}

{% step %}
Check whether the reviewer's Labii account is active and that they have the appropriate table access permissions
{% endstep %}

{% step %}
If a reviewer is unavailable, work with your QMS administrator to reassign the approval to a qualified delegate per your quality procedures
{% endstep %}
{% endstepper %}

### Issue: Cannot find a previously approved document

**Symptoms**: A controlled document is not visible in the qms\_document table

**Solution**:

{% stepper %}
{% step %}
Check the table filters—documents may be filtered by status. Remove any active filters or add "Archived" to the status filter to reveal retired documents
{% endstep %}

{% step %}
Use the search bar to search by document number or title
{% endstep %}

{% step %}
If the document was archived, open the record and check the version history to access previous revisions
{% endstep %}
{% endstepper %}


---

# Agent Instructions
This documentation is published with GitBook. GitBook is the documentation platform designed so that both humans and AI agents can read, navigate, and reason over technical content effectively. Learn more at gitbook.com.

## Querying This Documentation
If you need additional information that is not directly available in this page, you can query the documentation dynamically by asking a question.

Perform an HTTP GET request on the current page URL with the `ask` query parameter:

```
GET https://docs.labii.com/applications/quality-management-system-qms/quality-management-system-qms.md?ask=<question>
```

The question should be specific, self-contained, and written in natural language.
The response will contain a direct answer to the question and relevant excerpts and sources from the documentation.

Use this mechanism when the answer is not explicitly present in the current page, you need clarification or additional context, or you want to retrieve related documentation sections.