Quality Management System (QMS)
Use Labii as a Quality Management System (QMS) to manage and track quality-related processes, including document control, non-conformance management, corrective and preventive actions (CAPA), and audi
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) 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.
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.
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
Navigate to Settings → Applications from the main menu
Click Add application and select Add from a template
Choose Quality Management System (QMS) from the template list
If the QMS option is not available, it may already be installed in your account. Check the side menu for the QMS tables.
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
Access the newly created QMS tables from the side menu and begin configuring your quality workflows
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
Navigate to the qms_document table from the side menu
Click + Add to create a new document record
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
Attach the document file using the Files section widget and enter the document content or link to an external source
Route the document for review and approval using the Signature widget to capture electronic signatures from designated reviewers and approvers
Once all signatures are collected, update the document status to Approved and set the next scheduled review date
Labii's electronic signature functionality supports 21 CFR Part 11 compliance requirements for electronic records and signatures.
Reporting a Non-Conformance
Navigate to the qms_nonconformance table from the side menu
Click + Add to open a new non-conformance report
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
Assign the record to the responsible owner for investigation and set the target closure date
Document the investigation findings, immediate containment actions taken, and the impact assessment
Determine disposition (Accept, Reject, Rework, Return) and update the record status accordingly
If a CAPA is required, create a linked CAPA record from the qms_capa table referencing this non-conformance
Managing a CAPA
Navigate to the qms_capa table from the side menu
Click + Add to initiate a new CAPA record
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
Document the root cause analysis using an appropriate methodology (5-Why, Fishbone/Ishikawa, Fault Tree). Record findings in the Root Cause section
Define the action plan with specific, measurable corrective or preventive actions, assigning each action to responsible individuals with due dates
As actions are completed, update each action status and attach supporting evidence (e.g., updated SOPs, training records, test results)
After all actions are complete, document the Effectiveness Check results—verifying that the root cause has been eliminated—and close the CAPA
Do not close a CAPA before the effectiveness check period has elapsed. Premature closure is a common audit finding in regulated environments.
Submitting a Change Control
Navigate to the qms_change_control table from the side menu
Click + Add to create a new change control request
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
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
Route the change request through the approval workflow, collecting electronic signatures from required reviewers (QA, regulatory, operations, etc.)
Upon approval, implement the change according to the approved plan and attach all implementation evidence (updated documents, qualification records, training records)
Verify implementation completeness, update related documents (SOPs, specifications), and close the change control record
Planning and Conducting an Audit
Navigate to the qms_audit table from the side menu
Click + Add to create a new audit record
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
Attach the audit plan, checklists, and any pre-audit questionnaires to the record using the Files section
During the audit, document observations and evidence in the record. Create linked qms_nonconformance records for any findings requiring formal non-conformance reports
After the audit, compile the audit report and attach it to the record. Communicate findings to the auditee and assign responses
Track auditee responses and initiate CAPAs for major and minor findings as needed. Close the audit record once all responses are accepted
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.
Use the Record Link column widget to create navigable links between related quality records across QMS tables.
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:
Verify that all required fields are completed—open or empty mandatory fields will block status transitions
Check that all linked action items within the CAPA record have been marked as complete
Confirm that your user role has permission to close records. Contact your QMS administrator if access is restricted
Issue: Document approval workflow is not progressing
Symptoms: A document remains in "Pending Approval" status after reviewers have been notified
Solution:
Confirm that all required reviewers have received and can access the notification. Resend notifications from the record if needed
Check whether the reviewer's Labii account is active and that they have the appropriate table access permissions
If a reviewer is unavailable, work with your QMS administrator to reassign the approval to a qualified delegate per your quality procedures
Issue: Cannot find a previously approved document
Symptoms: A controlled document is not visible in the qms_document table
Solution:
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
Use the search bar to search by document number or title
If the document was archived, open the record and check the version history to access previous revisions
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