What Is a Laboratory Quality Management System?
A laboratory quality management system (LQMS) is a solution that supports the control and improvement of laboratory processes to safeguard quality and product reliability. LQMS achieves this by managing resources, maintaining regulatory requirements, conducting evaluations, maintaining audit trail and training requirements, making continual improvements, and creating more efficient workflows for review and approval.
According to the World Health Organization, there are 12 essential building blocks LQMS systems focus on, many of which overlap.
These 12 LQMS building blocks, or quality system essentials (QSEs), include:
- Purchasing and inventory
- Process control
- Information management
- Documents and records
- Occurrence management
- Process improvement
- Customer service
- Facilities and safety
What Are Other Names for Laboratory Quality Management Systems?
A laboratory quality management system is sometimes referred to as:
- LQMS software
- LQMS system
- Laboratory QMS
- Laboratory QMS system
- Laboratory Management Information System
LQMS is not synonymous with a laboratory information management system (LIMS). Although both systems help manage lab operations and ensure regulatory compliance is met, they serve different functions:
A LIMS is used primarily by laboratory staff to manage daily data operations. LIMS provides digital execution and data tracking capabilities to automate data capture, tracking, and maintenance.
In contrast, an LQMS oversees actual quality policies and procedures in laboratories. This system requires policies and procedures for the lab following cGLP, whereas in the production areas there is also a QMS which helps the team adhere to cGMP for the QA requirements and supported QC activities.
LQMS provides boundaries, requirements, and guardrails that LIMS must adhere to and all operations within the lab which it supports. As such, it contains procedures for administration and usage of the LIMS by lab staff.
Why Is LQMS Important in Pharma?
A laboratory quality management system is important in pharma because it ensures laboratory results are correct, reliable, and timely.
LQMS supports the three laboratory phases:
- Pre-analytical: A sample is collected, received, registered, and processed by a lab.
- Analytical: Lab tests are performed and results are recorded.
- Post-analytical: Results are verified, reported, and archived.
These findings help inform the best course of action for a patient and allow healthcare providers or manufacturing professionals to make accurate diagnoses or batch decisions, respectively. As such, LQMS solutions protect patient wellbeing and safeguard diagnostic integrity.
Without laboratory quality management systems, patients might receive improper care or treatment, incorrect or untimely diagnoses, or inadvertently detrimental or faulty medication. The high accuracy rates provided by LQMS solutions help to build trust between patients and providers.
Laboratory quality management systems support the improvement of laboratory processes. These systems aim to minimize errors and improve quality by adhering to regulatory requirements, conducting ongoing evaluations, and creating more efficient workflows. As a result, they help improve patient outcomes and streamline lab testing.
By ensuring results are accurate, reliable, and timely, pharmaceutical organizations can use LIMS to maintain quality standards and protect patient outcomes at scale.