According to clause 7.11 of the ISO/IEC 17025:2017 standard regarding data control and information management requirements, what does the laboratory need to do to ensure the compliance and effectiveness of the Laboratory Information Management System (LIMS)?
Many CNAS laboratories now use the LIMS system, but many laboratories do not know how to meet CNAS requirements. In fact, preparing the following materials is sufficient. Today, I will share them with you.
System Requirements Specification: Define the functional and performance requirements that LIMS must meet, including specific requirements for data collection, processing, storage, and retrieval.
System Verification and Validation Plan: Describe the process of verifying that the system meets predetermined requirements, including testing methods, acceptance criteria, and validation cycles.
User Acceptance Test Report: Record the test results of whether the system meets the expected functionality in the actual operating environment.
System Change Management Procedure: specifies the approval, documentation, and confirmation process for any modifications to LIMS (including software configuration and hardware upgrades).
Information Security Policy: Define data protection policies, including access permissions, data encryption, backup and recovery procedures.
Data Integrity Policy: A policy that ensures data integrity and accuracy, covering all stages of the data lifecycle.
Disaster recovery plan: includes data recovery steps and emergency response measures in case of system failure.
System operating procedures: Detailed description of the daily operation process of LIMS, including data input, output, maintenance, and exception handling.
Training records: Prove that all relevant employees have received appropriate training on the use and maintenance of LIMS.
Supplier Evaluation and Management Procedure: If LIMS is provided or maintained by external suppliers, there must be a procedure for evaluating and managing supplier qualifications and performance.
Regular audit and review records: including internal and external audit results, as well as evidence of continuous improvement of LIMS.
Data transmission and calculation inspection records: Prove the accuracy and consistency of data and calculations.
These documents not only help laboratories comply with ISO/IEC 17025 standards, but also serve as key tools for continuous improvement and maintenance of LIMS system quality.