LIMS Role In Following Regulatory Compliance

May 12, 2021

Regulatory Compliance

An image displaying a banner with icons that drive regulatory compliance.

Introduction

To invoke compliance with industry standards, regulators are consistently raising inspections into labs and testing environments, including Chemical, Pharmaceutical, Healthcare Life Science, Forensic, Environmental and Testing & Calibration industries. A Non-compliance in audit findings may lead to severe consequences such as loss of accreditation or even termination.


Implementing a Laboratory Information Management System Software helps in resolving or even getting ahead of this by laboratory automation processes and documentation but also with compliance and data management.


Lab Information Management System offers control, manage, organize, document, analyze and report information and tools that are tailored to make sure proper information is captured and reported to meet the strict regulatory expectations.


Based on the industry the regulatory requirements changes, in which most generally familiar including ISO/IEC 17025:2017, GLP, HIPAA, EU GDPR, FDA 21 CFR Part 11, CLIA, ISO 15189:2012, ISO 20387, GCP, GLP, FSMA, HACCP, and ISBER Best Practices.


The lab managers should first observe the data integrity, focussed functionality and validation processes of a LIMS Solution, adherence to the latest standards and drive compliance and efficiency line up with the laboratory’s need.


Features of LIMS that drive compliance

The following three aspects of a Laboratory Management Software helps laboratories comply with the regulatory guidelines and best practices.

Organization
LIMS Organization

A Laboratory Information Management System Software is a web based application built around a centralized database which records and manages laboratory data and makes the data easily accessible includes sample data, test results, certificates of analysis (CoA), standard operating procedures (SOPs), study data, sample processing and storage data, workflows, and instruments associated with them. This not only allows a laboratory to remain organized, but also facilitates efficiency, transparency and compliance.

Visualization
LIMS Visualization

A Lab Management System helps lab managers and any other concerned lab members to report on sample testing and usage, and recommend optimizations where needed. The use of barcodes in LIMS attached to individual samples provides complete traceability throughout the sample life cycle and the electronically collected sample data makes it easy to compose into reports. Laboratory Management Software also makes it clear to set and monitor key performance indicators (KPIs), and to attain a clear cut view of laboratory processes.

Automation
LIMS Automation

A Laboratory Management System software grants to capture more details than capturing manually and maintains the data accuracy, by integrating with lab instruments and software. A Perfect Lab Management Solution takes things a step forward by flagging any items that fail specifications and avoids transcription errors completely because of automatic documentation.

Conclusion

Top Laboratory Information Management Systems Software providers working hard to assure compliance with regulatory best practices and guidelines for maintaining data integrity. By aiding with organization, visualization, automation and following the principles and best practices outlined by ISO/IEC 17025:2017, GLP, 21 CFR Part 11 LIMS software such as Revol LIMS can render compliance routine for any laboratory including Chemical, Petrochemical, Pharmaceutical, Healthcare, Life Science, Forensic, Environmental, Testing & Calibration Sectors.

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