May 12, 2021
Regulatory Compliance
To invoke compliance with industry standards, regulators are consistently rising inspection 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 as loss of accreditation or even termination.
Implementing a Laboratory Information Management System (LIMS) software helps in resolve or even get ahead of this by automating laboratory processes and documentation but also with compliance and data management.
Laboratory Information Management System (LIMS) software offers control, manage, organise, document, analyse and report information and tools that are tailored to make sure of 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, 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 software, adherence to the latest standards and drives compliance and efficiency line up with the laboratory’s need.
The following three aspects of a LIMS helps laboratories comply with the regulatory guidelines and best practices.
A Laboratory Information Management System (LIMS) 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.
A LIMS 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. A LIMS also make it clear to set and monitor key performance indicators (KPIs), and to attain a clear cut view of laboratory processes.
A LIMS software grants to capture more details than capturing manually and maintains the data accuracy, by integrating with lab instruments and software. A Perfect LIMS takes things a step forward by flagging any items that fail specifications and avoids transcription errors completely because of automatic documentation.
Top LIMS 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 industries.
Want to learn more about our REVOL LIMS? Check out by a REVOL LIMS demo by mailing us at sales@revolsolutions.com to explore its features yourself.
LIMS Introduction
LIMS Benefits
LIMS and ISO17025
Choosing LIMS
LIMS Over Excel
Integrating Laboratory Instruments
Digital Laboratory
Inventory Management
RevolLIMS on Cloud
Laboratory Data Security