Data integrity is fundamental across numerous industries, but the terminology, practices, and language can often be complex and inconsistent. This article aims to clarify the concept of data integrity within laboratories and illustrate how LabWare LIMS canplay a vital role in ensuring accurate, reliable data, specifically addressing and mitigating regulatory concerns around dry-labbing.
6 min read
Leveraging LIMS to Enhance Data Integrity
By LabWare on 18 July 2024 11:37 AM
Topics: LIMS Regulatory Compliance Data Integrity
6 min read
Strategic Master Data Management for LIMS
By LabWare on 05 June 2024 10:41 AM
"Organizations without a solid data management strategy are on a collision course with catastrophe."
Thorton May, CIO Columnist
The consequences of poor data management are evident in many large firms, which often struggle with what is known as a "Major Data Mess." This term effectively captures the chaos from decades of accumulating data without a coherent strategy. These circumstances highlight the need for robust data quality practices and how an effective laboratory information management system (LIMS) master data management plan can shield your organization from similar problems. By adopting strong master data management, your lab can enhance operational efficiency, reduce costs, and avoid the issues of disorganized data.
A well-structured Master Data model, tailored to your business needs, can significantly accelerate the LIMS implementation process and set the system up for optimal success.
Topics: LIMS Laboratory Management Regulatory Compliance LabWare Services
8 min read
Navigating Data Integrity: The Importance of Authorized Data Changes
By LabWare on 29 May 2024 02:14 PM
Imagine a scenario where a simple software oversight could jeopardize your entire operation. A manufacturer of finished pharmaceuticals faced this unfortunate situation during a U.S. FDA inspection in April 2024. The investigatorobserved that the drug company lacked appropriate controls over its systems, allowing unauthorized changes to master production and control records. A commercial software used for microbiology documentation, integrating with barcode scanners to automatically populate sample locations, sample information, and time and date details, allowed analysts to override the scanner and make manual entries. Surprisingly, the software lacked an autosave function, leading to untracked changes and significant data integrity issues.