LAB4ACTION is a comprehensive laboratory information management system (LIMS) that eliminates the need for paper data collection. It streamlines quality management by moving it from the laboratory to the production site. Organizations can avoid compromising the quality and consistency of the data captured. With LAB4ACTION the leaders in quality assurance create a transparent organization where all those involved have access to the checks, tests and data necessary to make sound decisions that directly affect operational quality.
DECIDE4ACTION uses The Food and Drug Administration’s (FDA) industry guidance and expectations for the role of data integrity in current good manufacturing practices (CGMP) as a measuring stick with which to design and evaluate our methods and processes. Our approach is that all data should be reliable, accurate, recorded, maintained and secure. Using the FDA and CGMP as our barometer, the recommended guidance and current regulations allow for risk-based, flexible strategies for organizations to prevent and detect issues with data integrity. Per the FDA via its final industry guidance, “Firms should implement meaningful and effective strategies to manage their data integrity risks based on their process understanding and knowledge management of technologies and business models.”
When considering how to meet many of these regulatory requirements, it may be useful to ask the following questions:
LAB4ACTION provides client-customization in order to not only address specific client needs such as terminologies, calculations, specifications, reporting and processes, but also to adapt to, address and conform to various industry compliance and regulatory requirements, i.e. FDA, ISO, SQF, CLIA, HIPAA, CFR Part 11, GDPR, MHRA, etc. DECIDE4ACTION solutions such as LAB4ACTION are designed to support organizations in meeting compliance and regulatory guidance associated with data management in temporary memory.
Below is how LAB4ACTION’s architecture, design and functionality addresses regulatory compliance demands: