The Life Sciences industry must manage massive amounts of information daily. Visibility into this data is essential to making business-critical decisions and a single error in your data can have a negative impact felt throughout the entire business. 

Data Integrity refers to the quality of the data concerning accuracy and consistency. Various organizations have tried to define standards and frameworks to define data integrity. Among these standards, the one defined by the U.S Food and Drug Administration (FDA) is called ALCOA+. 

The Importance of Data Integrity  

The FDA defines data integrity as the completeness, consistency and accuracy of data. Complete, consistent and accurate data should be attributable, legible, contemporaneously recorded, original and accurate, as well as complete, consistent, enduring and available (ALCOA+). 

Data integrity is an essential component of the industry’s responsibility to ensure the safety, efficacy and quality of products and is a fundamental element of effective quality management. 

Meeting ALCOA+ Standards  

The ALCOA+ principles set the standards for data integrity and are central to the FDA’s Current Good Manufacturing Practices (CGMP). Life Sciences manufacturers must meet the nine elements of ALCOA+ to be compliant. 

However, those using manual or siloed quality management processes will find meeting ALCOA+ standards challenging. This is because of the risks posed by manual systems like human error, duplicate entries and disparate data resulting from disconnected systems.  

Life Sciences manufacturers that use a digital, enterprise-wide quality management platform that integrates with other critical systems (like ERP, LIMS, MES) and automates processes will gain the visibility needed to meet each of the nine ALCOA+ principles.  

Immediate access to comprehensive and accurate data enables manufacturers to maintain regulatory compliance and identify and address issues faster to reduce costs, avoid recalls and ensure patient safety. 

A centralized, cloud-based system puts organizations in a position to achieve ALCOA+ compliance and reduce manual effort. Most importantly, it enables organizations to use the data efficiently to improve decision-making across the enterprise. 

Make Sure Your Data Is Telling the Whole Story  

Data-driven organizations understand the impact data has on their success. Lack of data integrity can lead to poor decision making, damage brand reputation, have a financial impact and affect product and patient safety. Ensure data integrity by following the ALCOA+ principles with the help of a digital quality management system (QMS). 

Read our most recent article published by MPO Magazine to learn more about how to achieve ALCOA+ compliance with a QMS.