{"id":8665,"date":"2022-11-30T10:43:16","date_gmt":"2022-11-30T10:43:16","guid":{"rendered":"https:\/\/slcontrols.com\/smart-manufacturing-solutions-and-the-importance-of-data-integrity\/"},"modified":"2022-11-30T10:43:16","modified_gmt":"2022-11-30T10:43:16","slug":"smart-manufacturing-solutions-and-the-importance-of-data-integrity","status":"publish","type":"post","link":"https:\/\/www.slcontrols.k8s-stg1-global.sq1.io\/en\/smart-manufacturing-solutions-and-the-importance-of-data-integrity\/","title":{"rendered":"Smart Manufacturing Solutions and the Importance of Data Integrity"},"content":{"rendered":"

Transforming your life sciences facility into a factory of the future involves implementing smart manufacturing solutions<\/a> as part of a digitalization strategy<\/a>. Those solutions will ensure you get the benefits of digitalized processes while establishing the foundations for the next stage of your journey. There will be challenges, however, and one of the most important is data integrity.<\/p>\n

Without a clear data plan that prioritizes data integrity in every workflow, process, and system, your smart manufacturing solutions will struggle to reach their full potential. They could even fail.<\/p>\n

Problems with data integrity and how you use data in your facility can also have wider consequences, whether related to a new smart manufacturing solution or not. We can see this in a study that analyzed warning letters issued to pharmaceutical manufacturers by the FDA<\/a>. The researchers looked at warning letters issued between 2010 and 2020 and found that 21 percent involved data integrity issues. Only process validation had a greater number of citations.<\/p>\n

In other words, data and data integrity are crucial to the systems and processes you use today.<\/p>\n

Data and data integrity are also essential for ensuring the successful implementation of the smart manufacturing solutions that will optimize your systems and processes for the future.<\/p>\n

What Is Data Integrity?<\/h2>\n

To understand what data integrity means in the life sciences sector, we can turn to draft guidance published by the FDA in 2016 \u2013 Data Integrity and Compliance With CGMP<\/a>.<\/p>\n

\u201cFor the purposes of this guidance, data integrity refers to the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA).\u201d<\/p><\/blockquote>\n

You can read more about ALCOA and ALCOA+ on our blog<\/a>.<\/p>\n

So, data integrity is about having data that is trustworthy and reliable. Only by having reliable and trustworthy data can you get the most out of technologies like digital twins and machine learning. High-quality data is also essential to maximize the potential of your MES and ERP systems<\/a>, and it is a main focus of GxP.<\/p>\n

The Risks of Manual Data Interventions<\/h2>\n

Manual data intervention is one of the biggest issues with data integrity in pharmaceutical and medical device companies. Manual data interventions can take many forms, including when operators manually collect, store, update, and\/or transfer data. If there is a manual intervention in any of these processes, problems can occur:<\/p>\n