Category Archives: Data Integrity

Are your Data Management Policies supporting the GXP compliance?

Understanding the criticality of setting Master Data and Policies Your Data lifecycle extends across departments and its governance requires good practices to be followed. Understanding the criticality’s of setting common Master Data and policies is very important and extended educational efforts should be considered at corporate level. When implementing digital solutions for quality processes, GxP activities, the data management policies should apply to any computer software’s involved, all along the data lifecycle, data workflows and related processes, with particular attention to Read More...

How to be sure that your Data Integrity project has fully covered your eData LifeCycle?

The integrity of your Data along their lifecycle This is not another data integrity article, yet this is about demonstrating to auditors that you do have it all right and under control. So we’d like to highlight the importance of assessing the complete life cycle of your data and managing it for complete compliance to data integrity requirements. We’ve all attended the thousand trainings, webinars and presentation about Data Integrity recommendations and guidelines. We know by heart the ALCOA definition and Read More...

Data Integrity, Company Integrity: a Management Commitment

Thousands of documents and articles have been written about Data Integrity. You probably have already attended several presentations and webinars introducing the concept, repeating incessantly the list of data integrity guidelines published by the regulatory bodies and showing you frightening summaries of warning letters. Data integrity is not a new trend You know that data integrity is not a new concept. You know of multiple examples not even related to the pharma industries that had a strong impact in the society. Read More...