Discover your Data – A Case Study on Data Flow Diagrams and Data Integrity

Learning Level: Intermediate
Time: 1000 - 1100 ET
Session Length: 1 hour

Data integrity is strengthened through a detailed understanding of your data – how it is created, where it is stored, what other data is relevant, and how and where the data is used within your business process. The need for such understanding is specifically called out in the July 2021 formal issue of the PIC/S PI 041-1 data integrity guidance as well as the GAMP Records and Data Integrity (RDI) series of Good Practice Guides.

GAMP RDI Good Practice Guide: Data Integrity by Design
GAMP RDI Good Practice Guide: Data Integrity - Key Concepts

This chromatography data system case study demonstrates how to gain understanding based on first building a map of data into and out of the system, and then focusing on defining the data flows within the system. As the map builds, any potential data integrity risks and process vulnerabilities become easily identifiable, facilitating a risk-based approach to process design, data integrity controls, and computerized systems validation.

Learning Objectives

  1. Learn how to build a data flow diagram across both a process and an individual computerized system
  2. Understand the concepts of data, metadata and supporting data
  3. Realize the impact of process and workflow complexity on the review process and potential for finding data integrity issues



Charlie C. Wakeham
APAC GxP Compliance Manager
Waters Corporation

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