How to Detect Lack of Data Integrity

Data are central to the development, manufacture and marketing of pharmaceuticals of all types. The renewed interest in data integrity raises questions regarding what is data integrity and how to assess it. Lack of data integrity comes in two forms: purposeful manipulation of the data to deceive and the inadvertent problems that occur in the production and analysis of data. Humans, equipment or both can be the source of the problem.

This session discusses both types of data integrity sources and introduces the assessment of “data pedigree” as a concept that puts focus on the types of data integrity issues and analytical and statistical methods for detecting data problems. Pharma and biotech case studies are used throughout the presentation to illustrate how the various approaches together.

Areas Covered in the Session :

• Understanding data integrity; what does it look like
• Case studies illustrating types and sources of data integrity issues
• Procedures for assessing data pedigree, integrity and quality
• Computer, analytical and statistical methods for evaluating data integrity and quality
• Limitations of observational data
• Guiding principles, tips and traps for the effective data integrity assessment

Who Will Benefit:

• Senior management
• Quality Assurance Team Members
• Quality Control Team Members
• Compliance Auditors
• Process Development Team Members
• Supply Chain and Logistics Managers
• Regulatory Affairs Team Members
• Engineering Staff
• IT Management and Staff working in regulated areas