Course Certificate

Data Integrity

Data integrity is one of the most important concepts in a GxP-oriented world. Without data - no product.

During the course, the participant has gained knowledge about:

• Key concepts and definitions within data integrity.
• Data versus data records and electronic records.
• Regulatory focus. What are the actual requirements? Culture, procedures, and technology.
• Frameworks for good data integrity, management, and key activities.
• Data lifecycle model.
• Risk assessment - learn to identify weak points in your own system.
• Data integrity - maturity and human factors in the company.
• Audit trails and data review.
• Inspection readiness within data integrity.
• GxP data integrity versus traditional IT record management.
• Data integrity and the URS.
• Process flow and data flow.
• Data integrity in the cloud world.
• Data archiving/retrieval (retention).
• Data migration.
• Hybrid systems - paper versus digital solutions.

Read more