Data integrity for computerized systems in GxP environment

The goal of the course

• Explore all aspects related to data integrity in the system's lifecycle

• Dive deep into data integrity aspects related to computer system validation based on GAMP 5 edition 5 and other guidelines

• Gather information about common data integrity findings from the FDA and local regulatory bodies

Scope of the course

Data integrity in system design

• Ensuring Data Integrity

• Accounts & Access Rights

• Data security

• Audit Trail

• Backup & Restore

Data integrity in system operation

• Operational Processes

• Periodic Review

• User Access Review, Account Usage Review

• Audit Trail Review

Data Integrity in System Retirement

• Migration

• Archival

• Destruction (Retention, Destruction)

Data Integrity Assessment

• Audit trail

• Reporting

• Backup and restore

• System Security

• Data storage and export

• Accounts & Access Rights

Data integrity for computerized systems refers to the accuracy, reliability, and consistency of data throughout its lifecycle. It ensures that data is complete, unaltered, and remains intact from the moment it is created or entered into a system until the time it is accessed, modified, or deleted. Maintaining data integrity is crucial for ensuring the trustworthiness and quality of information in computer systems, especially in sectors like healthcare, finance, and regulatory compliance where accurate data is essential for decision-making and compliance with regulations. Various measures, such as encryption, access controls, validation checks, and backup procedures, are employed to preserve data integrity in computerized systems.