2021 - Implementing a Robust Data Integrity Program

Topic 1: Regulatory Guidance Review
FDA (CFR)
EU (EurdraLex)
PIC/S
Topic 2: Review all Elements Important to Maintaining Data Integrity
The ALCOA+ criteria for data integrity
Data life cycle in the process workflow – managing controls
Paper versus electronic systems
Validation of computerized systems for data integrity controls
Topic 3: Key Data Integrity Topics
Recording results on paper. Good Documentation Practices
Audit trail
Data review
File format
Storage media
Encryption
User management (access control)
Review of the data life cycle
Handling of raw data
Unauthorized access
Appropriate access privileges for each user role
Is my chromatographic system ready? Role of “test” injections
Audit trails – options for older systems
Manual chromatographic integration
Standalone versus network systems
Protecting electronic records of standalone systems
Topic 4: What are GMP-relevant Data?
GMP-relevant data – what are GMP-relevant data?
Identifying data that has been changed or modified – how the system can help
Review by exception – how technical controls can help
Have you specified and validated these functions?
Topic 5: Why Is An Audit Trail Review Important?
Suspected data integrity violation - What do we need to do?
Topic 6: Can Spreadsheets meet Data Integrity requirements?
Problems with spreadsheets
Good Practice for using spreadsheets in a regulated environment
Building data integrity features into a spreadsheet
Topic 7: Common problems from FDA 483 observations and warning letters and how to avoid them
Case Study 1: Audit Trail to Review?
Attendees will be presented with an overview of the audit trails within an application and the content of each one. Which audit trails should be reviewed and when?
Attendees will be provided with the output of an audit trail to review and see if any potential issues are identified for further investigation.
Attendees will be presented with a list of records to identify if they are GMP records. Examples from production, laboratory and QA examples of GMP-relevant data will be provided.