Implementing a Robust Data Integrity Program
Ms. Thomas, Vice President, Americas Quality Operations at Stallergenes Greer and has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes, and cleaning validation.
Utilizing strategic thinking, risk-based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.
Data integrity is defined as the maintenance of, and the assurance of the accuracy and consistency of, data over its entire life-cycle. Data Integrity is a global issue with both FDA and the European Regulatory Agencies majorly focusing on the topic during compliance inspections. Multiple FDA warning letters and EU GMP non-compliance reports have highlighted major data integrity failures and falsification within companies around the globe. The regulatory concern has been responded to by both domestic and foreign governing agencies with the FDA, EMA, MHRA, WHO, and PIC/S all having recently published data integrity standards and guidelines.
This webinar will detail a data integrity governance program and principles for defining quality and data integrity into processes and systems.
As regulators are focusing their inspection on data integrity, it is important that managers, supervisors, and users in regulated GMP laboratories understand the issues relative to data integrity and implement robust programs to ensure compliance.
Topic 1: Regulatory Guidance Review
- FDA (CFR)
- EU (EurdraLex)
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
- 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 is 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.
Course Level - Intermediate
Who Should Attend
- Quality Assurance
- Regulatory Affairs
- Operations Managers