ON-DEMAND WEBCAST: Why is Electronic CDS Data a Major Data Integrity Concern for Regulators?
“Testing into Compliance” or “Testing into Specification” is a critical quality issue that regulators have found occurs in many laboratories. The electronic data trails in modern CDS solutions have demonstrated that laboratories are often excluding data from GxP reports without scientific justification. Repeating testing without a formal investigation and invalidation is not allowed by regulations.
- As the WHO says, "Data integrity risks may occur when persons choose to rely solely upon paper printouts or PDF reports"
- Evidence of previous “unofficial testing” may not be included in the presented static reports
- Dynamic electronic records should include versions of results as well as audit trails
- Learn how to review both reported and “non-reported data” electronically
Key Learning Objectives:
- Good Manufacturing/Laboratory Practices specifically around electronic record compliance
- Data integrity concerns and expectations around the globe - including a summary of guidances available
- How this translates into chromatographic processes addressing the specific concerns of regulators
- How to transform a paper-based review process to an electronic process
Who Should Attend:
- Regulated companies: pharmaceutical, food, environmental
- Laboratory directors, managers, and analysts
- Information technology professionals supporting laboratory applications: managers, business system analysts
- Quality assurance professionals
Senior Marketing Manager, Informatics and Regulatory Compliance
As well as for internal education, Heather is also often called on to present on the latest Data Integrity observations to users of UNIFI, NuGenesis and Empower. Along with Waters Professional Services experts, Heather offers advice to users how to design Standard Operating Procedures and configure the applications to take advantage of the technical controls built into the applications.
Heather is also active in the ISPE GAMP Community of Practice and the ISPE New England Chapter where she is called on as an expert in Data Integrity, specifically around the chromatographic analysis process.