Compliance with Data Integrity and Computerized System Validations


Data Integrity and Computerised System Validations (CSV) have become an area of increased scrutiny for regulatory agencies over the last several years. Understanding how the agencies view data integrity is critical for laboratories to maintain complete compliance. During this webinar, we investigated trends seen globally for data integrity violations and avenues for remediation. Defining how the agencies view CSV and approaching industry best practices for new instrumentation or remediation efforts to also comply with data integrity are outlined during this presentation.

In this webinar, we addressed different areas of concern and answer questions around:

  • How does the FDA view data integrity?
  • Why is data integrity so crucial?
  • What is metadata?
  • What is an audit trail?
  • Does each workflow on a computer system need to be validated?
  • What is Computer System Validation (CSV)?
  • How are CSV requirements met? – What are some of the pitfalls with CSV?
  • Are there best practices for the pharma lab?