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Webinar preview: Compliance with data integrity and computerised system validations

Posted: 4 December 2018 | | No comments yet

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.

Compliance with data integrity and computerised system validations

During this webinar, our keynote speaker Margaret Blackburn, Global Head of Compliance Services at PerkinElmer, will be joining us to discuss how data integrity and computerised system validations (CSV) have become an area of increased scrutiny for regulatory agencies over the last few years. Understanding how the agencies view data integrity is critical for laboratories to maintain complete compliance.

Margaret will investigate trends seen globally for data integrity violations and avenues for remediation. She will look to defining how agencies view computerised system validations and will discuss how to approach the best practices for new instrumentation or remediation efforts to comply with data integrity during the presentation.

In this webinar, we will address 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?

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