Traditionally, PK Scientists have operated with locally installed applications to resume their PK analysis. In this environment the computer system was under control of the local IT department who would provide all necessary documentation expected by regulatory authorities to provide evidence that their computer system is CFR part 11 compliant.
In the new world of cloud-based applications like Phoenix Hosted or Integral this situation changes. As PK scientists transition to SaaS applications, vendors like Certara play a crucial role in validating the computer system. The expertise of the vendor is essential to ensure compliance and mitigate the risk of potential costly penalties and delays in the drug development process that could result from audits by authorities.
In this webinar, our experienced industry experts Dave Baker and Clive Rich explore compliance requirements for research organizations and provide a detailed overview of the computer system validation process for SaaS.
Webinar attendees will learn:
– Why is compliance important?
– What is different for the validation of SaaS systems ?
– What are the advantages for the customer?
– What are the latest trends in compliance?
講演者David Baker, Clive Rich
