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Calendar of Events
| Date | Event Name |
|---|---|
| May 23, 2012 | Webinar: PBPK modeling |
Computer Systems Validation
XenoTech’s Computer Validation team maintains a comprehensive program of computerized system validation designed to maintain compliance with 21 CFR Part 11 regulations. We follow a traditional life cycle approach to validation, utilizing the concepts of IQ/OQ/PQ* that meet or exceed FDA software validation recommendations. We operate validated systems under change control, and when appropriate, maintain secure production environments.
Validating our computer processes provides confidence in the quality and reliability of the data that we generate. Our controlled and systematic approach to implementing periodic changes, such as necessary software upgrades, assures continuity within each study, and ensures the function of all systems as they were designed to operate.
*Installation Qualification, Operational Qualification, Performance Qualification (PQ is also known as “User Testing”.)
