DatStat Online Seminars
Surviving an Audit – Compliance vs. Validation
held November 2013
Founder & Consultant
Computer System Validation
Sr. Director, Healthcare Solutions
It’s time for an FDA audit. Will your site pass the test?
Clinical trial sponsors need to know that each of their sites is operating according to protocol, GCP, and FDA requirements. Likewise, sites and CROs interested in attracting new studies must demonstrate their ability to meet these requirements. Validation is the fastest, most affordable way for everyone to be assured that trials are fully-compliant.
David Nettleton, author and FDA compliance expert, detailed the 14-step process used to validate computer systems used in clinical trials and explain the roles that vendors, sites, and sponsors must play in the process. Next, Renee Petrie of DatStat discussed how the validation process supports the drive to reduce study duration and lower costs.
- Understanding 21 CFR Part 11 vs GCP
- Security requirements for EDC/CDMS software
- ROI of compliance and validation
- Beyond software – other requirements for validation
- Roadmap for compliance
Following the session, participants were invited to participate in an overview of the validated EDC/CDMS technology and services provided by DatStat.