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Frontier Issues in Electronic Information Integrity Today
Session Chair(s)
Teri Stokes, PhD, MS, MT
Director, Quality Assurance Compliance
GXP International, United States
This symposium will address three different “on the edge” issues for electronic information integrity today.
• How do you evaluate whether validation is good business even if FDA hasn’t identified the system for GXP/Part 11 compliance?
• How can you identify and prevent bias from creeping into your risk assessment practices?
• How does one address IQ evidence expectations for SaaS and Cloud Part 11/Annex 11 compliance?
Pharmaceutical company medical information data, pharmacovigilance data, and SaaS data in the cloud all share a need for risk based integrity checks. Yet often our risk assessment practices themselves have unseen bias that can influence the integrity of electronic information. Come listen, question, and share your own electronic information integrity experiences either as a challenge or a success.
Learning Objective : Evaluate the need for validation of systems not currently identified by authorities; Assess and remediate bias in their risk analysis practices; Apply negotiating points for IQ evidence with SaaS and cloud suppliers.
Speaker(s)
Medical Information Database: To Validate or Not to Validate - That Is The Question
Andrew Harbrow, MPharm, RPh
PrimeVigilance, United Kingdom
Head of Medical Information Operations
The Missing Link in Validation Today: IQ Evidence from SaaS and Cloud Providers
Teri Stokes, PhD, MS, MT
GXP International, United States
Director, Quality Assurance Compliance
The Risk of Risk Assessment
Breffni Kennedy Martin
Regintel Ltd, Ireland
Managing Director