Data Integrity - Why is this a Hot Topic Now? by: Theresa A. McCarthy, Audit Inspection Readiness and Compliance Effectiveness Manager
Recently published regulatory guidance documents have been published, the FDA has issued multiple warning letters and a firm was recently cited for not having a plan in place to ensure quality management processes are in compliance with data integrity requirements.
Have you has this discussion with your Product Inspectors, Process Owners, Internal Audit Team, Governance Bodies and Management Review Teams? Theresa will present a summary of the challenges being noted by agencies.