Master the regulatory expectations

Key topics

Included
mini-lessons

Introduction to Regulatory Expectations and Compliance (1:15 min)
An introduction to the masterclass and what will be covered in the mini-lessons.
Responsibilities (1:18 min)
From a regulatory perspective, know who is responsible and what knowledge they must have about specialized computer systems.
Regulatory Expectations EMA (2 min)
Learn who is ultimately responsible for the validation of the computerised systems used in clinical trials.
Regulatory Expectations: FDA and PMDA (1:04 min)
Gain an understanding of the prerequisites for electronic signature and records use in clinical investigations under 21 CFR Part 11, to ensure that all parties are in agreement.
Testing of Viedoc for Regulatory Compliance (1:03 min)
Learn how Viedoc ensures regulatory compliance and strategically meets requirements in its testing process.
eCRF Requirements (1:44 min)
Understand what the eCF requirements are and how they have been formatted.
VIRP: Viedoc Inspection Readiness Packet (3:29 min)
Learn about the contents of the Viedoc Inspection Readiness Packet and their classification.
Service Level Agreement (1 min)
The Viedoc standard SLA delivers on regulatory expectations.
Data Processing Agreement & Information Security (1:18 min)
The Viedoc data processing agreement describes how we undertake to only process personal data in accordance with documented instructions from the customer.
Audits of Viedoc (1 min)
How to audit Viedoc and what documentation is available.