Key topics
An introduction to the masterclass and what will be covered in the mini-lessons.
From a regulatory perspective, know who is responsible and what knowledge they must have about specialized computer systems.
Learn who is ultimately responsible for the validation of the computerised systems used in clinical trials.
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.
Learn how Viedoc ensures regulatory compliance and strategically meets requirements in its testing process.
Understand what the eCF requirements are and how they have been formatted.
Learn about the contents of the Viedoc Inspection Readiness Packet and their classification.
The Viedoc standard SLA delivers on regulatory expectations.
The Viedoc data processing agreement describes how we undertake to only process personal data in accordance with documented instructions from the customer.
How to audit Viedoc and what documentation is available.
"Viedoc is an easy-to-use platform made even better with great customer service"