Elsevier

Articles

Pragmatic Validation of EDC Systems in Clinical Trials

https://www.appliedclinicaltrialsonline.com/act_s/edc_systems

Computer System Validation is a key regulatory requirement and one which challenges the understanding and resources of many research organizations. Achieving the validated state means managing an ever-changing environment of servers, operating systems, EDC software, security patches etc, some or all of which may be outside the direct control of the organization. And all this needs considering before you have even started developing your study database.

GCP expects a risk-proportionate approach, but how can this be approached, pragmatically?

During this webcast we’ll explore the scope of EDC system validation and offer practical ways of dealing with change overload and surviving a visit from the inspectors.

Understand the scope of system validation and the challenges this brings

Discover an approach to unpicking the complexity

Have an opportunity to discuss practical solutions


Will Crocombe, Director, RISG Consulting, UK

Oli Cram, Macro General Manager, Elsevier

Thursday, Sept. 17, 2020 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST

	On demand available after airing until Sept. 17, 2021.

Webcasts

Join us as we explore system validation with Will Crocombe from RISG Consulting, and share practical ways to address change overload and survive a visit from the inspectors.

Live: Thursday, Sept. 17, 2020 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST

On demand available after airing until Sept. 17, 2021.

Elsevier

Articles

Pragmatic Validation of EDC Systems in Clinical Trials

Information Systems in Clinical Trials: Pragmatic Validation of EDC Systems