data integrity Archives - Arkivum

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29 Apr, 2021

Webinar: Navigating GCP Data Compliance Requirements with Russell Joyce

Whitney Armstrong

Thursday 20th May 2021, 2pm BST The preservation of digital source data and associated study documents is a critical component of compliance with Good Clinical Practice and…

29 Mar, 2021

Should you build or buy your eTMF archival solution?

Whitney Armstrong

The build vs buy conundrum for businesses is not new when it comes to decisions around implementing new software. For drug sponsors, regulatory requirements to manage the…

09 Dec, 2020

Long-term digital archives: an accessible and accurate audit trail

Matthew Cooke

Long-term digital archives for an accessible and accurate audit trail Every pharmaceutical and biotech company needs to have a robust approach and process for records management, long…

26 Jun, 2020

Webinar: Data accessibility; do you need to be able to access everything?

Simon Bostock

As more and more born-digital content is created, data accessibility is only going to grow in importance. But how many organisations truly consider the implications and complexities…

21 May, 2020

The ALCOA+ principles in practice – Part 1

Tom Lynam

ALCOA+ is a set of principles for ensuring data integrity. Introduced in the 90s by the US Food and Drug Administration (FDA), the ALCOA acronym was developed…

25 Feb, 2020

What does the future hold for data management in the pharmaceutical sector?

George Waidell

What does the future hold for data management in the pharmaceutical sector? In Roman mythology, Janus was the god of beginnings, transitions, duality, and endings – he…