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04 Aug, 2020

Planning for data management success

Tom Lynam

I recently spoke on an Arkivum webinar about how to build a plan for successful long-term data management. During the session I covered a range of general…

07 Jul, 2020

The ALCOA+ principles in practice – Part 2

Tom Lynam

The pharmaceutical industry is data-driven – risks are carefully calculated and managed using data, key strategic and management decisions heavily rely on data.  The importance of data…

16 Jun, 2020

Pharmaceutical electronic archiving; Learning to swim with self-assessment and maturity models

Matthew Addis

Pharmaceutical and related organisations that need to retain digital content for compliance often have strict regulatory requirements that they need to follow.  For example, the FDA, MHRA…

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…

07 May, 2020

Preserving corporate memory through digital archiving

Sam Roberts

Take a minute to consider all of the digital assets your business has. Start with the website. As well as the design, copy and logos that make…

08 Apr, 2020

eTMF archiving myths, misconceptions, and half-truths – here’s what you need to know

George Waidell

All pharmaceutical companies have a regulatory requirement to keep eTMF data for the long term – last year’s European Medicines Agency’s (EMA) guidance stipulating storage for over…