Category: Blog
20 Oct, 2020
The value in archiving eTMF’s beyond compliance requirements
All pharmaceutical companies are required to keep key GxP records (eTMF data, clinical study reports, lab notes etc) for the long term. EMA guidelines which came into…
07 Oct, 2020
The value of digital preservation
Digital preservation, so much more than a backup It is a common misconception (and one we hear a lot) that digital preservation is simply a backup of…
18 Aug, 2020
The ALCOA+ principles in practice – Part 3
In the third and final part of our blog series exploring the ALCOA+ principles, we’re focusing on ‘+’; Completeness, Consistency, Enduring and Availability. You can read Part…
04 Aug, 2020
Planning for data management success
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
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
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…
