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20 May, 2021

The difference between data backup and data archiving, and why it matters to you

Chris Sigley

Data is your organisation’s most valuable asset – it’s paramount that you protect it. If you are faced with large amounts of precious data which you will…

19 May, 2021

Reviewing quality and completeness for Study Lock and Archival

Whitney Armstrong

The European Medicines Agency (EMA) Guidelines on the content, management, and archiving of the clinical Trial Master File (paper and/or electronic), were finalised at the end of…

27 Apr, 2021

FAIR data principles, what are they and how can they support compliance?

Harriet Clark

Life Sciences organisations are becoming big data enterprises, generating large amounts of data from clinical studies, lab equipment and drug development. However, this plethora of data is…

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…

03 Mar, 2021

When is the right time to archive your eTMF?

Whitney Armstrong

The archival of eTMFs has been the focus of much discussion since regulators began to increase their focus on the topic. Both the US Food and Drug…

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…