regulatory Archives - Arkivum

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08 Jun, 2021

Renewed certifications in ISO 9001 and ISO 27001

Whitney Armstrong

We are delighted to announce that we have successfully renewed our certificates in ISO 9001:2015 for quality management and in ISO 27001:2017 for our information security management…

08 Jun, 2021

What you need to know about the new Medical Device Regulation (MDR)

Harriet Clark

As of 26 May 2021, the 2017/745 MDR¬†officially superseded the 93/42/EC Medical Device Directive (MDD) that came into effect in 1993 and is now a European Union…

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…

18 May, 2021

Webinar: Practical Approaches to Digital Preservation for Life Sciences with Russell Joyce and Matthew Addis

Whitney Armstrong

Thursday 24th June 2021, 2pm BST Presented by Russell Joyce and Matthew Addis, this educational webinar examines practical approaches for the successful archiving and preservation of clinical…

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…

03 Feb, 2021

Infographic: TMF Futures, Keeping Data Alive

Whitney Armstrong

Arkivum is delighted to publish an infographic highlighting the major trends impacting the long-term management of clinical trial data for life sciences organisations. Arkivum’s inaugural TMF survey,…