regulatory compliance Archives - Arkivum

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23 Mar, 2023

The data retention requirements of MDR 745

Tom Lynam

Arkivum recently hosted a webinar with Stuart McCully, on the impact of the new medical device regulation (EU regulation 2017/745 or often simply referred to as MDR...
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09 Mar, 2023

Webinar: Protecting data for long-term use: An Insight into Arkivum’s Digital Archiving and Preservation Solution

Annabel Allum

Join Arkivum’s Customer Delivery Manager, Antonia Witten, on the 28th March @2pm (GMT) for our webinar exploring our innovative digital archiving and preservation software solution.   During this...
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02 Mar, 2023

eBook: How to prepare your data for a clinical trial site inspection

Annabel Allum

The prospect of regulatory inspection is often sufficient to send adrenaline pulsing through the veins of anyone involved in clinical research. Poor inspection outcomes can lead to...
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16 Feb, 2023

4 reasons why your eTMF solution is not a viable digital archive

Caitlin Morris

Using an eTMF solution is an effective way to manage data during a clinical trial. But upon completion, using the solution as a means of archiving the...
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07 Feb, 2023

Inspection Time: Results of the GCP IWG 2021 and how to improve your results for 2023

Caitlin Morris

Introduction  The results are in from the Annual Report of the Good Clinical Practice (GCP) Inspectors Working Group (IWG) 2021. For those who are unaware, the GCP...
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26 Jan, 2023

Webinar Recording: The Impact of the New Medical Device Regulation on Records Managers

Caitlin Morris

The new Medical Devices Regulation (MDR) requires medical device manufacturers to maintain specified records for a minimum of 10 years (non-implantable devices) after the clinical investigation (trial)...
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