Tag: regulatory compliance
23 Mar, 2023
The data retention requirements of MDR 745
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
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
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
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
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
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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