Tag: GxP compliance
23 Nov, 2022
What is the Investigator Site File?
What is the Investigator Site File? In relation to clinical studies, the terms “Trial Master File” (TMF) and Investigator Site File (ISF) are commonly used and presumed...
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09 Nov, 2022
eTMF retention requirements: complying with EU Regulation 536/2014
eTMF retention requirements: complying with EU Regulation 536/2014 As we approach the one-year anniversary of EU Regulation 536/2014 coming into effect, I thought it would be a...
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07 Nov, 2022
The Arkivum Solution for Archiver
The Arkivum Solution for Archiver After 3 years and €4 million of European Commission funding, the ARCHIVER project concluded in 2022. The objective of this ambitious project...
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07 Nov, 2022
Webinar Recording: Examining the data retention requirements of EU Reg 536/2014
Examining the data retention requirements of EU Reg 536/2014 As we approached the first anniversary of EU regulation 536/2014 coming into effect, Arkivum hosted a webinar breaking...
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01 Nov, 2022
Webinar Recording: ARCHIVER: Sustainable Preservation of Petabyte Scale Scientific Data
This webinar recording is hosted by João Fernandes, the Project Leader for ARCHIVER from CERN and Matthew Addis, CTO of Arkivum discussing and sharing the experience and...
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24 Oct, 2022
Selecting a New SaaS Solution: How to avoid Analysis Paralysis
Selecting a new system is a daunting task. After all, there is so much to think about. You have to take into consideration your use cases: Does...
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