PRIVATE cloud benefits

CLIN-LINK is your solution for storing sensitive data and documents and sharing with selected external partners. CLIN-LINK will be installed on your own PRIVAT Cloud server - therefore no data leak - not even metadata. CLIN-LINK is validated and compliant to GCP and GDPR. Because you receive your own PRIVATE cloud, you can also decide many options yourself. From level of access control (two-factor, IP whitelist) to design colour (green, blue, yellow or other company colour). You also decide when you want updates. So it does not interfere with a just ongoing important activity with a partner. CLIN-LINK is adapted to your needs and wishes. #gcp #cloud

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FDA will require clear knowledge of Cloud server location

From a still draft industry guidline on “Use of Electronic Records and Electronic Signatures in Clinical Investigations Under “21 CFR Part 11 –Questions and Answers Guidance for Industry” -June 2017

Due to CLIN-LINK setup on a PRIVAT cloud, you will meet this requirement.

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Source: https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm563785.pdf