Meridian Cloud for Life Sciences can facilitate compliance with Title 21 CFR, cGMP, GMP Annex 11 and other key regulations with features for electronic signatures, audit logs, controlled document editing, and automated watermarks and print stamps.
Our product release process follows an validated environment compliance change management process with daily non-functional and regular functional updates. Our releases follow a time-gap release process between Test tenancies and Production tenancies to allow change management procedures to be executed between functional upgrades. This allows customers to stay both up-to-date from a software perspective and compliant from a validation perspective.
Features exclusive to Meridian Cloud for Life Sciences:
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Electronic Signature — the ability to verify the user identity as part of a review or approval workflow operation
You must enable the Signature watermark type for each document type where you want to use e-signatures.
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Test reports — Ability to download the daily executed reports of the automated testing executed on the Meridian Cloud for Life Sciences Solution
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Workflow Lockdown — The ability to prevent uncontrolled modification to approved and released documents outside of a controlled workflow
See the list of feature toggles for Meridian Cloud for Life Sciences.
Here is a list of useful links that gives further information on these features and other features relevant for validation purposes:
