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Bulk/Non-Uniquely Number Kits in a Study
If the Kits in a study are not identified with a unique number (Kit Number), then the study is intended to make use of the advantages of Bulk/Non Uniquely Numbered Kits.
This concept of Kits ca…
Clinical Trial Supplies Accountability
To account all the Supplies of Clinical Trial is a Regulatory requirement. Traditionally people used to use paper based or Excel based tracking of the Supplies. This is tedious, time consuming and…
Digitize Instructions for Use (IFU) to Comply with EU MDR
The regulation brings digital enablement to the forefront, compelling electronic instructions for use.
EU MDR is turning digitization on its head. This new regulation, which goes into effect Ma…
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- Clinical Automation (8)
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- Labeling (14)
- Regulations (14)
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- Writing (8)