CryoShipper Qualifier - Data Log

Job type:
on-site
Start:
n.a
Duration:
n.a
From:
Synectics
Place:
Massachusetts
Date:
05/27/2014
Country:
flag_no USA
project ID:
712428

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The CryoShipper data logger measures time and temperature data for the CryoShipper XC and SC4/2V. The device uses a USB interface for transfer of pdf reports. A protocol is required to be generated and approved within the documentation system.

Qualification of this device is to include the following items in addition to standard protocol boilerplate.
1. Simulate a controlled temperature profile with device
2. Download report and verify that time and temperature values are correct as well as additional report elements.
3. Other visual displays on device

No part 11 testing is required for this device. The deliverable for this part of the project is an approved summary report in the site documentation system. Another deliverable is to draft revisions or new Cell Bank Suite SOPs to enable the use of the loggers.

SKILLS:
CryoShipper XC and SC4/2V experience