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Change Requests

Change Requests

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Having a Change Request mechanism that is seamlessly connected to every part of the CARA Life Science Platform (Quality, Regulatory, Safety and Clinical) is a true differentiator and brings large business value to you, with a true enterprise view of your business activities

Change Requests are one of the most useful tools for control in the Life Science business processes across the board - for example, as a trigger for activities in:

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Creating a new submission

Updating RIM information

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See how Change Requests can be linked with Regulatory documents and processes.

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Updating Promotional Materials

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Control of production processes and batches

Changes in manufacturing information

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Manufacturing information is itself linked to our RIM module

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Implementation of corporate or site-specific processes

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Study Protocol amendments

Study site management changes tracked in eTMF

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Explore eTMF and CTMS on the CARA Life Sciences Platform

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Patient or investigator process changes tracked in our CTMS

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System replacements

Changes to system SOPs

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Check out SOP management in Quality Documents, as well as our seamlessly connected LMS

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Training including our LMS

Change Requests in CARA can be linked to any other document or data item in the system, and have its own data, priorities, lifecycle and workflow.

 

This ensures that 

  • Controlled items do note get modified without an approved Change Request

  • Approval of associated controlled items closes the Change Request