Having a Change Control 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 Controls 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:
Creating a new submission
Updating RIM information
See how Change Requests can be linked with Regulatory documents and processes.
Updating Promotional Materials
Control of production processes and batches
Changes in manufacturing information
Implementation of corporate or site-specific processes
Changes to system SOPs
Check out SOP management in Quality Documents, as well as our seamlessly connected LMS
Training including our LMS
Change Controls 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 Control
Approval of associated controlled items closes the Change Control