Change controls
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
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 Life Science business processes across the board – for example, as a trigger for activities in:
Change Controls are one of the most useful tools for control in Life Science business processes across the board – for example, as a trigger for activities in:
- Creating a new Submission
- Updating RIM information
- Updating Promotional Materials
- Control of production processes and batches
- Changes in manufacturing information
- Implementation of corporate or site-specific processes
- Creating a new Submission
- Updating RIM information
- Updating Promotional Materials
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 not get modified without an approved Change Control
Approval of associated controlled items closes the Change Control
