To maintain the validated state of your QMS, you will need to develop change control procedures for making any changing to the software. In addition to internally driven changes, you will need to use this process anytime your software provider releases a new software version or patch for your system.
So what’s the correct way to handle internal changes and software patch releases? You’ll generally need to complete the following steps:
First, assess how the change might impact your processes (risk).
If the changes don’t require you to update the system (which may be the case with certain software releases), you can update your documentation to reflect the new version of the software.
If the changes do require an update to your system, you need to initiate a change request within your change control process.
Document the proposed changes, making updates to the URS, PQ/UAT, Traceability Matrix and Training Materials as needed.
Once the URS and PQ/UAT documents are approved, execute/retest the updated PQ/UAT.
Include the approved documents in the change request and save them per your internal record retention policies.
Approve and Close the Change Request.
It’s important to remember that regulators often closely scrutinize change control systems, viewing them as a representation of how well a company manages its systems overall. Without a robust change control process in place, you’ll likely look disorganized and invite even closer inspection from the FDA. Get it right the first time, however, and your process will help reassure regulators that changes to your QMS won’t impact product quality or safety.
