Change Management Options in Qualio

Change management in the life sciences industry can be overwhelming due to the strict regulatory compliance requirements, extensive documentation demands, and the critical need to maintain product quality and patient safety. Qualio provides you with several options to manage changes within your system, ensuring that every update goes through a process of assessment, approval, implementation, and validation.

Below is a high-level overview of all options, with links to more detailed information if you have a preference for a specific change management method.

To help users log all document changes, Qualio provides a built-in Change Control (CC) form within a document's "Change Control" tab. This CC tab is contained within the individual document versions and is populated when you need to make a change to an individual document or create a new draft. This is an efficient way of updating a single document, as the CC form is controlled by a CC template and cannot be reopened or modified when a document is made effective. A CC record is frequently used to document the justification and potential impact of an update to a document. This provides a clear audit trail, enabling you to easily demonstrate to an auditor the rationale for moving from version 1.0 to version 2.0.

Further information on CC records can be found here.

Document Change Requests (DCRs) are an effective way of managing changes to multiple documents at once, distinguishing them from the single-document revision process described above. Documents that need changes are grouped into one bundle, making it much easier to propose, implement, and track them throughout the entire change process. Approval is needed for each individual document within the DCR, as well as for the overall DCR, providing complete oversight and traceability in a single request.

Further information can be found here.

The Events module is an excellent way to manage more complex changes in your QMS. Examples of such changes include updates to manufacturing processes, changes to systems, or product design changes. A Change Request (CR) Event Template provides the basic structure for your CR process, which can be built upon and customized as needed by defining required steps, creating specific forms, and adding drop-down menus for example.

More information on change management using Events can be found here.

Within the Qualio Design Control module, requirements (user needs, design inputs, design outputs and test cases) and risks are reviewed and approved through the Design Change Control (DCC) process. Documents, such as a Traceability Matrices and Change History Logs, are generated upon the creation of a DCC, making sure your Design History File is kept up to date.

For further information on how to navigate Qualio’s Design Control module, click here.