Enhancing Visibility and Accountability in QMS with qmsWrapper’s New Log Functionality

Capturing Small Yet Crucial Events in QMS

In the fast-paced environment of medical device development, minor changes or updates often slip through the cracks. Whether it's a small tweak in documentation, an update to a feature, or a modification in labeling, these changes, though seemingly minor, can have significant implications. Traditionally, these small but crucial events are often forgotten or poorly documented, leading to gaps in the QMS. This can result in non-compliance with the stringent requirements of MDR and ISO 13485:2016, risking the quality and safety of the product.

 

The Solution: qmsWrapper’s Log Functionality

qmsWrapper introduces a streamlined way to ensure every event, no matter how small, is captured and logged. This new functionality transforms the traditional use of forms into a dynamic log system that enhances visibility, accountability, and traceability within the QMS.

 

 

How It Works?

 

1. Immediate Capture of Events:

Suppose a team member identifies a small but necessary feature change that wasn’t part of the original design. In the past, this might have been an afterthought, easily overlooked in the rush to meet deadlines. With qmsWrapper, the user can immediately capture this event by selecting the appropriate form—say, a Software Change Form—from the Quickly Access menu.

   

2. Automatic Logging and Visibility:

Once the form is filled out, qmsWrapper automatically logs this entry. The event is no longer just a note or a forgotten task; it is now a documented QMS event visible to the entire team. This log is accessible to all users, making it easy to track and follow up on the event.

 

3. Facilitating Follow-Up Actions:

The logged event can now trigger further actions. Whether it’s a review, an approval process, a risk assessment, or the assignment of a task, the event is part of an accessible log that ensures nothing falls through the cracks.

 

4. Transforming Data into Actionable Insights:

The new log functionality doesn’t just capture data—it organizes it into a format that is easy to view, understand, and act upon. The forms are not just static entries; they become part of a dynamic log that QMS administrators can use to monitor ongoing activities, generate reports, and ensure compliance.

 

5. Empowering All Users to Contribute:

With this system, every team member becomes an active contributor to the QMS. By simply filling out a form, they create a log entry that initiates the QMS process. This democratization of the QMS process ensures that all relevant events are captured and that the responsibility for maintaining the QMS is shared across the team.

 

 

The Impact:

This new functionality is not just a minor enhancement—it’s a game-changer in how QMS events are captured, logged, and managed. It ensures that no event is too small to be documented, providing a comprehensive log that QMS administrators can rely on to maintain compliance and quality. The potential of this system is vast, limited only by the creativity and diligence of the forms you create and the events you log.

 

Conclusion:

qmsWrapper’s new log functionality transforms the way QMS is managed, turning everyday forms into powerful tools for maintaining compliance and quality. By ensuring that every event is captured and logged, qmsWrapper empowers users and administrators alike to stay on top of their QMS, making compliance with MDR and ISO 13485:2016 not just achievable but streamlined and efficient.