Ensuring GxP Compliance with Monitoring System Transparency

How viewLinc Cloud Manages Updates

In life science environments, ensuring regulatory compliance is paramount. This is particularly true for industries governed by Good Practice (GxP) guidelines, where even the slightest software update to a validated or qualified system can introduce risk. 

With the Vaisala viewLinc Cloud Continuous Monitoring System, our GxP-compliant customers depend on reliable, validated software with a secure audit trail to protect data integrity. Creating a monitoring system that meets these needs requires a meticulous approach to software development. In viewLinc Cloud, we have added the functions that help with managing updates while ensuring the software remains in a validated state. 

Continuous Validation

Drawing on our long history of developing software for GxP applications, we’ve designed viewLinc Cloud to meet the needs of users governed by regulations such as FDA 21 CFR Part 11 and EU GMP Annex 11.  Following our established Quality Management System and utilizing a robust Software Development Life Cycle, viewLinc Cloud has been designed to ensure Computerized Software Assurance (CSA) not only at time of release, but for the life of the system. Using automated regression testing, the software continuously verifies that core GxP functions are operating as designed. 

Rigorous testing 

During the development cycle of viewLinc Cloud, we subject our software to thousands of tests designed to verify performance of key functions. This includes tests focuses on the GxP-compliant aspects of viewLinc, ensuring these crucial functions meet the stringent standards required by our customers.

Automated Testing 

In viewLinc Cloud, these GxP-related tests are not just a one-time affair; automated tests guarantee that the critical functions required for compliance are operating flawlessly.

Scheduled releases

Unlike most cloud applications that update in the background, potentially introducing unforeseen changes, we take a different approach with viewLinc Cloud. Recognizing the risk associated with unannounced updates for our GxP customers, we pre-schedule releases of software updates. 

A month prior to the scheduled release, we provide our customers with access to an instance of the new release hosted on Amazon Web Services. This allows them to review the upcoming changes and assess their impact on their operations.

To aid our customers in their evaluation process, we provide comprehensive documentation accompanying each release. This includes a detailed change log outlining the modifications and a risk assessment to help focus their attention on GxP-Relevant functions that could impact product quality.

Transparent Communication

Within the viewLinc user interface, we have implemented an icon to notify users of impending updates. Clicking this icon takes you to viewLinc Cloud’s Update Center, a new addition to the interface. This section serves as a repository of information related to updates, including embedded help topics accessible through a sliding tab.

In conclusion, managing updates in a GxP-compliant environment requires more than just technical prowess; it demands a commitment to transparency, communication, and meticulous planning to integrate compliance with continuous improvement. At Vaisala, we recognize the unique challenges faced by our GxP customers, and our approach to managing updates reflects our unwavering dedication to their compliance and operational integrity.

viewLinc Cloud Features 

• Web portal access from anywhere: Monitoring, Alarming, Reporting, Audit Trail, GxP-compliant
• Reduce IT footprint & Improve IT performance
  • viewLinc Cloud gives you access to the full resources of the world's most broadly adopted cloud platform
• Subscription-based cloud monitoring system
  • A tiered subscription model with customizable feature sets giving viewLinc Cloud users more control over the features they need
• Ensure Business Continuity with infinitely scalable server performance and system availability
• Data Integrity & Security
• Lower startup & predictable maintenance costs
• Simplified system implementation & system growth
• Continuous validation
• Available in eleven languages