App Version 2.0 introduces Observations, a simple way for any employee to report potential quality issues, with QA reviewing every submission and deciding what happens next. It also brings new capabilities to Quality Events & CAPA, based on feedback from customers like you. From the first report, teams can move through investigation and CAPA without switching systems.
Launch Schedule
App Version 2.0 will first be released to the training environments of all SimplerQMS customers starting from September 3, 2026. Quality Events & CAPA will be available in your training environment to support implementation and training.
App Version 2.0 will be released to all production environments from September 24, 2026. You may see the Version 2.0 update reflected in your production environment at this time, while access to the Quality Events & CAPA functionality will be managed according to your implementation readiness.
Validation Reports
Validation Reports for this release will be available on the same day as the release.
New Features
Observations
Observations in SimplerQMS help turn every employee into a quality sensor, not just QA. Employees across your organization can report potential quality issues as Observations without needing to determine whether the issue is a deviation, non-conformance, complaint, or another event type. QA reviews each Observation and decides whether to close it or escalate it into a Quality Event.
How this supports your work
Simple reporting. Any employee can report what they see as an Observation without needing to determine its final classification. Users with Full, Standard, or Light licenses can create and access Observations.
Controlled QA assessment. QA reviews each Observation and decides whether to close it or escalate it into the appropriate Quality Event.
Traceability. Escalated Observations remain linked to the resulting Quality Event.
Streamlined workflows. Manage Observations, Quality Events, and CAPA in one integrated eQMS.
Quality Events & CAPA
When quality information is spread across disconnected tools, teams spend valuable time searching for records, connecting information, and preparing evidence. SimplerQMS Quality Events & CAPA help life science teams capture, investigate, record, and improve — now with Observations providing an easier way to start.
Here’s what you can do
Manage different Quality Event types through structured workflows
Assign roles and responsibilities across investigations and follow-up
Link Quality Events with CAPA and related quality records
Track investigations, actions, approvals, and closure
Use connected quality information to identify trends
How this supports your work
Traceability. Keep event records, investigations, evidence, and follow-up actions connected.
Less duplicate work. Manage related quality records in one system instead of recreating information across tools.
Better visibility. Track open events, assigned actions, and progress through the workflow.
Continuous improvement. Use quality event information to identify recurring issues and areas for improvement.
How We'll Support Your Rollout
You don't need to navigate the transition alone. No action is required at this stage. Our Customer Success team will contact you to coordinate Quality Events & CAPA implementation, training, and production rollout.
What to expect:
Implementation and workshop planning. Your Customer Success team will share the implementation plan and workshop schedule, based on your organization’s priorities and readiness.
Training plans. Your Customer Success team will share the training plan to help your team learn the workflows. Instructor-led training can also be arranged where applicable.
Production rollout. Quality Events & CAPA will be available in your SimplerQMS production environment from September 24, 2026. You can plan your implementation and training according to your own timeline, with support from SimplerQMS Customer Success team throughout the rollout.
Ongoing support. The team will remain available to help your team adopt the workflows and address questions as you begin using Quality Events & CAPA in daily operations.
You can also access our micro-training materials to learn how Quality Events & CAPA support compliance and continuous improvement, and how to manage them in SimplerQMS.
What's Next from SimplerQMS?
At SimplerQMS, we continuously improve the platform to support evolving life science requirements and customer feedback.
In the coming weeks, we’ll continue delivering:
Improvements that support more efficient and reliable quality workflows
Enhancements designed to improve usability and document consistency
New capabilities aligned with regulated quality processes
Stay tuned for more product updates from the SimplerQMS team.
We'd Love to Hear from You!
If you have questions or would like to share feedback about these improvements, our team is here to help.
EU: +45 93 90 16 14 | US: +1 888 830 9807
Customer Support: [email protected]
Help Center: SimplerQMS Knowledge Base
LinkedIn: SimplerQMS