Quality issues don’t always arrive neatly classified.
Sometimes, an employee simply notices something that doesn’t look right. From there, the issue may require assessment, investigation, corrective action, and follow-up to make sure it doesn’t happen again.
SimplerQMS connects this entire quality event lifecycle in one system – from the first report to resolution and continuous improvement.
With Quality Events & CAPA, life science teams can bring observations, investigations, corrective actions, and related quality records together in one connected workflow.
What’s New: A More Connected Quality Process
Quality Events & CAPA introduces a more structured way to capture, manage, and follow up on quality issues, while keeping the relevant records, actions, and decisions connected throughout the process.
Whether you’re managing an employee-reported concern, an audit finding, a customer complaint, a deviation, or an issue that requires CAPA, teams can keep the relevant information, actions, and decisions connected in one system.
Here’s how it works.
Create a Quality Culture Where Everyone Can Report Issues
Observations give everyone in your organization a simple way to report what they see, without needing to determine whether something is a deviation, non-conformance, or another type of quality event.
QA can then review each submission and determine the appropriate next step.
Why it matters
- Lower the barrier to reporting. Employees can report potential issues without needing quality-specific terminology.
- Catch issues earlier. Give teams a simple way to surface concerns before they become larger problems.
- Keep QA in control. QA assesses each Observation and decides whether to close it or escalate it.
- Maintain traceability. Escalated Observations remain linked to the resulting Quality Event.
- Bring everyone into quality. Extend quality awareness beyond the QA team.
Manage Quality Events from Capture to Closure
When an issue requires further investigation and correction, it can move into a structured Quality Event workflow – keeping the investigation, decisions, actions, and supporting information connected.
Manage different types of Quality Events in one system, including: Audit, Complaint, Deviation, Non-conformance, Supplier, and Customized Events. You can rename customized event types to match your industry, terminology, and company setup.
What teams can do
- Create and manage different quality event types
- Capture and assess observations, then investigate and evaluate quality events
- Evaluate impact, severity, scope, and required actions
- Assign and track actions and responsibilities
- Determine whether a quality event requires reporting to an authority
- Escalate quality events to CAPAs and create and manage CAPAs when needed
- Verify CAPA effectiveness and maintain end-to-end traceability across quality events, CAPAs, change requests, documents, and related actions
- Use connected quality information to maintain visibility and identify trends
Configurable workflows help organizations align Quality Events with their own processes, roles, and decision points, while maintaining consistency and control.
The result: less time spent searching for information and recreating records, and more visibility into what happened, what needs to happen next, and who owns it.
Drive Continuous Improvement with CAPA
Not every Quality Event requires a CAPA. But when an investigation identifies a recurring or systemic issue, CAPA provides a structured path to address the underlying cause.
With CAPA Management, teams can:
- Create CAPAs from Quality Events and other quality processes
- Configure CAPA Types to support different workflows and requirements
- Investigate root causes
- Define and assign corrective and preventive actions
- Track owners, due dates, and implementation
- Conduct effectiveness checks
- Link CAPAs to source events, documents, change requests, and related records
- Take further action when effectiveness requirements are not met
This connects resolution with improvement, helping teams address not just the issue itself, but the causes behind it.
One Connected Quality Event Lifecycle
Together, Observations, Quality Events, and CAPA support a connected journey:
CAPTURE → ASSESS → INVESTIGATE → RESOLVE → IMPROVE
Here’s what that looks like in practice:
Not every Observation becomes a Quality Event, and not every Quality Event requires a CAPA. The connected workflow gives teams the flexibility to apply the right level of process while maintaining traceability throughout.
From Quality Events to Lasting Improvement
SimplerQMS brings the full quality event lifecycle together — giving employees a simpler way to report issues, giving QA greater control and visibility, and giving organizations a structured path from first capture to lasting improvement.
Want the details? For the full list of updates and enhancements, check out the release notes article here.
Ready to see it in action? Book a Demo today.
Existing customer? Contact SimplerQMS CS Team to learn more about Quality Events & CAPA and discuss how it can fit into your quality processes.
