CAPA & Events software that drives continuous improvement

Qualio’s Events makes CAPA and nonconformance management stress free. From detection to verification of effectiveness, we help you be proactive and audit ready.

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Challenge

To operate effectively and compliantly, teams need to establish and record procedures that define the processes surrounding CAPAs. 

Among many things, auditors will look for consistency across CAPA procedures as well as verification of effectiveness. Consistency and well-documented procedures can be difficult with a paper-based or siloed QMS system. 

Solution

Qualio’s cloud-based QMS helps you easily manage all aspects of Events from root cause to verification of effectiveness.

You have an efficient and automated path from complaint to resolution. Within Events, you can use templates and workflows that make CAPA management easy and audit ready. 

Easily define CAPA stages, assign tasks and training, ensure all documents are updated, and have a procedure ready to present to an auditor. 

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Save time with automated workflows and templates

  • Efficiently create a compliant CAPA workflow process with custom stages for Non Conformances, Deviations, Incidents / Near misses, and Complaints 
  • Automate tasks and reminders to teammates involved in quality event processes. 
  • Ensure supplier relationships stay intact with an organized process for SCARs.

Visibility across the entire organization

  • Flexible reporting so you can easily keep management up to date on incident rates, open CAPAs and VoEs and more. 
  • Enjoy a single source quality system where everything is connected from design controls to training to audit reports. 
  • Update a product's risk management file and DHF easily referencing an associated CAPA.
  • Connect your team’s support systems like Netsuite and Zendesk to Qualio via API, making complaint escalation seamless

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Easily determine root cause and become proactive

  • Determine root cause with a fully-connected system and full visibility into the entire product lifecycle. 
  • Simply create new documents and forms from CAPAs to ensure glitches don’t repeat. 
  • Avoid bottlenecks with an automated routing and escalation process to expedite issue resolution.

Have quality and regulatory experts on your side

  • Save time and resources by utilizing our expert quality team.
  • Get up and running quickly and through validation in record time.
  • End-to-end concierge service from SOPs, gap assessments, to internal/supplier audits and more.

Learn more about Qualio Plus >>

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Don’t take just our word for it.

Passed our MDSAP Recertification Audit! All QMS processes are captured within Qualio ... as well as Events (CAPA, NCR, PMS, ECN).

John P
Research And Development Manager

[5 stars for] CAPA Reports and resolving quality issues.

Fabre R
Operations supervisor

We use the software for class I exempt medical products. We built the Quality System from the ground and this software allows us to track the product at each stage. The software helped us in training the employees. It also helped in controlling complaints, Non-conformance, and CAPA.

Abhishek S
Quality Assurance Manager & RA

My favorite thing is how Qualio keeps us in a constant state of audit readiness. We chose Qualio as we needed our system to be scalable to support our rapid growth and facilitate quick employee onboarding.

Deb Glancy
Director of Quality

See other features that make Qualio the #1 Top Rated Cloud QMS.

Document Management

Training Management

Design Control

Risk Management

Change Control

Audit Management

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