Clearlane CAPA

Clearlane CAPA

Clearlane Apps
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About

Clearlane CAPA is a Jira Cloud app for quality and regulatory teams managing corrective and preventive actions in medical device, pharmaceutical and ISO 9001 manufacturing environments. Existing Jira work items—including complaints, nonconformities, deviations and audit findings—can become CAPAs without new issue types, workflows or fields. The guided process covers containment, Five Whys root-cause analysis, a signed action plan, linked Jira actions and a dated effectiveness check; an ineffective check returns to root-cause analysis. Teams can review similar CAPAs, search CAPA data with JQL, export CSV and generate a PDF evidence file with workflow history, actions, signatures and audit trail. CAPAs can also start from Jira Service Management requests. A read-only Rovo agent answers questions about CAPA records. Built on Atlassian Forge, the app keeps its records in the customer’s Atlassian site.

About

SimplerQMS is an electronic quality management system (eQMS) built by life science experts. It helps life science companies stay compliant with FDA, ISO, and GxP requirements while reducing manual work and improving audit readiness. With SimplerQMS, teams can easily manage documents, change control, training, CAPA, analytics, and more on one cloud-based platform. The system is fully validated, so companies can start quickly without a long validation process. What customers appreciate most: • Compliant processes and fewer manual errors • Fast implementation and smooth data migration • User training and 24/7 global support • Guidance from compliance experts throughout the journey Whether you're a growing startup or an established life science company, SimplerQMS gives you the tools and support to build a strong quality culture and stay audit-ready every day.

Platforms Supported

Windows Not Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Not Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported

Platforms Supported

Windows Supported
Mac Supported
Linux Not Supported
Cloud Supported
On-Premises Not Supported
iPhone Supported
iPad Supported
Android Supported
Chromebook Not Supported

Audience

Quality, regulatory and CAPA owners at medical device, pharma and ISO 9001 manufacturers using Jira Cloud.

Audience

Startups and Growing Life Science Companies – Medical Devices, Pharmaceutical, Biotech, Laboratories, CRO / CMO

Support

Phone Support Not Supported
24/7 Live Support Not Supported
Online Supported

Support

Phone Support Supported
24/7 Live Support Supported
Online Supported

API

Offers API Not Supported

API

Offers API Supported

Screenshots and Videos

Screenshots and Videos

Pricing

$10/month
Plans start at $10/month for up to 10 users. Larger teams pay per user, billed monthly or yearly through Atlassian Marketplace. A free trial is available with every plan. There is no setup fee.
Free Version Not Supported
Free Trial Supported

Pricing

$17,500 / year
We offer subscription-based pricing with everything you need – integrated QMS modules, full implementation and onboarding, validation, user training, cloud hosting, QMS templates, data migration, and ongoing support. No hidden costs.
Free Version Not Supported
Free Trial Supported

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

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Reviews/Ratings

Overall 3.0 / 5
ease 3.0 / 5
features 2.5 / 5
design 2.5 / 5
support 3.5 / 5

Pros & Cons from Real Users

Pros

  • The SimplerQMS team have made the transition from a paper based system stress-free and have provided excellent support for my team.
  • The technical staff were the best part of our experience. During onboarding they made a real effort to explain how the system works and to help whenever we had questions, and they were responsive and patient throughout. The platform is built on Microsoft Azure and Microsoft 365, so documents live in a familiar SharePoint/Office environment rather than in a completely proprietary system.

Cons

  • Some of the existing work flows don't work with our particular processes and we have had to find work arounds.
  • In our experience the system is extremely inconvenient, cumbersome and inflexible. Everyday document work requires far more clicks and steps than it should, the interface is heavy, and adapting the workflows to how our company actually operates proved impractical. After evaluating it we decided not to implement it at all. The far bigger problem is the commercial side. Read the termination and renewal provisions extremely carefully before signing. Based on our experience you cannot simply stop using the service during the contract year and stop paying. Notice must be given at least 90 days before the renewal date; miss that deadline and you may be invoiced for another full contractual period even though you no longer use the system. Termination must be submitted in writing and its receipt expressly confirmed. We told the company twice by telephone that we wanted to discontinue the service, and those conversations were not treated as formal notice. Do not rely on phone calls: send written notice, request written confirmation, and keep all correspondence.

Training

Documentation Supported
Webinars Not Supported
Live Online Not Supported
In Person Not Supported

Training

Documentation Supported
Webinars Not Supported
Live Online Supported
In Person Not Supported

Company Information

Clearlane Apps
Founded: 2026
France
clearlaneapps.com/capa/

Company Information

SimplerQMS
Founded: 2017
Denmark
www.simplerqms.com

Alternatives

CAPA Manager

CAPA Manager

Adaptive Business Management Systems

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QT9 QMS

QT9 QMS

QT9 Software
SBS Quality Management Software

SBS Quality Management Software

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Dot Compliance QMS

Dot Compliance QMS

QMS for Life Sciences

Categories

CAPA Supported

Categories

Audit Supported
CAPA Supported
Compliance Supported
Document Control Supported
ISO Compliance Supported
Quality Management Supported

CAPA Features

Audit Management Supported
CAPA Planning Supported
Change Management Supported
Complaint Management Supported
Incident Management Supported
Nonconformance Tracking Supported
Quality Control Supported
Risk Management Supported
Root Cause Analysis Not Supported
Training Management Supported

Audit Features

Alerts / Notifications Supported
Audit Planning Supported
Compliance Management Supported
Dashboard Supported
Exceptions Management Not Supported
Forms Management Supported
Issue Management Supported
Mobile Access Supported
Multi-Year Planning Not Supported
Risk Assessment Supported
Workflow Management Supported

Compliance Features

Archiving & Retention Supported
Artificial Intelligence (AI) Not Supported
Audit Management Supported
Compliance Tracking Not Supported
Controls Testing Not Supported
Environmental Compliance Not Supported
FDA Compliance Supported
HIPAA Compliance Supported
Incident Management Not Supported
ISO Compliance Supported
OSHA Compliance Not Supported
Risk Management Supported
Sarbanes-Oxley Compliance Not Supported
Surveys & Feedback Not Supported
Version Control Supported
Workflow / Process Automation Supported

Document Control Features

Archiving & Retention Supported
Automated Routing Supported
Change Management Supported
Compliance Management Supported
Electronic Signature Supported
Escalation Management Supported
Periodic Review Supported
Version Control Supported

Quality Management Features

Audit Management Supported
Complaint Management Supported
Compliance Management Supported
Corrective and Preventive Actions (CAPA) Supported
Defect Tracking Supported
Document Control Supported
Equipment Management Supported
ISO Standards Management Supported
Maintenance Management Supported
Risk Management Supported
Supplier Quality Control Supported
Training Management Supported

Integrations

Atlassian Rovo Supported
Jira Supported
Jira Service Management Supported
Microsoft 365 Not Supported
Microsoft Entra ID Not Supported

Integrations

Atlassian Rovo Not Supported
Jira Not Supported
Jira Service Management Not Supported
Microsoft 365 Supported
Microsoft Entra ID Supported
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