Clearlane CAPA

Clearlane CAPA

Clearlane Apps
Qualcy QMS

Qualcy QMS

Qualcy Systems
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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

Qualcy Bio-Med QMS Software has been designed for Bio-Medical companies (including Biotech, Pharma and Medical Device) to manage QMS records for ISO13485 and FDA requirements. * Designed for meeting the requirements for 21 CFR Part 820 * Has built in features for E-sign, audit trails and complies with 21 CFR part 11 requirements. This software helps manage the records for Doc. change control, complaints, audits, CAPA, NC Records, Training Records and more.

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 Not 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

Bio-Medical companies (including Biotech, Pharma and Medical Device)

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 Not Supported

Screenshots and Videos

Screenshots and Videos

Pricing

$59/month
$59/month up to 10 users, then per user; billed by the Atlassian Marketplace, monthly or annual; 30-day free trial
Free Version Not Supported
Free Trial Supported

Pricing

$799 per month
Free Version 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

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Reviews/Ratings

Overall 5.0 / 5
ease 5.0 / 5
features 5.0 / 5
design 4.0 / 5
support 5.0 / 5

Pros & Cons from Real Users

Pros

  • Simple and easy to manage the document change controls. Integrated training module automates the training records. The QMS package comes with calibration and asset management module, which is a big plus.

Cons

  • It took us little longer than expected to get started. It has been a good experience so far.

Training

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

Training

Documentation Supported
Webinars Supported
Live Online Supported
In Person Supported

Company Information

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

Company Information

Qualcy Systems
Founded: 2014
United States
www.qualcy.com

Alternatives

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CAPA Manager

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SBS Quality Management Software

Sunday Business Systems
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

Calibration Management Features

Calibration Instructions Supported
Calibration Schedules Supported
Compliance Management Supported
Device History Not Supported
Due Date Tracking Supported
Gage Management Supported
Label Printing Supported
Measurement Readings Not Supported
Multi-Station Management Not Supported
Out-of-Tolerance Notification Not Supported
Statistical Data Reporting Not 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

AWS Backup Not Supported
AWS Cloud9 Not Supported
Atlassian Rovo Supported
Gmail Not Supported
Jira Supported
Jira Service Management Supported
Microsoft 365 Not Supported
Microsoft Azure Not Supported
Microsoft Outlook Not Supported
SAP Analytics Cloud Not Supported

Integrations

AWS Backup Supported
AWS Cloud9 Supported
Atlassian Rovo Not Supported
Gmail Supported
Jira Not Supported
Jira Service Management Not Supported
Microsoft 365 Supported
Microsoft Azure Supported
Microsoft Outlook Supported
SAP Analytics Cloud Supported
Claim Clearlane CAPA and update features and information
Claim Clearlane CAPA and update features and information
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Claim Qualcy QMS and update features and information