Average Ratings 0 Ratings
Average Ratings 0 Ratings
Description
Clearlane CAPA is an innovative app designed for Jira Cloud, specifically tailored for teams involved in quality and regulatory compliance within sectors such as medical devices, pharmaceuticals, and ISO 9001 manufacturing. It allows for the transformation of existing Jira work items—such as complaints, nonconformities, deviations, and audit findings—into CAPAs without the need for additional issue types, workflows, or fields. The application facilitates a structured process that encompasses containment measures, a Five Whys root-cause analysis, the formulation of a signed action plan, connections to Jira actions, and a scheduled effectiveness evaluation; if the effectiveness check is deemed insufficient, it loops back to the root-cause analysis phase. Users have the ability to review related CAPAs, utilize JQL for CAPA data searches, export information to CSV format, and create PDF documentation that includes workflow history, actions taken, signatures, and a comprehensive audit trail. Additionally, CAPAs can be initiated directly from requests made through Jira Service Management, and a read-only Rovo agent is available to field inquiries regarding CAPA records. Built upon the Atlassian Forge platform, this app ensures that all records are securely maintained within the customer’s Atlassian environment, providing a seamless integration experience. This unique approach enhances the efficiency and effectiveness of quality management processes for teams in regulated industries.
Description
Clearlane Controlled Documents integrates document control specifically designed for quality management systems within Confluence Cloud, effectively transforming standard pages like SOPs, work instructions, and policies into regulated documents. Each revision is authenticated by named approvers who utilize a unique personal signing password; the electronic signature is intricately linked to the content through a SHA-256 fingerprint, ensuring that any edits made during the review process invalidate the signature. Once the final signature is obtained, the revision is deemed effective and assigned a subsequent review date. Readers assure themselves of the current revision, periodic reviews activate reminder notifications, and a register maintains a record of all documents within each space. Users have the capability to create a comprehensive evidence PDF that includes signatures, revision history, read confirmations, and the audit trail. This application caters to teams in pharma, biotech, medtech, and ISO 9001 quality sectors, and it is available in English, French, and German languages. It also assists teams in adhering to regulations such as 21 CFR Part 11, EU GMP Annex 11, and ISO 13485 standards. Developed on the Atlassian Forge platform, it securely stores data within the customer's own Atlassian environment, ensuring both compliance and data integrity. Additionally, it offers an intuitive interface that simplifies the management of controlled documents for users across various industries.
API Access
Has API
No
API Access
Has API
No
Integrations
Atlassian Rovo
Yes
Confluence
No
Jira
Yes
Jira Service Management
Yes
Integrations
Atlassian Rovo
Yes
Confluence
Yes
Jira
No
Jira Service Management
No
Pricing Details
$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 Trial
Yes
Free Version
No
Pricing Details
$0
Free for up to 10 users. Larger teams pay per user, billed by Atlassian through the Marketplace.
Free Trial
Yes
Free Version
Yes
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Customer Support
Business Hours
No
Live Rep (24/7)
No
Online Support
Yes
Customer Support
Business Hours
No
Live Rep (24/7)
No
Online Support
Yes
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
No
In Person
No
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
No
In Person
No
Vendor Details
Company Name
Clearlane Apps
Founded
2026
Country
France
Website
clearlaneapps.com/capa/
Vendor Details
Company Name
Clearlane Apps
Founded
2026
Country
France
Website
clearlaneapps.com/controlled-documents/
Product Features
CAPA
Audit Management
No
CAPA Planning
No
Change Management
No
Complaint Management
No
Incident Management
No
Nonconformance Tracking
No
Quality Control
No
Risk Management
No
Root Cause Analysis
No
Training Management
No
Product Features
Document Control
Archiving & Retention
No
Automated Routing
No
Change Management
No
Compliance Management
No
Electronic Signature
No
Escalation Management
No
Periodic Review
No
Version Control
No