Average Ratings 0 Ratings
Average Ratings 0 Ratings
Description
Carizma QM is an online application designed to assist users in overseeing the complete lifecycle of regulated documents, encompassing stages from drafting and reviewing to approving, releasing, and archiving. It enables the creation and management of essential documents, such as Standard Operating Procedures (SOPs), through integrated workflows that facilitate the review and approval process. Upon approval, the system automatically initiates a training workflow where users must acknowledge they have read and understood the document. The software incorporates an electronic signature feature that complies with 21 CFR Part 11 regulations, ensuring a display of users who have acknowledged their understanding of the documents. Additionally, it maintains a validated audit trail, enhancing users' ability to manage regulated documents directly within Carizma QM. Authors can specify crucial information, including the document type (such as SOP, work instruction, form, or checklist), the document title, the process owner (the relevant department), and the user groups to which the document applies, along with setting a review cycle. Users are notified via email in a timely manner when a document requires their review, and Carizma QM generates the initial document framework to streamline this process. Overall, the software simplifies and enhances the management of regulated documentation through its comprehensive features.
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
Adobe Acrobat
Yes
Atlassian Rovo
No
Confluence
No
Microsoft Word
Yes
Integrations
Adobe Acrobat
No
Atlassian Rovo
Yes
Confluence
Yes
Microsoft Word
No
Pricing Details
No price information available.
Free Trial
No
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
Yes
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
Axicos
Founded
2007
Country
Switzerland
Website
www.axicos.com/software-solutions
Vendor Details
Company Name
Clearlane Apps
Founded
2026
Country
France
Website
clearlaneapps.com/controlled-documents/
Product Features
Legal Document Management
Access Controls
No
Archiving & Retention
No
Collaboration
No
Contract Management
No
Document Assembly
No
Document Indexing
No
Document Tagging
No
Full Text Search
No
Version Control
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