Average Ratings 0 Ratings
Average Ratings 0 Ratings
Description
AmpleLogic EDMS Software serves as a robust electronic document management solution tailored specifically for the Pharmaceutical and Biotech sectors, crafted to address the stringent cGMP requirements of the Pharma industry while ensuring compliance with both 21CFR Part 11 and EU Annex 11, effectively resolving the myriad challenges encountered by various organizations. This paperless document management system allows users to seamlessly manage and interact with all types of documents and information with ease. Key functionalities of the AmpleLogic Document Management System include document creation, review, approval, editing, document comparison, version control, and the ability to conduct parallel reviews, all designed to enhance operational efficiency and compliance. By integrating these features, AmpleLogic EDMS not only streamlines workflows but also significantly reduces the risk of errors in document handling.
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
Screenshots View All
No images available
Integrations
AmpleLogic LCNC Platform
No
Atlassian Rovo
Yes
Confluence
Yes
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
Yes
iPhone App
No
iPad App
No
Android App
No
Windows
Yes
Mac
Yes
Linux
Yes
Chromebook
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
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)
Yes
In Person
Yes
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
No
In Person
No
Vendor Details
Company Name
AmpleLogic
Founded
2010
Country
India
Website
amplelogic.com
Vendor Details
Company Name
Clearlane Apps
Founded
2026
Country
France
Website
clearlaneapps.com/controlled-documents/
Product Features
Document Management
Access Controls
No
Archiving & Retention
No
Collaboration Tools
No
Compliance Tracking
No
Document Archiving
No
Document Assembly
No
Document Capture
No
Document Conversion
No
Document Delivery
No
Document Indexing
No
Document Retention
No
Electronic Signature
No
Email Management
No
File Recovery
No
File Type Conversion
No
Forms Management
No
Full Text Search
No
Offline Access
No
Optical Character Recognition
No
Print Management
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
Alternatives
Alternatives
No Alternatives