Average Ratings 0 Ratings
Average Ratings 0 Ratings
Description
CLEEN, a trusted software for proactive cleaning validation, is a global leader in digitalizing cleaning compliance processes. CLEEN is used by some of the most prestigious pharma companies around the world. It has helped to resolve regulatory observations and set a gold standard in cleaning validation.
CLEEN is a preferred choice for regulators. It brings consistency, accuracy and harmonization to Cleaning Procedures from beginning to end.
Description
SoftGroup is a global software firm that specializes in providing comprehensive traceability solutions tailored for the pharmaceutical sector. With 17 years of industry presence, we have earned a reputation as a trusted partner for serialization and aggregation solutions, catering to both major pharmaceutical corporations with extensive production capabilities and smaller Marketing Authorization Holders (MAHs) lacking significant manufacturing operations. By choosing SoftGroup, you align yourself with numerous small to medium-sized pharmaceutical producers, contract manufacturers, parallel importers, and distributors that share your commitment to excellence. Our flagship product, SoftGroup® SaTT Gateway, stands out as the most intuitive and fully automated SaaS application designed to ensure compliance with traceability and serialization standards. It seamlessly meets the EU FMD and MDLP regulations, along with other current and forthcoming compliance mandates that impact all participants in the supply chain, including manufacturers, wholesalers, repackagers, and third-party logistics providers. Moreover, our solutions are consistently updated to adapt to the evolving regulatory landscape, ensuring that your operations remain compliant and efficient.
API Access
Has API
Yes
API Access
Has API
No
Integrations
FactoryTalk
Yes
SAP Cloud Platform
Yes
SAP ERP
Yes
TrackWise
Yes
Integrations
FactoryTalk
No
SAP Cloud Platform
No
SAP ERP
No
TrackWise
No
Pricing Details
No price information available.
Free Trial
Yes
Free Version
Yes
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
Yes
iPad App
No
Android App
Yes
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
No
Customer Support
Business Hours
Yes
Live Rep (24/7)
Yes
Online Support
Yes
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
Yes
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
Yes
Vendor Details
Company Name
Leucine
Founded
2015
Country
United States
Website
www.leucinetech.com
Vendor Details
Company Name
SoftGroup
Founded
2020
Country
Bulgaria
Website
www.softgroup.eu/
Product Features
Compliance
Archiving & Retention
Yes
Artificial Intelligence (AI)
No
Audit Management
Yes
Compliance Tracking
Yes
Controls Testing
Yes
Environmental Compliance
No
FDA Compliance
Yes
HIPAA Compliance
No
ISO Compliance
Yes
Incident Management
Yes
OSHA Compliance
No
Risk Management
Yes
Sarbanes-Oxley Compliance
No
Surveys & Feedback
No
Version Control
Yes
Workflow / Process Automation
Yes
Product Features
Pharmacy
Automatic Refills
No
Barcode Generation
No
Claims Management
No
Compounding
No
E-Prescribing
No
Electronic Signature
No
Forms Management
No
Insurance Processing
No
Inventory Management
No
Multi-Store Management
No
Online Refills
No
Pill Database
No
Pill Imaging
No
Point of Sale (POS)
No
Prescription Processing
No
Rx Image Scanning
No
Signature Capture
No