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features
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support

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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 

Screenshots View All

Screenshots View All

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 

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