Average Ratings 1 Rating

Total
ease
features
design
support

Average Ratings 1 Rating

Total
ease
features
design
support

Description

Food Safety Software allows for cost-effective transformation in food safety, NPD and customer complaints, as well as supply chain transparency. Our food safety software includes VACCP/TACCP and horizon scanning to help you save time and complete consistent, auditable risk assessment of suppliers and products. You will never be audited in non-conformance and you can be audit-ready 24 hours a day. Transform specification management for raw materials and finished products, and answer customer queries instantly. Automate supplier quality monitoring and internal non-conformance management using automated workflows. This will ensure that non-conformances are promptly closed. Our team will manage all complaints using market-leading software. This will save you time, money, and improve customer service. You can launch new products faster and better together, while still meeting all safety, legality, and profitability requirements.

Description

SimplerQMS offers a cloud-based Quality Management Software, specifically designed for the Life Science industry. SimplerQMS helps ensure compliance with various regulatory requirements, including FDA 21 CFR Part 11, EU Annex 11, GxP, cGMP, GAMP 5, GDPR, EU IVDR & EU MDR, ISO 13485:2016, 21 CFR Part 820, and ICH Q10, among others. The system is fully validated according to GAMP5. The system offers a range of Life Science QMS modules such as Document Control, Change Control, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, Quality KPIs and more. SimplerQMS integrates with Microsoft Office and allows users to work with documents in applications such as Word, PowerPoint, and Excel. Overall, SimplerQMS delivers efficient, paperless workflows that align with the compliance requirements of the Life Science industry.

API Access

Has API No 

API Access

Has API Yes 

Screenshots View All

Screenshots View All

Integrations

Microsoft 365 No 
Microsoft Entra ID No 

Integrations

Microsoft 365 Yes 
Microsoft Entra ID Yes 

Pricing Details

No price information available.
Free Trial Yes 
Free Version No 

Pricing Details

$13,750/year
Everything is included, with no additional costs for implementation, modules, support, hosting, validation, etc.
Free Trial Yes 
Free Version No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App Yes 
iPad App Yes 
Android App Yes 
Windows No 
Mac No 
Linux No 
Chromebook No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App Yes 
iPad App Yes 
Android App Yes 
Windows Yes 
Mac No 
Linux No 
Chromebook No 

Customer Support

Business Hours Yes 
Live Rep (24/7) No 
Online Support Yes 

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 No 
Live Training (Online) Yes 
In Person No 

Vendor Details

Company Name

QADEX

Founded

2006

Country

United Kingdom

Website

www.qadex.com

Vendor Details

Company Name

SimplerQMS

Founded

2017

Country

Denmark

Website

www.simplerqms.com

Product Features

Complaint Management

Case Management No 
Complaint Classification No 
Corrective Actions (CAPA) No 
Customer Complaint Tracking No 
Feedback Management No 
Forms Management No 
Issue Tracking No 
Quality Assurance Management No 
Routing No 
Self Service Portal No 
Social Media Monitoring No 
Survey Management No 

Food Traceability

CRM No 
Order Management No 
Product Lifecycle Management No 
Production Management No 
Quality Control No 
Recall Management No 
Recipe Management No 
Traceability No 
Traceback & Traceforward No 

Product Lifecycle Management

Change Management No 
Compliance Management No 
Cost Tracking No 
Design Management No 
Document Management No 
Product Data Management No 
Project Management No 
Requirements Management No 
Supplier Management No 

Quality Management

Audit Management No 
Complaint Management Yes 
Compliance Management No 
Corrective and Preventive Actions (CAPA) Yes 
Defect Tracking No 
Document Control Yes 
Equipment Management Yes 
ISO Standards Management No 
Maintenance Management No 
Risk Management No 
Supplier Quality Control No 
Training Management No 

Supply Chain Management

Demand Planning No 
Electronic Data Interchange No 
Import / Export Management No 
Inventory Management No 
Order Fulfillment Yes 
Order Management No 
Sales & Operations Planning No 
Shipping Management No 
Supplier Management No 
Transportation Management No 
Warehouse Management No 

Vendor Management

Audit Management No 
Contact Management No 
Customer Database No 
Self Service Portal No 
Supplier Master Data No 
Transaction History No 
Vendor Maintained Profiles No 
Vendor Managed Inventory No 
Vendor Performance Rating No 
Vendor Qualification Tracking No 

Product Features

Audit

Alerts / Notifications Yes 
Audit Planning Yes 
Compliance Management Yes 
Dashboard Yes 
Exceptions Management No 
Forms Management Yes 
Issue Management Yes 
Mobile Access Yes 
Multi-Year Planning No 
Risk Assessment Yes 
Workflow Management Yes 

CAPA

Audit Management Yes 
CAPA Planning Yes 
Change Management Yes 
Complaint Management Yes 
Incident Management Yes 
Nonconformance Tracking Yes 
Quality Control Yes 
Risk Management Yes 
Root Cause Analysis No 
Training Management Yes 

Compliance

Archiving & Retention Yes 
Artificial Intelligence (AI) No 
Audit Management Yes 
Compliance Tracking No 
Controls Testing No 
Environmental Compliance No 
FDA Compliance Yes 
HIPAA Compliance Yes 
ISO Compliance Yes 
Incident Management No 
OSHA Compliance No 
Risk Management Yes 
Sarbanes-Oxley Compliance No 
Surveys & Feedback No 
Version Control Yes 
Workflow / Process Automation Yes 

Document Control

Archiving & Retention Yes 
Automated Routing Yes 
Change Management Yes 
Compliance Management Yes 
Electronic Signature Yes 
Escalation Management Yes 
Periodic Review Yes 
Version Control Yes 

Quality Management

Audit Management Yes 
Complaint Management Yes 
Compliance Management Yes 
Corrective and Preventive Actions (CAPA) Yes 
Defect Tracking Yes 
Document Control Yes 
Equipment Management Yes 
ISO Standards Management Yes 
Maintenance Management Yes 
Risk Management Yes 
Supplier Quality Control Yes 
Training Management Yes 

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