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About

The Intact Platform is the leading cloud and on-premise Enterprise Resource Planning (ERP) solution for audits, assessments, certification, accreditation, and standards worldwide. It goes beyond other audit collection tools on the market with a full solution approach that helps you manage communications, business goals, and personnel. The Intact Platform is unsurpassed in functionality and features a fully modular end-to-end workflow that is easily scalable. ✓ 34% increase in efficiency on average (up to 60+%) ✓ Unmatched modularity, flexibility, and scalability ✓ All standards and audit services ✓ Digital workflow – no paper ✓ On-site and remote auditing ✓ Non-conformities & corrective actions ✓ Risk-based auditing & planning ✓ Easy client communication ✓ Reporting & business intelligence (BI) ✓ Central data and management hub (incl. full audit trail) ✓ Nonstop innovation

About

SimplerQMS offers a cloud-based Quality Management Software that is fully validated according to GAMP5 and specifically designed for the Life Science industry. This comprehensive QMS platform 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, ICH Q10, and others. The software offers a wide range of Life Science QMS modules, such as Document Control, Change Management, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, Quality KPIs, among others, ensuring a seamless experience. SimplerQMS enhances document handling by allowing users to work directly in Microsoft Office applications like Word, PowerPoint, and Excel.

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Audience

Certification Bodies, Accreditation Bodies, Standard Setters, Internal and Supplier Audits

Audience

Companies in the Life Science industries - Medical Device, Pharmaceutical, Biotechnology, Laboratory, and others.

Support

Phone Support
24/7 Live Support
Online

Support

Phone Support
24/7 Live Support
Online

API

Offers API

API

Offers API

Screenshots and Videos

Screenshots and Videos

Pricing

On request
We offer distinct pricing models for small-, mid-, and large-sized companies. Project costs depend on project scope and licensed modules.
Free Version
Free Trial

Pricing

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

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Training

Documentation
Webinars
Live Online
In Person

Training

Documentation
Webinars
Live Online
In Person

Company Information

Intact
Founded: 2001
Austria
intact-systems.com

Company Information

SimplerQMS
Founded: 2017
Denmark
www.simplerqms.com

Alternatives

Alternatives

isoTracker Quality Management

isoTracker Quality Management

isoTracker Solutions Ltd
QEdge

QEdge

Sarjen Systems Pvt Ltd
QualityPro by TecWork

QualityPro by TecWork

TecWork Global Business Solutions Pvt. Ltd.
Intelex

Intelex

Intelex Technologies
Dot Compliance QMS

Dot Compliance QMS

QMS for Life Sciences
Radley Traceability

Radley Traceability

Radley Corporation
QT9 QMS

QT9 QMS

QT9 Software

Categories

Categories

Audit Features

Alerts / Notifications
Audit Planning
Compliance Management
Dashboard
Exceptions Management
Forms Management
Issue Management
Mobile Access
Multi-Year Planning
Risk Assessment
Workflow Management

Compliance Features

Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
Incident Management
ISO Compliance
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation

Quality Management Features

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

Food Traceability Features

CRM
Order Management
Product Lifecycle Management
Production Management
Quality Control
Recall Management
Recipe Management
Traceability
Traceback & Traceforward

Supply Chain Management Features

Demand Planning
Electronic Data Interchange
Import / Export Management
Inventory Management
Order Fulfillment
Order Management
Sales & Operations Planning
Shipping Management
Supplier Management
Transportation Management
Warehouse Management

Audit Features

Alerts / Notifications
Audit Planning
Compliance Management
Dashboard
Exceptions Management
Forms Management
Issue Management
Mobile Access
Multi-Year Planning
Risk Assessment
Workflow Management

Compliance Features

Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
Incident Management
ISO Compliance
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation

Quality Management Features

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

CAPA Features

Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management

Document Control Features

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

Integrations

Microsoft 365
Azure Storage
ComponentOne
Conholdate.Total For .NET
Conholdate.Total for Java
GitHub
Google Maps
Highcharts
Microsoft Entra ID
Pimberly
SQLite

Integrations

Microsoft 365
Azure Storage
ComponentOne
Conholdate.Total For .NET
Conholdate.Total for Java
GitHub
Google Maps
Highcharts
Microsoft Entra ID
Pimberly
SQLite
Claim Intact Platform and update features and information
Claim Intact Platform and update features and information
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