Audience
Certification Bodies, Accreditation Bodies, Standard Setters, Internal and Supplier Audits
About Intact Platform
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
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It is a flexible and modular product with modules in document control, audit management, non-conformance management, customer complaints management, risk management, training management and CAPA management.
It can be configured to meet an organization's specific needs and provides free training and free support.
It has been independently judged to provide the best customer support in its category.
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Verify Technologies
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SimplerQMS
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.
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Dot Compliance QMS
Dot Compliance provides the industry’s first off-the-shelf QMS solution – ready to deploy from day one, with little to no setup required, while also incorporating industry best practices and standards that address the latest global regulatory requirements.
Powered by the Salesforce.com platform, our solutions enable life science organizations to quickly digitize their quality and compliance processes including Document Management, Training Management, Change Control, CAPA, Customer Complaints. Compliant with 21 CFR part 11, EU-Annex 11 and support ISO 9001, 13485, 14971, 27001 & MORE!
Processes included:
▶ Document Management
▶ Training Management
▶ Quality Event Management
▶ CAPA Management
▶ Change Management
▶ Complaint Management
▶ Audit Management
▶ Supplier Quality Management
▶ Risk Management
▶ Design Control
▶ Deviations/Non-conformances
✔ Seamless Install
✔ Cost Effective
✔ One-Stop-Shop
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Pricing
Starting Price:
On request
Pricing Details:
We offer distinct pricing models for small-, mid-, and large-sized companies. Project costs depend on project scope and licensed modules.
Free Trial:
Free Trial available.
Company Information
Intact
Founded: 2001
Austria
intact-systems.com
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Product Details
Platforms Supported
Cloud
Windows
iPhone
iPad
Android
On-Premises
Training
Live Online
Webinars
In Person
Support
Phone Support
Intact Platform Frequently Asked Questions
Intact Platform Product Features
Audit
Alerts / Notifications
Supported
Audit Planning
Supported
Compliance Management
Supported
Dashboard
Supported
Exceptions Management
Supported
Forms Management
Supported
Issue Management
Supported
Mobile Access
Supported
Multi-Year Planning
Supported
Risk Assessment
Supported
Workflow Management
Supported
Compliance
Audit Management
Supported
FDA Compliance
Supported
ISO Compliance
Supported
OSHA Compliance
Supported
Risk Management
Supported
Version Control
Supported
Archiving & Retention
Not Supported
Artificial Intelligence (AI)
Not Supported
Compliance Tracking
Not Supported
Controls Testing
Not Supported
Environmental Compliance
Not Supported
HIPAA Compliance
Not Supported
Incident Management
Not Supported
Sarbanes-Oxley Compliance
Not Supported
Surveys & Feedback
Not Supported
Workflow / Process Automation
Not Supported
Food Traceability
CRM
Supported
Order Management
Supported
Quality Control
Supported
Traceability
Supported
Traceback & Traceforward
Supported
Product Lifecycle Management
Not Supported
Production Management
Not Supported
Recall Management
Not Supported
Recipe Management
Not Supported
Quality Management
Audit Management
Supported
Complaint Management
Supported
Compliance Management
Supported
Corrective and Preventive Actions (CAPA)
Supported
Document Control
Supported
Equipment Management
Supported
ISO Standards Management
Supported
Risk Management
Supported
Supplier Quality Control
Supported
Defect Tracking
Not Supported
Maintenance Management
Not Supported
Training Management
Not Supported
Supply Chain Management
Order Fulfillment
Supported
Supplier Management
Supported
Demand Planning
Not Supported
Electronic Data Interchange
Not Supported
Import / Export Management
Not Supported
Inventory Management
Not Supported
Order Management
Not Supported
Sales & Operations Planning
Not Supported
Shipping Management
Not Supported
Transportation Management
Not Supported
Warehouse Management
Not Supported
