Average Ratings 0 Ratings

Total
ease
features
design
support

No User Reviews. Be the first to provide a review:

Write a Review

Average Ratings 1 Rating

Total
ease
features
design
support

Description

The Intact Platform, a cloud-based and on-premise Enterprise Resource Planning solution (ERP), is the best for audits, assessments certification, accreditation, and other standards. It is more than any other audit collection tool on the market. It offers a complete solution that helps you manage communications and business goals as well as personnel. Intact Platform is unrivaled in functionality and features an end-to-end modular workflow that is easily scaleable. 34% efficiency increase on average (upto 60+%) Unmatched modularity, flexibility and scalability All standards and audit services Digital workflow - no need for paper Remote and on-site auditing Non-conformities and corrective actions Planning and risk-based auditing Communication with clients is easy Reporting and business intelligence (BI). Management and central data hub (incl. Audit trail complete Innovation never stops

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 Yes 

API Access

Has API Yes 

Screenshots View All

Screenshots View All

Integrations

Microsoft 365 Yes 
Azure Storage Yes 
ComponentOne Yes 
Conholdate.Total For .NET Yes 
Conholdate.Total for Java Yes 
GitHub Yes 
Google Maps Yes 
Highcharts Yes 
Microsoft Entra ID No 
Pimberly Yes 
SQLite Yes 

Integrations

Microsoft 365 Yes 
Azure Storage No 
ComponentOne No 
Conholdate.Total For .NET No 
Conholdate.Total for Java No 
GitHub No 
Google Maps No 
Highcharts No 
Microsoft Entra ID Yes 
Pimberly No 
SQLite No 

Pricing Details

On request
We offer distinct pricing models for small-, mid-, and large-sized companies. Project costs depend on project scope and licensed modules.
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 Yes 
iPhone App Yes 
iPad App Yes 
Android App Yes 
Windows Yes 
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 No 

Customer Support

Business Hours Yes 
Live Rep (24/7) Yes 
Online Support Yes 

Types of Training

Training Docs No 
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

Intact

Founded

2001

Country

Austria

Website

intact-systems.com

Vendor Details

Company Name

SimplerQMS

Founded

2017

Country

Denmark

Website

www.simplerqms.com

Product Features

Audit

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

Compliance

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

Food Traceability

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

Quality Management

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

Alternatives

Alternatives

QEdge Reviews

QEdge

Sarjen Systems Pvt Ltd
isoTracker Quality Management Reviews

isoTracker Quality Management

isoTracker Solutions Ltd
Intelex Reviews

Intelex

Intelex Technologies
Dot Compliance QMS Reviews

Dot Compliance QMS

QMS for Life Sciences
QualityPro by TecWork Reviews

QualityPro by TecWork

TecWork Global Business Solutions Pvt. Ltd.