SimplerQMS 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.

Pricing

Pricing Starts At:
$13,750/year
Pricing Information:
Everything is included, with no additional costs for implementation, modules, support, hosting, validation, etc.
Free Trial:
Yes

Integrations

API:
Yes, SimplerQMS has an API
View Integrations

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Company Details

Company:
SimplerQMS
Year Founded:
2017
Headquarters:
Denmark
Website:
www.simplerqms.com
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Media

Play Video Change Request for Control of Quality Records SOP Change Request Editing in Microsoft Word CAPA Management Module Views Audit SOP and Electronic Signature Training KPI Report List of Pending Training Assignments

Product Details

Platforms
SaaS
Windows
iPhone
iPad
Android
Type of Training
Documentation
Live Online
Videos
Customer Support
Phone Support
24/7 Live Support
Online

SimplerQMS Features and Options

Quality Management Software

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

Audit Software

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

CAPA Software

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

Compliance Software

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

Document Control Software

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