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About

Qualtrax is a complete quality and compliance software system used to manage and control documentation, automate key business processes with customizable workflows, streamline training management, manage internal and external audits and ensure critical industry regulations are addressed in real-time. Qualtrax is an invaluable resource in heavily-regulated industries, where complying with standards including ISO 17025, 17020, 13485, and 9001, TNI, GFSI, FDA, and FQS is required.

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 Supported
Mac Supported
Linux Not Supported
Cloud Supported
On-Premises Not Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported

Platforms Supported

Windows Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Not Supported
iPhone Supported
iPad Supported
Android Supported
Chromebook Not Supported

Audience

Quality and Compliance professionals

Audience

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

Support

Phone Support Supported
24/7 Live Support Supported
Online Supported

Support

Phone Support Supported
24/7 Live Support Supported
Online Supported

API

Offers API Not Supported

API

Offers API Supported

Screenshots and Videos

Screenshots and Videos

Pricing

Pricing is determined on a per-user basis, with multiple license types available. Please contact us for a quote regarding your specific situation.
Free Version Not Supported
Free Trial Supported

Pricing

$13,750/year
Everything is included, with no additional costs for implementation, modules, support, hosting, validation, etc.
Free Version Not Supported
Free Trial Supported

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:

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Reviews/Ratings

Overall 1.0 / 5
ease 1.0 / 5
features 1.0 / 5
design 1.0 / 5
support 2.0 / 5

Pros & Cons from Real Users

Pros

  • The technical staff were the best part of our experience. During onboarding they made a real effort to explain how the system works and to help whenever we had questions, and they were responsive and patient throughout. The platform is built on Microsoft Azure and Microsoft 365, so documents live in a familiar SharePoint/Office environment rather than in a completely proprietary system.

Cons

  • In our experience the system is extremely inconvenient, cumbersome and inflexible. Everyday document work requires far more clicks and steps than it should, the interface is heavy, and adapting the workflows to how our company actually operates proved impractical. After evaluating it we decided not to implement it at all. The far bigger problem is the commercial side. Read the termination and renewal provisions extremely carefully before signing. Based on our experience you cannot simply stop using the service during the contract year and stop paying. Notice must be given at least 90 days before the renewal date; miss that deadline and you may be invoiced for another full contractual period even though you no longer use the system. Termination must be submitted in writing and its receipt expressly confirmed. We told the company twice by telephone that we wanted to discontinue the service, and those conversations were not treated as formal notice. Do not rely on phone calls: send written notice, request written confirmation, and keep all correspondence.

Training

Documentation Supported
Webinars Supported
Live Online Supported
In Person Supported

Training

Documentation Supported
Webinars Not Supported
Live Online Supported
In Person Not Supported

Company Information

Qualtrax
Founded: 1993
United States
www.qualtrax.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.
Dot Compliance QMS

Dot Compliance QMS

QMS for Life Sciences
Dot Compliance QMS

Dot Compliance QMS

QMS for Life Sciences
QT9 QMS

QT9 QMS

QT9 Software

Categories

Audit Supported
Compliance Supported
Document Control Supported
ISO Compliance Supported
Quality Management Supported

Categories

Audit Supported
CAPA Supported
Compliance Supported
Document Control Supported
ISO Compliance Supported
Quality Management Supported

Audit Features

Alerts / Notifications Supported
Audit Planning Supported
Compliance Management Supported
Dashboard Supported
Exceptions Management Not Supported
Forms Management Not Supported
Issue Management Supported
Mobile Access Supported
Multi-Year Planning Not Supported
Risk Assessment Supported
Workflow Management Supported

Compliance Features

Archiving & Retention Supported
Artificial Intelligence (AI) Not Supported
Audit Management Supported
Compliance Tracking Supported
Controls Testing Not Supported
Environmental Compliance Supported
FDA Compliance Supported
HIPAA Compliance Not Supported
Incident Management Supported
ISO Compliance Supported
OSHA Compliance Supported
Risk Management Supported
Sarbanes-Oxley Compliance Not Supported
Surveys & Feedback Not Supported
Version Control Supported
Workflow / Process Automation Supported

Document Control Features

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

Quality Management Features

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

Accreditation Management Features

Collaboration Supported
Compliance Management Supported
Document Management Supported
Higher Education Supported
Requirements Management Supported
Reviewer Portal Not Supported
Self Assessment Supported
User Access Permissions Supported
Workflow Management Supported

Document Management Features

Access Controls Supported
Archiving & Retention Supported
Collaboration Tools Supported
Compliance Tracking Supported
Document Archiving Supported
Document Assembly Supported
Document Capture Not Supported
Document Conversion Supported
Document Delivery Supported
Document Indexing Supported
Document Retention Supported
Electronic Signature Supported
Email Management Supported
File Recovery Supported
File Type Conversion Supported
Forms Management Supported
Full Text Search Supported
Offline Access Supported
Optical Character Recognition Supported
Print Management Supported
Version Control Supported

Document Version Control Features

Access Controls/Permissions Supported
Approval Process Control Supported
Archiving & Retention Supported
Audit Trail Supported
Commenting / Notes Supported
Document Check-in / Check-out Supported
For Engineering Documents Supported
Revision History Supported
Version Comparison Supported
Version Rollback Supported

Audit Features

Alerts / Notifications Supported
Audit Planning Supported
Compliance Management Supported
Dashboard Supported
Exceptions Management Not Supported
Forms Management Supported
Issue Management Supported
Mobile Access Supported
Multi-Year Planning Not Supported
Risk Assessment Supported
Workflow Management Supported

Compliance Features

Archiving & Retention Supported
Artificial Intelligence (AI) Not Supported
Audit Management Supported
Compliance Tracking Not Supported
Controls Testing Not Supported
Environmental Compliance Not Supported
FDA Compliance Supported
HIPAA Compliance Supported
Incident Management Not Supported
ISO Compliance Supported
OSHA Compliance Not Supported
Risk Management Supported
Sarbanes-Oxley Compliance Not Supported
Surveys & Feedback Not Supported
Version Control Supported
Workflow / Process Automation Supported

Document Control Features

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

Quality Management Features

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

CAPA Features

Audit Management Supported
CAPA Planning Supported
Change Management Supported
Complaint Management Supported
Incident Management Supported
Nonconformance Tracking Supported
Quality Control Supported
Risk Management Supported
Root Cause Analysis Not Supported
Training Management Supported

Integrations

Microsoft 365 Supported
Brandwatch Supported
Microsoft Entra ID Not Supported

Integrations

Microsoft 365 Supported
Brandwatch Not Supported
Microsoft Entra ID Supported
Claim Qualtrax and update features and information
Claim Qualtrax and update features and information
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Claim SimplerQMS and update features and information