Ratings and Reviews 0 Ratings

Total
ease
features
design
support

This software has no reviews. Be the first to write a review.

Write a Review

Ratings and Reviews 1 Rating

Total
ease
features
design
support

Alternatives to Consider

  • HSI Donesafe Reviews & Ratings
    176 Ratings
    Company Website
  • Intelex Reviews & Ratings
    193 Ratings
    Company Website
  • Certainty Software Reviews & Ratings
    93 Ratings
  • SBS Quality Management Software Reviews & Ratings
    7 Ratings
    Company Website
  • Interfacing Integrated Management System (IMS) Reviews & Ratings
    66 Ratings
    Company Website
  • AlisQI Reviews & Ratings
    108 Ratings
    Company Website
  • isoTracker Quality Management Reviews & Ratings
    19 Ratings
    Company Website
  • Qualio Reviews & Ratings
    919 Ratings
    Company Website
  • Mitti (by SafetyCulture) Reviews & Ratings
    869 Ratings
    Company Website
  • Predict360 Reviews & Ratings
    18 Ratings
    Company Website

What is Xybion QMS?

Quickly revolutionize your compliance, quality, and risk management frameworks in an entirely digital and remote environment. Anticipate, reduce, and automate real-time compliance oversight, ensuring you are consistently ready for any compliance audits that may arise. In this fast-paced landscape, staying proactive is essential for success.

What is SimplerQMS?

SimplerQMS provides a cloud-centric Quality Management Software tailored specifically for the Life Science sector. This innovative platform ensures adherence to an array of regulatory standards, 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, and is fully validated under GAMP5 guidelines. The software encompasses a comprehensive suite of Life Science QMS modules, including Document Control, Change Control, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, and Quality KPIs, among additional functionalities. Moreover, SimplerQMS seamlessly integrates with Microsoft Office, enabling users to manage documents within familiar applications like Word, PowerPoint, and Excel. In summary, SimplerQMS not only streamlines operations through efficient, paperless workflows but also ensures that organizations can meet the stringent compliance mandates essential in the Life Science industry. Furthermore, its user-friendly interface and robust capabilities make it an indispensable tool for companies looking to enhance their quality management processes.

Media

Media

Integrations Supported

Integrations Supported

Microsoft 365
Microsoft Entra ID

API Availability

API Availability

Has API

Pricing Information

Per user and server-based pricing
Free Trial Offered?

Pricing Information

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

Supported Platforms

SaaS
Windows

Supported Platforms

SaaS
Android
iPhone
iPad
Windows

Customer Service / Support

Standard Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Online Training

Company Facts

Organization Name

Xybion

Date Founded

1977

Company Location

United States

Company Website

www.xybion.com

Company Facts

Organization Name

SimplerQMS

Date Founded

2017

Company Location

Denmark

Company Website

www.simplerqms.com

Categories and Features

CAPA

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

Compliance

Audit Management
Compliance Tracking
FDA Compliance
ISO Compliance
Incident Management
Risk Management
Sarbanes-Oxley Compliance
Version Control

Quality Management

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

Risk Management

Alerts/Notifications
Auditing
Compliance Management
Corrective Actions (CAPA)
Dashboard
Internal Controls Management
Mobile Access
Operational Risk Management
Risk Assessment

Categories and Features

Audit

Alerts / Notifications
Audit Planning
Compliance Management
Dashboard
Forms Management
Issue Management
Mobile Access
Risk Assessment
Workflow Management

CAPA

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

Compliance

Archiving & Retention
Audit Management
FDA Compliance
HIPAA Compliance
ISO Compliance
Risk Management
Version Control
Workflow / Process Automation

Document Control

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

ISO Compliance

Not specified

Quality Management

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

Popular Alternatives

Popular Alternatives

isoTracker Quality Management Reviews & Ratings

isoTracker Quality Management

isoTracker Solutions Ltd
QEdge Reviews & Ratings

QEdge

Sarjen Systems Pvt Ltd
ZEBSOFT Reviews & Ratings

ZEBSOFT

Zebra Software
QualityPro by TecWork Reviews & Ratings

QualityPro by TecWork

TecWork Global Business Solutions Pvt. Ltd.
Dot Compliance QMS Reviews & Ratings

Dot Compliance QMS

QMS for Life Sciences