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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.

What is Cognidox ?

Cognidox serves as a comprehensive online document management system tailored for product development in the high-tech, life sciences, and medical device sectors. Available both in the cloud and as an on-premise solution, it fosters effective product lifecycle management and enhances knowledge sharing among developers, clients, partners, and customers alike. This platform is designed to be secure and dependable, offering plug-ins for a variety of programs, including Microsoft Office, and an API that facilitates the integration of numerous processes with Cognidox. At its core, Cognidox functions as a document management system, and it features an add-on that enables the licensing and distribution of documents to third parties through a fully sandboxed website, ensuring that specific documents can be published while maintaining the security of the main storage. Additionally, one of its notable add-ons is the gBMS, or Graphical Business Management System, which utilizes Visio to map out business processes effectively. A robust business management system not only enhances clarity across operations but also contributes to streamlined workflows and improved visibility throughout the organization.

Media

Media

Integrations Supported

Microsoft 365
Microsoft Entra ID

Integrations Supported

Microsoft 365
Salesforce

API Availability

Has API

API Availability

Pricing Information

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

Pricing Information

£10 p/user
We have 3 packages available for hosting, Start up, Scale Up and Enterprise. The Start Up package is the core system for 10 people, if you outgrow that then there is the Scale Up package which is a 20 user minimum at £15 per user for the first 25 users then each user over that is an extra £10 till you reach 100 users after which each user is then just £8.50. For companies over the size of 40 - 50 users we recommend our enterprise package for which we will work with you to get the best fit for your organisation
Free Trial Offered?

Supported Platforms

SaaS
Android
iPhone
iPad
Windows

Supported Platforms

SaaS
On-Prem
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
Web-Based Support

Training Options

Documentation Hub
Online Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

SimplerQMS

Date Founded

2017

Company Location

Denmark

Company Website

www.simplerqms.com

Company Facts

Organization Name

Cognidox Ltd

Date Founded

2008

Company Location

United Kingdom

Company Website

www.cognidox.com

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

Categories and Features

CAPA

Not specified

Compliance

Archiving & Retention
Audit Management
FDA Compliance
ISO Compliance
Sarbanes-Oxley Compliance
Version Control

Document Management

Access Controls
Archiving & Retention
Collaboration Tools
Compliance Tracking
Document Archiving
Document Assembly
Document Indexing
Document Retention
Electronic Signature
File Recovery
File Type Conversion
Forms Management
Full Text Search
Version Control

Document Version Control

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

File Sharing

Audit Trail
Collaboration
Document Management
Electronic Signature
Search
User Management
Version Control
Workflow Management

Forms Automation

Not specified

Human Resources

Not specified

Life Sciences

Not specified

Project Management

Customizable Templates
Milestone Tracking

Quality Management

Corrective and Preventive Actions (CAPA)
Document Control

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