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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.

About

ins2outs is a cloud-based SaaS integrated compliance management platform that empowers organizations to define, operate, and maintain multiple management systems, such as quality, information security, privacy, environment, and AI, within a single unified environment by combining powerful software, pre-built “know-how” sets mapped to standards like ISO 13485/21 CFR 820, ISO 27001, ISO 27701, IEC 62304, and ISO 42001, and expert consulting services. It helps organizations build structured documentation, including policies, processes, procedures, instructions, and document templates, and manage workflows with automated role-based training, push notifications, compliance KPIs, configurable documentation logic, version control, and audit trails, all hosted securely in the cloud. Users can operate integrated systems that address multiple regulatory and standard requirements, manage electronic documentation collaboratively with traceability and export options.

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Audience

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

Audience

Compliance, quality, and regulatory teams searching for a tool to define, operate, and prove integrated management systems and regulatory compliance

Support

Phone Support
24/7 Live Support
Online

Support

Phone Support
24/7 Live Support
Online

API

Offers API

API

Offers API

Screenshots and Videos

Screenshots and Videos

Pricing

$13,750/year
Free Version
Free Trial

Pricing

$25 per month
Free Version
Free Trial

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:

Review this Software

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:

Review this Software

Training

Documentation
Webinars
Live Online
In Person

Training

Documentation
Webinars
Live Online
In Person

Company Information

SimplerQMS
Founded: 2017
Denmark
www.simplerqms.com

Company Information

ins2outs
Poland
ins2outs.com

Alternatives

isoTracker Quality Management

isoTracker Quality Management

isoTracker Solutions Ltd

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QEdge

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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
ISMS.online

ISMS.online

Alliantist

Categories

Categories

Audit Features

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

CAPA Features

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

Compliance Features

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

Document Control Features

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

Quality Management Features

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

Integrations

GitLab
Microsoft 365
Microsoft Entra ID
Microsoft Teams
OpenAI
Slack

Integrations

GitLab
Microsoft 365
Microsoft Entra ID
Microsoft Teams
OpenAI
Slack
Claim SimplerQMS and update features and information
Claim SimplerQMS and update features and information
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Claim ins2outs and update features and information