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features
design
support

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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.

Description

ins2outs is an advanced cloud-based SaaS platform designed for integrated compliance management, enabling organizations to establish, implement, and sustain various management systems such as quality, information security, privacy, environment, and AI within a cohesive framework. By merging robust software with pre-configured "know-how" sets aligned to standards like ISO 13485/21 CFR 820, ISO 27001, ISO 27701, IEC 62304, and ISO 42001, along with expert consulting services, it empowers organizations to create organized documentation—comprising policies, processes, procedures, instructions, and document templates. Additionally, it facilitates workflow management through automated role-based training, timely push notifications, compliance KPIs, customizable documentation logic, version control, and detailed audit trails, all securely hosted in the cloud. Users benefit from the ability to operate interconnected systems that fulfill various regulatory and standard obligations, while collaboratively managing electronic documentation with built-in traceability and export capabilities. This comprehensive approach not only enhances compliance but also streamlines operational efficiency across different regulatory environments.

API Access

Has API

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

GitLab
Microsoft 365
Microsoft Entra ID
Microsoft Teams
OpenAI
Slack

Integrations

GitLab
Microsoft 365
Microsoft Entra ID
Microsoft Teams
OpenAI
Slack

Pricing Details

$13,750/year
Free Trial
Free Version

Pricing Details

$25 per month
Free Trial
Free Version

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Vendor Details

Company Name

SimplerQMS

Founded

2017

Country

Denmark

Website

www.simplerqms.com

Vendor Details

Company Name

ins2outs

Country

Poland

Website

ins2outs.com

Product Features

Audit

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

CAPA

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

Compliance

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

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

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

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