Average Ratings 0 Ratings
Average Ratings 0 Ratings
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
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