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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
SmartISO is a cloud-based platform designed for compliance and quality management, specifically tailored for organizations that oversee ISO systems on their own. It consolidates various functions such as document control, internal audits, corrective and preventive actions (CAPA), risk management, training records, management reviews, supplier assessments, and quality dashboards into a singular workspace. This enables teams to effectively coordinate activities related to quality, environmental concerns, and occupational health and safety, ensuring that workflows comply with ISO standards. The platform also incorporates AI-driven features that assist in drafting and analyzing documents, allowing users to review generated content easily. SmartISO is targeted towards quality and health, safety, and environmental (HSE) managers, compliance teams, and ISO consultants within small to mid-sized enterprises. Subscription plans are available that differ based on standards, storage capacity, AI features, and additional functionalities, and users can take advantage of a 14-day free trial to explore its offerings further. With its user-friendly interface and comprehensive tools, SmartISO aims to enhance the efficiency of compliance management across various industries.
API Access
Has API
Yes
API Access
Has API
Yes
Screenshots View All
No images available
Integrations
Microsoft 365
No
Microsoft Entra ID
No
Pricing Details
$13,750/year
Everything is included, with no additional costs for implementation, modules, support, hosting, validation, etc.
Free Trial
Yes
Free Version
No
Pricing Details
$39/month/user
Starter is $39 per user per month and includes ISO 9001, 5 GB storage, 50 AI calls per month, 10 client portal users, 2 external auditors, and email support. The site advertises 20% savings on annual billing. Professional is $79/user/month; Business is $119/user/month. All plans include a 14-day free trial; no credit card is required to start.
Free Trial
Yes
Free Version
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
Yes
iPad App
Yes
Android App
Yes
Windows
Yes
Mac
No
Linux
No
Chromebook
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Customer Support
Business Hours
Yes
Live Rep (24/7)
Yes
Online Support
Yes
Customer Support
Business Hours
No
Live Rep (24/7)
No
Online Support
No
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
Yes
In Person
No
Types of Training
Training Docs
No
Webinars
No
Live Training (Online)
No
In Person
No
Vendor Details
Company Name
SimplerQMS
Founded
2017
Country
Denmark
Website
www.simplerqms.com
Vendor Details
Company Name
ODACITY LLC
Founded
2024
Country
United States
Website
smartiso.io/
Product Features
Audit
Alerts / Notifications
Yes
Audit Planning
Yes
Compliance Management
Yes
Dashboard
Yes
Exceptions Management
No
Forms Management
Yes
Issue Management
Yes
Mobile Access
Yes
Multi-Year Planning
No
Risk Assessment
Yes
Workflow Management
Yes
CAPA
Audit Management
Yes
CAPA Planning
Yes
Change Management
Yes
Complaint Management
Yes
Incident Management
Yes
Nonconformance Tracking
Yes
Quality Control
Yes
Risk Management
Yes
Root Cause Analysis
No
Training Management
Yes
Compliance
Archiving & Retention
Yes
Artificial Intelligence (AI)
No
Audit Management
Yes
Compliance Tracking
No
Controls Testing
No
Environmental Compliance
No
FDA Compliance
Yes
HIPAA Compliance
Yes
ISO Compliance
Yes
Incident Management
No
OSHA Compliance
No
Risk Management
Yes
Sarbanes-Oxley Compliance
No
Surveys & Feedback
No
Version Control
Yes
Workflow / Process Automation
Yes
Document Control
Archiving & Retention
Yes
Automated Routing
Yes
Change Management
Yes
Compliance Management
Yes
Electronic Signature
Yes
Escalation Management
Yes
Periodic Review
Yes
Version Control
Yes
Quality Management
Audit Management
Yes
Complaint Management
Yes
Compliance Management
Yes
Corrective and Preventive Actions (CAPA)
Yes
Defect Tracking
Yes
Document Control
Yes
Equipment Management
Yes
ISO Standards Management
Yes
Maintenance Management
Yes
Risk Management
Yes
Supplier Quality Control
Yes
Training Management
Yes