SmartISOODACITY LLC
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Related Products
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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.
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About
SmartISO is a cloud-based compliance and quality management platform for organizations managing ISO systems internally. It brings document control, internal audits, corrective and preventive actions (CAPA), risk management, training records, management review, supplier evaluation, and quality dashboards into one workspace. Teams can coordinate quality, environmental, and occupational health and safety activities, with workflows aligned to ISO requirements. AI-assisted features support document drafting and analysis, with generated content available for user review. SmartISO is intended for quality and HSE managers, compliance teams, and ISO consultants at small and mid-sized organizations. Plans vary by standards, storage, AI allowances, and other included features; a 14-day free trial is available.
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Platforms Supported
Windows
Supported
Mac
Not Supported
Linux
Not Supported
Cloud
Supported
On-Premises
Not Supported
iPhone
Supported
iPad
Supported
Android
Supported
Chromebook
Not Supported
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Platforms Supported
Windows
Not Supported
Mac
Not Supported
Linux
Not Supported
Cloud
Supported
On-Premises
Not Supported
iPhone
Not Supported
iPad
Not Supported
Android
Not Supported
Chromebook
Not Supported
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Audience
Companies in the Life Science industries - Medical Device, Pharmaceutical, Biotechnology, Laboratory, and others.
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Audience
Quality managers, HSE managers, compliance officers and ISO consultants at small and mid-sized organizations
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Support
Phone Support
Supported
24/7 Live Support
Supported
Online
Supported
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Support
Phone Support
Not Supported
24/7 Live Support
Not Supported
Online
Not Supported
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API
Offers API
Supported
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API
Offers API
Supported
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Screenshots and Videos |
Screenshots and VideosNo images available
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Pricing
$13,750/year
Everything is included, with no additional costs for implementation, modules, support, hosting, validation, etc.
Free Version
Not Supported
Free Trial
Supported
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Pricing
$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 Version
Not Supported
Free Trial
Supported
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Reviews/
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Reviews/
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Pros & Cons from Real UsersPros
Cons
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Training
Documentation
Supported
Webinars
Not Supported
Live Online
Supported
In Person
Not Supported
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Training
Documentation
Not Supported
Webinars
Not Supported
Live Online
Not Supported
In Person
Not Supported
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Company InformationSimplerQMS
Founded: 2017
Denmark
www.simplerqms.com
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Company InformationODACITY LLC
Founded: 2024
United States
smartiso.io/
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Alternatives |
Alternatives |
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Categories |
Categories |
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Audit Features
Alerts / Notifications
Supported
Audit Planning
Supported
Compliance Management
Supported
Dashboard
Supported
Exceptions Management
Not Supported
Forms Management
Supported
Issue Management
Supported
Mobile Access
Supported
Multi-Year Planning
Not Supported
Risk Assessment
Supported
Workflow Management
Supported
CAPA Features
Audit Management
Supported
CAPA Planning
Supported
Change Management
Supported
Complaint Management
Supported
Incident Management
Supported
Nonconformance Tracking
Supported
Quality Control
Supported
Risk Management
Supported
Root Cause Analysis
Not Supported
Training Management
Supported
Compliance Features
Archiving & Retention
Supported
Artificial Intelligence (AI)
Not Supported
Audit Management
Supported
Compliance Tracking
Not Supported
Controls Testing
Not Supported
Environmental Compliance
Not Supported
FDA Compliance
Supported
HIPAA Compliance
Supported
Incident Management
Not Supported
ISO Compliance
Supported
OSHA Compliance
Not Supported
Risk Management
Supported
Sarbanes-Oxley Compliance
Not Supported
Surveys & Feedback
Not Supported
Version Control
Supported
Workflow / Process Automation
Supported
Document Control Features
Archiving & Retention
Supported
Automated Routing
Supported
Change Management
Supported
Compliance Management
Supported
Electronic Signature
Supported
Escalation Management
Supported
Periodic Review
Supported
Version Control
Supported
Quality Management Features
Audit Management
Supported
Complaint Management
Supported
Compliance Management
Supported
Corrective and Preventive Actions (CAPA)
Supported
Defect Tracking
Supported
Document Control
Supported
Equipment Management
Supported
ISO Standards Management
Supported
Maintenance Management
Supported
Risk Management
Supported
Supplier Quality Control
Supported
Training Management
Supported
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Integrations
Microsoft 365
Not Supported
Microsoft Entra ID
Not Supported
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