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What is SmartISO?

SmartISO is a cloud-based solution crafted for compliance and quality management, specifically for organizations that manage their ISO systems in-house. It integrates multiple functions, including document control, internal audits, corrective and preventive actions (CAPA), risk management, training documentation, management reviews, supplier evaluations, and quality dashboards into a unified workspace. This integration empowers teams to effectively manage activities related to quality, environmental issues, and occupational health and safety, ensuring adherence to ISO standards throughout their workflows. Additionally, the platform features AI-enhanced tools that facilitate document drafting and analysis, enabling users to easily assess the generated materials. SmartISO is designed for quality managers, health, safety, and environmental (HSE) personnel, compliance teams, and ISO consultants working within small to medium-sized businesses. Various subscription plans are offered, varying according to standards, storage capacity, AI capabilities, and other features, while a 14-day free trial allows potential users to explore its functionalities in depth. By providing a user-friendly interface and a comprehensive set of tools, SmartISO seeks to improve the effectiveness of compliance management in a wide array of industries, ultimately helping organizations maintain their certifications with greater ease.

What is SimplerQMS?

SimplerQMS provides a cloud-centric Quality Management Software tailored specifically for the Life Science sector. This innovative platform ensures adherence to an array of regulatory standards, 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, and is fully validated under GAMP5 guidelines. The software encompasses a comprehensive suite of Life Science QMS modules, including Document Control, Change Control, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, and Quality KPIs, among additional functionalities. Moreover, SimplerQMS seamlessly integrates with Microsoft Office, enabling users to manage documents within familiar applications like Word, PowerPoint, and Excel. In summary, SimplerQMS not only streamlines operations through efficient, paperless workflows but also ensures that organizations can meet the stringent compliance mandates essential in the Life Science industry. Furthermore, its user-friendly interface and robust capabilities make it an indispensable tool for companies looking to enhance their quality management processes.

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Media

Integrations Supported

Integrations Supported

Microsoft 365
Microsoft Entra ID

API Availability

Has API

API Availability

Has API

Pricing Information

$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 Offered?

Pricing Information

$13,750/year
Everything is included, with no additional costs for implementation, modules, support, hosting, validation, etc.
Free Trial Offered?

Supported Platforms

SaaS

Supported Platforms

SaaS
Android
iPhone
iPad
Windows

Customer Service / Support

Not specified

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Not specified

Training Options

Documentation Hub
Online Training

Company Facts

Organization Name

ODACITY LLC

Date Founded

2024

Company Location

United States

Company Website

smartiso.io/

Company Facts

Organization Name

SimplerQMS

Date Founded

2017

Company Location

Denmark

Company Website

www.simplerqms.com

Categories and Features

ISO Compliance

Not specified

Categories and Features

Audit

Alerts / Notifications
Audit Planning
Compliance Management
Dashboard
Forms Management
Issue Management
Mobile Access
Risk Assessment
Workflow Management

CAPA

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

Compliance

Archiving & Retention
Audit Management
FDA Compliance
HIPAA Compliance
ISO Compliance
Risk Management
Version Control
Workflow / Process Automation

Document Control

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

ISO Compliance

Not specified

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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