Average Ratings 1 Rating

Total
ease
features
design
support

Average Ratings 0 Ratings

Total
ease
features
design
support

No User Reviews. Be the first to provide a review:

Write a Review

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

Screenshots View All

No images available

Integrations

Microsoft 365 Yes 
Microsoft Entra ID Yes 

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 

Product Features

Alternatives

QEdge Reviews

QEdge

Sarjen Systems Pvt Ltd

Alternatives

Dot Compliance QMS Reviews

Dot Compliance QMS

QMS for Life Sciences
isoTracker Quality Management Reviews

isoTracker Quality Management

isoTracker Solutions Ltd
Dot Compliance QMS Reviews

Dot Compliance QMS

QMS for Life Sciences
QT9 QMS Reviews

QT9 QMS

QT9 Software
QualityPro by TecWork Reviews

QualityPro by TecWork

TecWork Global Business Solutions Pvt. Ltd.
SoftExpert EQM Reviews

SoftExpert EQM

SoftExpert