SimplerQMS Reviews

SimplerQMS

3.0 out of 5 stars

Average Ratings 0 Ratings

Total 0 out of 5 stars
ease 0 out of 5 stars
features 0 out of 5 stars
design 0 out of 5 stars
support 0 out of 5 stars

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Average Ratings 2 Ratings

Total 3 out of 5 stars
ease 3 out of 5 stars
features 2.5 out of 5 stars
design 2.5 out of 5 stars
support 3.5 out of 5 stars

Description

Mitigate losses and minimize risk occurrences through proactive risk visibility. Foster a contemporary and cohesive risk management strategy that leverages real-time, consolidated risk intelligence to assess their influence on business goals and investments. Safeguard your brand’s reputation, reduce compliance costs, and cultivate trust among regulators and board members. Keep abreast of changing regulatory demands by actively managing compliance risks, policies, case evaluations, and control assessments. Promote risk-conscious decision-making and enhance business performance by aligning audits with strategic priorities, organizational goals, and associated risks. Deliver prompt insights on potential risks while bolstering collaboration among different departments. Decrease vulnerability to third-party risks and enhance sourcing choices. Avert incidents related to third-party risks through continuous monitoring of compliance and performance. Streamline and simplify the entire lifecycle of third-party risk management while ensuring that all stakeholders are informed and engaged throughout the process.

Description

SimplerQMS is an expert-driven electronic Quality Management System (eQMS) purpose-built for Life Science organizations. Our eQMS is designed by professionals with deep industry experience and supports compliance with FDA, ISO, and GxP requirements through automated, audit-ready quality processes. The platform centralizes and automates core quality workflows within a cloud-based, fully validated system. Customers benefit from reduced manual work, fewer errors, and consistently organized, inspection-ready records. Unlike generic QMS tools, SimplerQMS comes pre-configured for Life Science needs, with built-in templates, workflows, and controls aligned with FDA 21 CFR Part 11, 210/211, 820, EU Annex 11, ISO 13485:2016, and other applicable standards. Beyond software, customers gain a trusted partner backed by deep regulatory and quality expertise. This includes: • Audit-proven insights • Guidance from compliance specialists • Continuous system validation • User training • 24/7 global support • Smooth implementation and data migration • Dedicated Customer Success Experts With a mission to help Life Science companies manage quality and regulatory documentation efficiently, SimplerQMS supports organizations from early-stage growth to global scale to strengthen compliance, operational control, and quality culture.

API Access

Has API No 

API Access

Has API Yes 

Screenshots View All

Screenshots View All

Integrations

Boardwalktech Yes 
Microsoft 365 No 
Microsoft Entra ID No 
Qualys WAS Yes 

Integrations

Boardwalktech No 
Microsoft 365 Yes 
Microsoft Entra ID Yes 
Qualys WAS No 

Pricing Details

No price information available.
Free Trial Yes 
Free Version No 

Pricing Details

$17,500 / year
We offer subscription-based pricing with everything you need – integrated QMS modules, full implementation and onboarding, validation, user training, cloud hosting, QMS templates, data migration, and ongoing support. No hidden costs.
Free Trial Yes 
Free Version 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 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App Yes 
iPad App Yes 
Android App Yes 
Windows Yes 
Mac Yes 
Linux No 
Chromebook No 

Customer Support

Business Hours Yes 
Live Rep (24/7) No 
Online Support Yes 

Customer Support

Business Hours Yes 
Live Rep (24/7) Yes 
Online Support Yes 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) Yes 
In Person No 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) Yes 
In Person No 

Vendor Details

Company Name

MetricStream

Founded

1999

Country

United States

Website

www.metricstream.com

Vendor Details

Company Name

SimplerQMS

Founded

2017

Country

Denmark

Website

www.simplerqms.com

Product Features

Audit

Alerts / Notifications No 
Audit Planning No 
Compliance Management No 
Dashboard No 
Exceptions Management No 
Forms Management No 
Issue Management No 
Mobile Access No 
Multi-Year Planning No 
Risk Assessment No 
Workflow Management No 

Business Continuity

Backup Log No 
Backup Scheduling No 
Compression No 
Continuous Backup No 
Encryption No 
Incremental Backup No 
Local Server Options No 
Multiple System Support No 
Remote Server Options No 
Secure Data Storage No 
Web Access / Restoration No 

CAPA

Audit Management No 
CAPA Planning No 
Change Management No 
Complaint Management No 
Incident Management No 
Nonconformance Tracking No 
Quality Control No 
Risk Management No 
Root Cause Analysis No 
Training Management No 

Compliance

Archiving & Retention No 
Artificial Intelligence (AI) No 
Audit Management No 
Compliance Tracking No 
Controls Testing No 
Environmental Compliance No 
FDA Compliance No 
HIPAA Compliance No 
ISO Compliance No 
Incident Management No 
OSHA Compliance No 
Risk Management No 
Sarbanes-Oxley Compliance No 
Surveys & Feedback No 
Version Control No 
Workflow / Process Automation No 

Disaster Recovery

Administration Policies No 
Bare-Metal Recovery No 
Encryption No 
Failover Testing No 
Flexible Data Capture No 
Multi-Platform Support No 
Multiple Data Type Support No 
Offline Storage No 

Document Management

Access Controls No 
Archiving & Retention No 
Collaboration Tools No 
Compliance Tracking No 
Document Archiving No 
Document Assembly No 
Document Capture No 
Document Conversion No 
Document Delivery No 
Document Indexing No 
Document Retention No 
Electronic Signature No 
Email Management No 
File Recovery No 
File Type Conversion No 
Forms Management No 
Full Text Search No 
Offline Access No 
Optical Character Recognition No 
Print Management No 
Version Control No 

GDPR Compliance

Access Control No 
Consent Management No 
Data Mapping No 
Incident Management No 
PIA / DPIA No 
Policy Management No 
Risk Management No 
Sensitive Data Identification No 

GRC

Auditing No 
Disaster Recovery No 
Environmental Compliance No 
IT Risk Management No 
Incident Management No 
Internal Controls Management No 
Operational Risk Management No 
Policy Management No 

Incident Management

Audit Trail No 
Corrective Actions (CAPA) No 
Disaster Recovery No 
IT Incident Management No 
Incident Reporting No 
OSHA Compliance No 
Root-Cause Diagnosis No 
Safety Management No 
Task Management No 
Ticket Management No 

Integrated Risk Management

Audit Management No 
Compliance Management No 
Dashboard No 
Disaster Recovery No 
IT Risk Management No 
Incident Management No 
Operational Risk Management No 
Risk Assessment No 
Safety Management No 
Vendor Management No 

PCI Compliance

Access Control No 
Compliance Reporting No 
Exceptions Management No 
File Integrity Monitoring No 
Intrusion Detection System No 
Log Management No 
PCI Assessment No 
Patch Management No 
Policy Management No 

Policy Management

Approval Process Control No 
Attestation No 
Audit Trails No 
Policy Creation No 
Policy Library No 
Policy Metadata Management No 
Policy Training No 
Reporting / Analytics No 
Version Control No 
Workflow Management No 

Risk Management

Alerts/Notifications No 
Auditing Yes 
Business Process Control Yes 
Compliance Management Yes 
Corrective Actions (CAPA) Yes 
Dashboard Yes 
Exceptions Management No 
IT Risk Management No 
Internal Controls Management Yes 
Legal Risk Management No 
Mobile Access No 
Operational Risk Management No 
Predictive Analytics No 
Reputation Risk Management No 
Response Management Yes 
Risk Assessment Yes 

Vulnerability Management

Asset Discovery No 
Asset Tagging No 
Network Scanning No 
Patch Management No 
Policy Management No 
Prioritization No 
Risk Management No 
Vulnerability Assessment No 
Web Scanning No 

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 

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