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What is SimplerQMS?

SimplerQMS is a specialized electronic Quality Management System (eQMS) tailored specifically for organizations in the Life Sciences sector. Designed by industry experts, our eQMS ensures compliance with essential regulations such as FDA, ISO, and GxP by facilitating automated and audit-ready quality processes. The platform effectively centralizes and automates fundamental quality workflows within a fully validated, cloud-based system, allowing clients to minimize manual tasks, decrease errors, and maintain consistently organized records that are always inspection-ready. In contrast to standard QMS tools, SimplerQMS is pre-configured to meet the unique requirements of the Life Sciences industry, incorporating templates, workflows, and controls that align with FDA 21 CFR Part 11, 210/211, 820, EU Annex 11, ISO 13485:2016, and other relevant standards. Furthermore, clients benefit from a reliable partnership that provides extensive regulatory and quality knowledge, which includes access to audit-proven insights, advice from compliance experts, ongoing system validation, user training, round-the-clock global support, seamless implementation and data migration, along with dedicated Customer Success Experts. Our mission is to empower Life Science companies in efficiently managing quality and regulatory documentation, enabling organizations to thrive from initial growth stages to global operations while enhancing compliance, operational control, and fostering a robust quality culture. By leveraging our expertise, businesses can streamline their processes and ensure they meet the highest industry standards.

What is Adaptive Compliance Engine (ACE)?

The Adaptive Compliance Engine® (ACE®) is a versatile, workflow-driven eQMS/eDMS solution that can seamlessly adjust to various business processes, providing real-time oversight, management, and reporting for compliance, quality, and operational tasks. By utilizing ACE®, organizations can alleviate administrative burdens and enhance ROI through immediate productivity improvements, while maintaining adherence to 21 CFR Part 11 regulations. Our comprehensive software suite features: -Office 365 Integration -Inspection Management -Document Management -Risk Management -Product Lifecycle Management -Learning Management -Audit Management -Quality Events -Paperless Validation -Electronic Signatures (21 CFR Part 11 Compliant) -Endless Workflow Configurations -And numerous additional capabilities! Enable every tier of your organization with user-friendly interfaces, effortlessly locate all documents and records, and convert your data into insightful intelligence through advanced analytics, all within one unified platform. Every essential application is bundled together at a single price with ACE, eliminating the need for separate purchases. Enjoy the convenience of one software solution with countless functionalities, making it a truly invaluable asset for your business.

Media

Media

Integrations Supported

Microsoft 365
Microsoft Entra ID

Integrations Supported

Microsoft 365
SAP Access Control

API Availability

Has API

API Availability

Pricing Information

$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 Offered?

Pricing Information

We are proud to be an affordable and trusting software provider. Our pricing varies depending on numerous factors such as number of licenses, length of contract and more. We would be happy to work out a plan that best fits your needs!
Free Trial Offered?

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
Web-Based Support

Training Options

Documentation Hub
Online Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

SimplerQMS

Date Founded

2017

Company Location

Denmark

Company Website

www.simplerqms.com

Company Facts

Organization Name

PSC Software

Date Founded

1996

Company Location

United States

Company Website

pscsoftware.com/software/ace/

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

Categories and Features

Asset Tracking

Activity Tracking
Audit Trails
Barcoding / RFID
Checkout / Check-In
Depreciation Tracking
Disposal Tracking
Inventory Management
Location Tracking
QR Codes
Reservations
Service History

Audit

Alerts / Notifications
Audit Planning
Compliance Management
Dashboard
Exceptions Management
Forms Management
Issue Management
Mobile Access
Multi-Year Planning
Risk Assessment
Workflow Management

Compliance

Archiving & Retention
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
ISO Compliance
Incident Management
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation

Document Collaboration

Access Control / Permissions
Autosave
Chat / Messaging
Cloud Storage
Comments / Annotations
Edit / Change Tracking
Electronic Signature
Multiple File Formats
Pre-made Templates
Search
User Tagging
Version Control
Workflow / Approval Process

Document Control

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

Document Management

Access Controls
Archiving & Retention
Collaboration Tools
Compliance Tracking
Document Archiving
Document Assembly
Document Capture
Document Conversion
Document Delivery
Document Indexing
Document Retention
Electronic Signature
Email Management
File Recovery
File Type Conversion
Forms Management
Full Text Search
Offline Access
Optical Character Recognition
Print Management
Version Control

Document Version Control

Access Controls/Permissions
Approval Process Control
Archiving & Retention
Audit Trail
Commenting / Notes
Document Check-in / Check-out
For Engineering Documents
Revision History
Version Comparison
Version Rollback

Fixed Asset Management

Asset Budgeting
Asset Lifecycle Management
Audit Trail
Barcoding / RFID
Depreciation Management
Disposal Management
Document Management
Tax Management

Product Compliance

Not specified

Product Lifecycle Management

Change Management
Compliance Management
Cost Tracking
Design Management
Document Management
Product Data Management
Project Management
Requirements Management
Supplier Management

Product Management

Collaboration
Feedback Collection
Idea Management
Milestone Tracking
Prioritization
Product Roadmapping
Release Management
Requirements Management
Resource Management
Workflow Management

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

Risk Management

Alerts/Notifications
Auditing
Business Process Control
Compliance Management
Corrective Actions (CAPA)
Dashboard
Exceptions Management
IT Risk Management
Internal Controls Management
Legal Risk Management
Mobile Access
Operational Risk Management
Predictive Analytics
Reputation Risk Management
Response Management
Risk Assessment

Software Documentation

Access Roles / User Permissions
Automatic Documentation Generation
Collaboration Tools
Docs Web Hosting
Feedback Capture
Markdown Support
Multiple Versions Support
Version Control
Webhooks
reStructured Text Support

Training

Academic / Education
Asynchronous Learning
Blended Learning
Built-In Course Authoring
Built-in LMS
Certification Management
Corporate / Business
Learner Portal
Mobile Learning
Simulation
Synchronous Learning
eCommerce

Workflow Management

Access Controls/Permissions
Approval Process Control
Business Process Automation
Calendar Management
Compliance Tracking
Configurable Workflow
Customizable Dashboard
Document Management
Forms Management
Graphical Workflow Editor
Mobile Access
No-Code
Task Management
Third Party Integrations
Workflow Configuration

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