Average Ratings 2 Ratings

Total
ease
features
design
support

Average Ratings 1 Rating

Total
ease
features
design
support

Description

It can seem like a never-ending series of tradeoffs to bring breakthrough products to market within highly regulated industries. MasterControl's GxP software simplifies workflows, so you don't have to compromise quality for cost or innovation with regulation. Complete and connected meets flexible and fast. MasterControl Quality Excellence transforms quality data and processes to a competitive edge. Modern software is the first step in modernizing your manufacturing operations. MasterControl Manufacturing Excellence, from work orders to production records (EBR/eDHR), to logbooks and work instructions, is the easiest way to digitalize manufacturing.

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.

API Access

Has API Yes 

API Access

Has API Yes 

Screenshots View All

Screenshots View All

Integrations

Inspired eLearning HR & Compliance Yes 
Microsoft 365 No 
Microsoft Entra ID No 
Microsoft Excel Yes 
Microsoft PowerPoint Yes 
Microsoft Word Yes 
Res_Q Yes 
SAP Business ByDesign Yes 
Showpad Coach Yes 
VIPRE Security Awareness Yes 

Integrations

Inspired eLearning HR & Compliance No 
Microsoft 365 Yes 
Microsoft Entra ID Yes 
Microsoft Excel No 
Microsoft PowerPoint No 
Microsoft Word No 
Res_Q No 
SAP Business ByDesign No 
Showpad Coach No 
VIPRE Security Awareness No 

Pricing Details

$25,000 / 1st year
25k for first year with a 5 license minimum
Free Trial No 
Free Version 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 

Deployment

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

Customer Support

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

Customer Support

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

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person Yes 

Types of Training

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

Vendor Details

Company Name

MasterControl

Founded

1994

Country

United States

Website

www.mastercontrol.com

Vendor Details

Company Name

SimplerQMS

Founded

2017

Country

Denmark

Website

www.simplerqms.com

Product Features

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 

Change Management

Approval Workflow Yes 
Audit Trail Yes 
Automated Notifications No 
Change Calendar No 
Change Planning Yes 
Compliance Management Yes 
Prioritization No 
Release Management Yes 
Task Management Yes 
Tracking & Reporting No 
Training Management Yes 

Complaint Management

Case Management No 
Complaint Classification Yes 
Corrective Actions (CAPA) Yes 
Customer Complaint Tracking Yes 
Feedback Management Yes 
Forms Management Yes 
Issue Tracking Yes 
Quality Assurance Management Yes 
Routing Yes 
Self Service Portal No 
Social Media Monitoring No 
Survey Management No 

Compliance

Archiving & Retention Yes 
Artificial Intelligence (AI) No 
Audit Management Yes 
Compliance Tracking Yes 
Controls Testing No 
Environmental Compliance Yes 
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 

Document Management

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

Document Version Control

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

EHS Management

Audit Management No 
Corrective / Preventive Actions No 
Environmental Management No 
Environmental Risk Assessment No 
Forms Management No 
Incident Management No 
Industrial Safety Management No 
Injury Reporting No 
Inspection Management No 
MSDS No 
OSHA Recordkeeping No 
Occupational Health Management No 
Safety Risk Assessment No 
Training Management No 
Waste Management No 

Manufacturing Execution

Document Management No 
Forecasting No 
Quality Control No 
Quote Management No 
Resource Management No 
Supplier Management No 
Supply Chain Management No 
Traceability No 

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 

Risk Management

Alerts/Notifications Yes 
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 Yes 
Operational Risk Management Yes 
Predictive Analytics Yes 
Reputation Risk Management No 
Response Management Yes 
Risk Assessment Yes 

Safety Management

Audit Management No 
Corrective / Preventive Actions No 
Incident Management No 
Injury Reporting No 
Inspection Management No 
OSHA Recordkeeping No 
Safety Risk Assessment No 
Training Management No 

SPC

Corrective Actions (CAPA) Yes 
Data Entry No 
Data Linking No 
Data Management No 
Excel Loader No 
Job Management No 
OPC Data Collection No 
Performance Metrics No 
Point-of-Production Analysis No 
Real Time Data Collection No 
Regulatory Compliance Yes 

Work Instructions

Branding & Style Sheets No 
Content Management System No 
Drag and Drop No 
Dynamic Tags No 
Employee Feedback No 
Guide Approval Workflows No 
Media Editor No 
Multi-Brand Publishing No 
Rich Text Editor No 
SSO (SAML) No 
Translations No 
User Management No 
Version Control Yes 

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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