MasterControl Quality Excellence

About MasterControl Quality Excellence

MasterControl is the #1 QMS in the life sciences with more life sciences customers than any other QMS provider. For over 30 years, we’ve helped companies of all sizes bring their life-changing products to market sooner. We provide connected audit, training, document, and quality event management with data analytics and artificial intelligence (AI) functionality to help you make decisions. And with our patented software validation tools, you can ensure compliance and take advantage of every new upgrade by completing your validation in matter of hours or minutes.

Having proper procedures is an integral part of maintaining compliance. With MasterControl, you control who has rights to create, edit, or view documents and built-in audit trails show you who made what changes when. As documents are updated, old versions are automatically archived and only the newest version is available. This ensures that employees are using the right procedures and work instructions. The QMS will automatically send out training tasks to employees you indicate need to be trained on the newest version of documents.

Training is also vital to compliance. You can set up recurring training to automatically be sent out at intervals and for reminders to be sent. A simple training matrix shows you quickly which employees have completed their training on which documents. During an inspection, you can easily locate employee training records to demonstrate compliance.

In MasterControl, you configure our solution to match your quality event processes. We have best practice forms that you can use or tweak, but you can also completely design your own. A user-friendly interface lets you change quality event workflows quickly and our patented Validation on Demand (VoD) functionality keeps you compliant. When you use our validation tools, software validation is faster than ever and can be completed in a matter of minutes.

Our QMS also provides analytics tools to help you connect and use all the data stored in MasterControl. MasterControl Insights lets you visually explore your data with dashboards and reports. We also have AI components in Insights to help you improve quality in your company.

Pricing starting from:

US$25,000.00/year

  • Free Version
  • Free Trial
  • Subscription

Key benefits of MasterControl Quality Excellence

Automates the document creation and approval process, including routing, scheduling, escalation, tracking, follow-up, review, and approval.

Connects all quality processes and documentation in a centralized location.

Puts you in an audit-ready state so you can pass an audit or inspection at any time.

Automates compliance to let your employees focus on innovation.

Stores all documents in a centralized, searchable location with automated version control.

Automates training so you spend less time tracking it and sending follow-up emails.

Connects all quality event processes and ensures nothing falls through the cracks.

Gives you complete access to your quality data so you can make better decisions faster.

Includes patented validation tools that cut initial validation to an average of 20 hours and change control for an upgrade to an average of 45 minutes.

Typical Customers

  • Freelancers
  • Small Businesses (2-50)
  • Mid-size Companies (51-500)
  • Large enterprises (500 and more)

Deployment

  • Cloud-based
  • On-premise

Markets

Australia, Austria, Belgium, Canada, China and 27 others

Supported Languages

English

Pricing starting from:

US$25,000.00/year

  • Free Version
  • Free Trial
  • Subscription

Images

MasterControl Quality Excellence Software - QMS Homepage
MasterControl Quality Excellence Software - Quality Event Related Tasks
MasterControl Quality Excellence Software - Easily Build Quality Event Workflows
MasterControl Quality Excellence Software - Analyze Quality Data
MasterControl Quality Excellence Software - Automate Training
MasterControl Quality Excellence Software - Manage Quality Documents
View 7 more
MasterControl Quality Excellence video
MasterControl Quality Excellence Software - QMS Homepage
MasterControl Quality Excellence Software - Quality Event Related Tasks
MasterControl Quality Excellence Software - Easily Build Quality Event Workflows
MasterControl Quality Excellence Software - Analyze Quality Data
MasterControl Quality Excellence Software - Automate Training
MasterControl Quality Excellence Software - Manage Quality Documents

Features

Total features of MasterControl Quality Excellence: 92

  • Access Controls/Permissions
  • Activity Dashboard
  • Activity Tracking
  • Alerts/Escalation
  • Alerts/Notifications
  • Approval Process Control
  • Archiving & Retention
  • Audit Management
  • Audit Trail
  • Automated Scheduling
  • Bills of Material
  • Business Process Control
  • Change Management Software
  • Commenting/Notes
  • Communications Management
  • Complaint Management Software
  • Compliance Management
  • Compliance Tracking
  • Corrective and Preventive Actions (CAPA)
  • Cost Tracking
  • Customer Complaint Tracking
  • Customizable Forms
  • Customizable Reports
  • Customizable Templates
  • Dashboard Software
  • Data Import/Export
  • Defect Tracking
  • Design Management
  • Digital Signature Software
  • Document Automation
  • Document Check-in/Check-out
  • Document Coding & Control
  • Document Management Software
  • Document Review
  • Document Storage
  • Document Templates
  • Electronic Signature
  • Email Alerts
  • Environmental Compliance
  • Equipment Management
  • FDA Compliance
  • Feedback Management
  • For Engineering Documents
  • Forms Management
  • Full Text Search
  • ISO Compliance
  • ISO Standards Management
  • Incident Management Software
  • Internal Controls Management
  • Inventory Management Software
  • Issue Management
  • Issue Tracking Software
  • Maintenance Management Software
  • Mobile Access
  • Multi-Location
  • Nonconformance Tracking
  • Operational Risk Management
  • Order Management Software
  • Predictive Analytics Software
  • Prioritization
  • Product Data Management Software
  • Production Scheduling Software
  • Project Management Software
  • Quality Assurance
  • Quality Control
  • Quality Management Software
  • Real-Time Data
  • Real-Time Reporting
  • Real-Time Updates
  • Reporting & Statistics
  • Reporting/Analytics
  • Response Management
  • Revision History
  • Risk Assessment
  • Risk Management Software
  • Risk Reporting
  • Risk Scoring
  • Root Cause Analysis
  • Routing
  • Safety Management Software
  • Scheduling Software
  • Status Tracking
  • Supplier Management
  • Supplier Quality Control
  • Task Management Software
  • Third-Party Integrations
  • Traceability
  • Training Management
  • Version Comparison
  • Version Control
  • Version Rollback
  • Workflow Management Software

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Reviews

Overall rating

4.5 /5
(425)
Value for Money
4.2/5
Features
4.2/5
Ease of Use
4.1/5
Customer Support Software
4.5/5

Already have MasterControl Quality Excellence?

Software buyers need your help! Product reviews help the rest of us make great decisions.

Showing 5 reviews of 425
Nicholas
Nicholas
Overall rating
  • Industry: Medical Devices
  • Company size: 11–50 Employees
  • Used Daily for 2+ years
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 10.0 /10

Excellent eQMS system

Reviewed on 2023-10-17

The overall experience has been very good.

The overall experience has been very good.

Pros

It is much easier to manage the documentation. Paper records easily get lost.

Cons

The least appealing part is the cost. The product is quite expensive but we believe it is worth it.

Katja
Overall rating
  • Industry: Nanotechnology
  • Company size: 1,001–5,000 Employees
  • Used Daily for 2+ years
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 8.0 /10

MasterControl electronic Quality Management System

Reviewed on 2024-05-15

MasterControl has a great amount of functionality to offer already and continues to develop its...

MasterControl has a great amount of functionality to offer already and continues to develop its products, with ambitious and exciting roadmaps.

Pros

Moving our document change review and deviation processes from paper based into MasterControl has been an absolute game changer - the risk of losing records has reduced dramatically. We now have much greater visibility at which step in a process a document change is and who is involved in deviations.

Cons

Some of the user functionality can be not entirely intuitive, making it slightly more difficult to navigate for users who use the system only occasionally.

Hannah
Overall rating
  • Industry: Biotechnology
  • Company size: 501–1,000 Employees
  • Used Daily for 1+ year
  • Review Source

Overall rating

  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 4.0 /10

Better than bespoke but not excellent yet

Reviewed on 2024-05-15

The user interface is not user friendly but the product works as intended

The user interface is not user friendly but the product works as intended

Pros

It is easier to maintain than a bespoke QMS

Cons

The lack of configurability pre AQEM which we haven’t implemented yet

Alternatives Considered

TrackWise
Sophie
Overall rating
  • Industry: Pharmaceuticals
  • Company size: 1,001–5,000 Employees
  • Used Weekly for 2+ years
  • Review Source

Overall rating

  • Ease of Use
  • Likelihood to recommend 10.0 /10

Using MX Production in a GMP Pharmaceutical Manufacturing setting.

Reviewed on 2024-04-30

My experience is using MX to create electronic batch manufacturing records (eBMRs) to suit our...

My experience is using MX to create electronic batch manufacturing records (eBMRs) to suit our process prior to manufacturing, throughout manufacture and then reviewing the executed eBMR after use. This has been a hugely positive one and i'm excited to see the further improvements we can make with MX.

Pros

The system is very easy to access and use. It allows for an easy audit trail of users and during the construction of templates edits can easily be made and approved by several users before release. During manufacture the ability to force steps to be filled in by an operator before moving on is huge. Reviews are so much quicker than before and we have beat many targets due to this.

Cons

In my role there aren't currently any aspects of MX that cause an issue.

Lynn
Overall rating
  • Industry: Medical Devices
  • Company size: 10,000+ Employees
  • Used Daily for 2+ years
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 8.0 /10

User experience

Reviewed on 2024-05-16

A mostly positive experience with the system, with some minor improvement it could be exactly what...

A mostly positive experience with the system, with some minor improvement it could be exactly what we need to have to maintain our processes.

Pros

Having everything in one place makes it easier to manage the document management tasks

Cons

Sometimes there are parts of the system that are unable to be edited/updates and this can limit how we schedule our tasks

Showing 5 reviews of 425 Read all reviews

MasterControl Quality Excellence FAQs

Below are some frequently asked questions for MasterControl Quality Excellence.

MasterControl Quality Excellence offers the following pricing plans:

  • Starting from: US$25,000.00/year View Pricing Plans
  • Pricing model: Subscription
  • Free Trial: Not Available

Contact MasterControl for detailed pricing information.

MasterControl Quality Excellence has the following typical customers:

51–200, 201–500, 501–1,000, 1,001–5,000

MasterControl Quality Excellence supports the following languages:

English

MasterControl Quality Excellence supports the following devices:

Android (Mobile), iPhone (Mobile), iPad (Mobile)

MasterControl Quality Excellence integrates with the following applications:

Microsoft Excel, Microsoft PowerPoint, Microsoft Word

MasterControl Quality Excellence offers the following support options:

Email/Help Desk, FAQs/Forum, Knowledge Base Software, Phone Support

Related categories

See all software categories found for MasterControl Quality Excellence.