MasterControl Quality Excellence

4.5 (432)
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#1 Quality Management System for Life Sciences

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.


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.


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
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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

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Reviews

Overall rating

4.5 /5
(432)
Value for Money
4.2/5
Features
4.2/5
Ease of Use
4.1/5
Customer Support
4.5/5

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

Showing 5 reviews of 432
Joanne
Joanne
Overall rating
  • Industry: Biotechnology
  • Company size: 51–200 Employees
  • Used Daily for 1+ year
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support
  • Likelihood to recommend 9.0 /10

One stop shop for QMS

Reviewed on 2024/05/16

Pros

All in one and linkage between modules, job codes etc

Cons

Nomenclature is hard to understand but once using it’s fine

Shonna
Overall rating
  • Industry: Pharmaceuticals
  • Company size: 501–1,000 Employees
  • Used Daily for 2+ years
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support
  • Likelihood to recommend 6.0 /10

MasterControl QX Review

Reviewed on 2025/01/02

The Documents and Training module was a big implementation, but has been a huge timesaver from...

The Documents and Training module was a big implementation, but has been a huge timesaver from paper.

For the process module, our company has only implemented CAPAs and Management of Change (MOC). It took a long time and much assistance from MC to implement. We will be implementing future modules in the ADAPT platform once all functionality is available due to it being more easy to customize and implement.

Pros

Documents and Training is very heavily used at our organization and saves a ton of time and money. Our company also uses the process module for CAPAs and Change Control. Once it's implemented, it's easy to use and train users.

Cons

The process module is not very customizable, and the time and cost associated with implementation is very high.

Jessica
Overall rating
  • Industry: Food Production
  • Company size: 51–200 Employees
  • Used Daily for 1+ year
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support
  • Likelihood to recommend 5.0 /10

Great when it working.

Reviewed on 2025/01/02

Great concepts for quality management and traceability, but some models are poorly executed and...

Great concepts for quality management and traceability, but some models are poorly executed and there are quite a few inconvenient persistant bugs.

Pros

Good for capturing data in an auditable system for the production of food and pharmaceuticals, and life sciences.

Cons

Issues with the systems are not addressed in a timely manner and are frequent. The system has quite a few bugs, like not loading pages until you click "reload this page" in your browser.

Deirdre
Overall rating
  • Industry: Nonprofit Organization Management
  • Company size: 1,001–5,000 Employees
  • Used Daily for 2+ years
  • Review Source

Overall rating

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

Quality Assurance Excellence

Reviewed on 2025/01/07

I consider myself a life-long student of life sciences (biology) and technology. Although changes...

I consider myself a life-long student of life sciences (biology) and technology. Although changes presents challenges at times, it forces me to be flexible and to possibly learn a new skill. AI better watch out...!

Pros

OBI has been using MasterControl since 2010. It was challenging going from paper to electronic, but I have a sense of peace knowing that everyone should receive what training, access to documents, and said training, etc. I have scheduled reports and times when I audit training. Access and ability has saved me.

Cons

Lack of transparency. As a former Information Technology staff, I understand the importance of getting things (fixing issues) done now. Unfortunately, we forget to communicate or consider how certain changes may impact the organization.

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

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support
  • Likelihood to recommend 9.0 /10

Life Science

Reviewed on 2025/01/15

Overall, I enjoy the experience with MasterControl Quality Excellence.

Overall, I enjoy the experience with MasterControl Quality Excellence.

Pros

I love having a system that is digital (coming from someone who's always worked with a paper based system). The ease of routing all document types in all modules is one of my favorite features specifically for a company that has multiple sites)

Cons

Some of the pain points are the cost of licensing, not having the ability for multiple collaborators to edit the same document simultaneously, and search functionality being tough for users who aren't as familiar with document numbers/names.

Showing 5 reviews of 432 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
  • 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, Phone Support

Related categories

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