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MasterControl Quality Excellence Logo

Quality Management—Simplified with Life Sciences-Specialized

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MasterControl Quality Excellence - 2026 Pricing, Features, Reviews & Alternatives

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All user reviews are verified by in-house moderators and provider data by our software research team.  Learn more

Last updated: September 2026

MasterControl Quality Excellence overview

Verified reviewer profile picture

Based on 540 verified user reviews

What is MasterControl Quality Excellence?

MasterControl Quality Excellence is a document management solution with key features that include document storage, electronic signature, version control, access controls/permissions, and corrective and preventive actions (CAPA), and more.

Who uses MasterControl Quality Excellence?

By industry, MasterControl Quality Excellence reviewers are most commonly professionals in pharmaceuticals (33%). The most frequent use case cited by reviewers is quality management (72%).

Starting price

25000 /
per year
view pricing plans

Pros & Cons

Compliance and Validation

Integrations

Ease of Use

Form Customization

Bugs and Issues

Complex and non-intuitive navigation

MasterControl Quality Excellence’s user interface

Ease of use rating:

MasterControl Quality Excellence reviews

Overall rating

4.5

/5

540

Positive reviews

68

%

Rating breakdown
  • Value for money
  • Ease of use
  • Features
  • Customer support
  • Likelihood to recommend0.68/10
Rating distribution

5

4

3

2

1

297

206

35

2

0

Pros
“It is a reliable and mature solution for managing quality systems in regulated environments and it supports digital transformation initiatives effectively. While there are areas that could be improved in terms of usability and flexibility, the platform provides strong compliance support and helps standardize quality processes across different functions and sites.”
Verified reviewer profile picture

Simone B.

Quality compliance specialist

“MasterControl Quality Excellence is a solid and comprehensive eQMS platform, particularly suitable for highly regulated industries such as pharmaceuticals and medical devices.”
Verified reviewer profile picture

Simone B.

Quality compliance specialist

“This gives our company the ability to keep track of documents, training, investigations, and other forms and records to ensure quality at our organization.”
MA

Megin A.

Qa specialist

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.”
JA

Johana A.

Jr MasterControl Sys Admin

“The performance on "on prem" version, pdf publishing time and constant issues with pdf not beeing generated, issues with custom forms created by MC.”
MM

Michal M.

IT QMS Software Administrator

“The adapt platform has code updates quite often which seems to impact our systems with the introduction of bugs and defects on a regular basis.”
LD

Laura D.

Manager, QA

Who uses MasterControl Quality Excellence?

Based on 540 verified user reviews.

Company size

Small Businesses

Midsize Businesses

Enterprises

Top industries

Pharmaceuticals
Biotechnology
Medical Devices
Hospital & Health Care
Others

Use cases

Quality Management
Document Management
Document Control
Corrective and Preventive Action
Document Version Control

MasterControl Quality Excellence's key features

GetApp's analysis of 118 verified user reviews collected between January 2022 and June 2024 identifies MasterControl Quality Excellence's most critical features and summarizes user sentiment about those features.

Document storage

Reviewers appreciate MasterControl Quality Excellence's document storage capabilities, highlighting its compliance with 21 CFR Part 11 and ISO 13485. They find it easy to retrieve any document version, which is important for audits and regulatory requirements. Users report that the system simplifies organization with custom fields and taxonomy folders, making documents easily accessible. They also value the secure cloud storage and the ability to manage the entire document lifecycle, ensuring traceability and compliance. Of the 56 MasterControl Quality Excellence users who gave detailed accounts of their use of Document Storage, 100% rated this feature as important or highly important.


Electronic signature

Reviewers indicate that MasterControl Quality Excellence's electronic signature feature ensures compliance with 21 CFR Part 11 and EU Annexes. They find it user-friendly and appreciate the audit trail it provides, which enhances traceability and accountability. Users report that it speeds up the approval process and reduces administrative work. They also value the ability to sign documents remotely, which supports efficient workflows and regulatory compliance. Of the 41 MasterControl Quality Excellence users who gave detailed accounts of their use of Electronic Signature, 98% rated this feature as important or highly important.


Archiving & retention

Users report that MasterControl Quality Excellence's archiving and retention capabilities help maintain compliance with ISO 13485 and FDA regulations. They appreciate the customizable archiving options and the ease of retrieving historical documents. Reviewers indicate that the system allows for setting future expiration dates and defining document lifecycles, which supports regulatory compliance and efficient document management. They also value the ability to keep archived documents accessible yet hidden when necessary. Of the 27 MasterControl Quality Excellence users who gave detailed accounts of their use of Archiving & Retention, 96% rated this feature as important or highly important.


Version control

Reviewers highlight MasterControl Quality Excellence's version control capabilities, noting its flexibility in tracking and recalling document versions and revisions. They appreciate the controlled release process, which ensures only the most up-to-date documents are used. Users report that this capability is critical for regulated environments, as it maintains compliance and prevents the use of outdated documents. They also value the automatic versioning and detailed audit trails. Of the 24 MasterControl Quality Excellence users who gave detailed accounts of their use of Version Control, 96% rated this feature as important or highly important.


Document management

Users report that MasterControl Quality Excellence's document management capabilities are essential for maintaining compliance and streamlining workflows. They appreciate the automated workflows, vaults, and lifecycles, which make document management more efficient. Reviewers indicate that the system supports collaboration across departments and ensures that current document versions are easily accessible. They also value the ability to customize access permissions and the integration with training modules. Of the 67 MasterControl Quality Excellence users who gave detailed accounts of their use of Document Management, 96% rated this feature as important or highly important.

See related user reviews

“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.”
JA

Johana A.

Jr MasterControl Sys Admin

“The creating, collaborating and routing documents are very straight forward and when there are issues, it is very easy to submit tickets and get answers with a quick turn around.”
PC

Patricia C.

Associate Quality Manager

“Despite the cons, MasterControl is essential for our document and quality event management.”
SS

Samuel S.

QA Compliance Specialist

“It's a well-rounded, multi-faceted way to keep documents on hand and organized for multiple purposes across many departments.”
JW

Jessica W.

Document Admin


Access controls/permissions

Reviewers find MasterControl Quality Excellence's access controls and permissions capabilities valuable for regulatory compliance. They appreciate the ability to customize access based on roles and job functions, ensuring that only authorized users can access specific documents. Users report that the system is easy to configure and maintain, though some note the complexity of managing numerous roles and permissions. They also highlight the importance of data security and the ability to control document access effectively. Of the 54 MasterControl Quality Excellence users who gave detailed accounts of their use of Access Controls/Permissions, 94% rated this feature as important or highly important.


All MasterControl Quality Excellence features

Features rating:

Activity dashboard
Activity tracking
Alerts/Escalation
Alerts/Notifications
Approval process control
Audit management
Audit planning
Audit trail
Automated scheduling
Bills of material
Business process control
Change management
Collaboration tools
Commenting/Notes
Communications management
Complaint management
Compliance management
Compliance tracking
Corrective and preventive actions (capa)
Cost tracking
Customer complaint tracking
Customizable forms
Customizable reports
Customizable templates
Dashboard
Data import/export
Data security
Data visualization
Defect tracking
Design management
Digital signature
Document automation
Document capture
Document check-in/check-out
Document coding & control
Document generation
Document review
Document templates
EDI
Email alerts
Environmental compliance
Equipment management
FDA compliance
Feedback management
File sharing
For Engineering Documents
Forms management
Full text search
Incident management
Internal controls management
Inventory management
ISO compliance
ISO standards management
Issue management
Issue tracking
Maintenance management
Mobile access
Monitoring
Multi-Location
Nonconformance tracking
Operational risk management
Order management
Predictive analytics
Prioritization
Product data management
Production scheduling
Project management
Quality assurance
Quality control
Quality management
Real-Time data
Real-Time reporting
Real-Time updates
Reminders
Reporting/Analytics
Reporting & statistics
Response management
Revision history
Risk analysis
Risk assessment
Risk management
Risk reporting
Risk scoring
Root cause analysis
Routing
Safety management
Scheduling
Search/Filter
Secure data storage
Status tracking
Supplier management
Supplier quality control
Task management
Third-Party integrations
Traceability
Training management
Version comparison
Version rollback
Workflow management

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MasterControl Quality Excellence pricing

Value for money rating:

Pricing plans

Pricing details:

Free plan
Free trial
Subscription

Basic

25,000

Per year

Features included:

  • Document Management
  • Change Control
  • Analytics
  • Business Intelligence

Standard

Empty state illustration for "No pricing info"

No pricing info

Features included:

  • Training Management
  • Exams

Complete

Empty state illustration for "No pricing info"

No pricing info

Features included:

  • Event Management
  • Risk Management
  • Audit Management
  • Supplier Management

User opinions about MasterControl Quality Excellence price and value

Value for money rating:

To see what individual users think of MasterControl Quality Excellence's price and value, check out the review snippets below.

“It is a reliable and mature solution for managing quality systems in regulated environments and it supports digital transformation initiatives effectively. While there are areas that could be improved in terms of usability and flexibility, the platform provides strong compliance support and helps standardize quality processes across different functions and sites.”
Verified reviewer profile picture

Simone B.

Quality compliance specialist

“MasterControl Quality Excellence is a solid and comprehensive eQMS platform, particularly suitable for highly regulated industries such as pharmaceuticals and medical devices.”
Verified reviewer profile picture

Simone B.

Quality compliance specialist

MasterControl Quality Excellence integrations (13)

Integrations rated by users

We looked at 540 user reviews to identify which products are mentioned as MasterControl Quality Excellence integrations and how users feel about them.

Integration rating: 4.0 (18)

for template generation

BR

Brooke R.

Paralegal

Integration rating: 4.4 (11)

Integration rating: 3.7 (4)

Integration rating: 3.5 (4)

Snowflake logo
Snowflake

Integration rating: 3.5 (4)

Single view of the customer.

RR

Robert R.

Principle Product Manager

Integration rating: 4.3 (3)

MasterControl Quality Excellence customer support

What do users say about MasterControl Quality Excellence customer support?

Customer support rating:

We analyzed verified user reviews to identify positive and negative aspects of MasterControl Quality Excellence customer support.

A significant portion of users highlight the support team's responsiveness and effectiveness in resolving issues quickly.

Multiple users appreciate always having a live person to speak to and finding support easy to reach when needed.

A number of users mention the support team's helpfulness during implementation and ongoing system updates.

Widely noted by reviewers, customer support is knowledgeable, proactive, and values user feedback and suggestions.

Support options

Knowledge base
Email/help desk
Phone support
Faqs/forum
Chat

Training options

Videos
Webinars
Documentation
In person
Live online

To see what individual users say about MasterControl Quality Excellence's customer support, check out the review snippets below.

“The customer support team really tries to work with you to solve issues.”

Verified reviewer profile picture

Tamara P.

QA

“The support team has been incredible in both my transition, as well as our transition from 2018.3-2023.3.”

MJ

Meredith J.

Assistant Director of PI & Regulatory Compliance

“We found a lot of bugs and their customer service was lacking for the overall cost.”

CC

Christina C.

QA

MasterControl Quality Excellence FAQs

Q. Who are the typical users of MasterControl Quality Excellence?

MasterControl Quality Excellence has the following typical customers:
Small Business, Large Enterprises, Mid-size Business

These products have better value for money


Q. What is MasterControl Quality Excellence used for?

Quality Management—Simplified with Life Sciences-Specialized AI MasterControl Quality Excellence (Qx) is the #1 Quality Management System (QMS) in life sciences. Built on an AI-driven platform, it enables life-sciences companies to enable flexible quality event management, simplified document management, and automated training management—that all work seamlessly together to close the loop on quality. Qx is, trusted by more than 1,300 pharmaceutical, biotech, and medical device companies worldwide — including the FDA itself. It is purpose-built to help pharmaceutical, biotech, and medical device companies of every size — from pre-revenue startups to global enterprises — comply with FDA 21 CFR Part 11, 21 CFR Part 210-211, QMSR, EU GMP Annex 11 and Annex 22, ISO 13485, GxP requirements while accelerating quality operations. The platform provides integrated tools for managing documents, change control, training, quality events (including CAPA), audits, and risk, enhanced by compliant AI and real-time analytics. Role-based document control with built-in audit trails ensures proper versioning and access permissions; as documents are updated, prior versions are automatically archived so only the current, approved version is ever accessible. Qx automates training management by assigning tasks to affected employees whenever a controlled document changes, with recurring training, completion reminders, and a training matrix that gives auditors instant visibility into workforce readiness. Organizations configure quality event processes to match their own workflows using Advanced Quality Event Management (AQEM), adapting best-practice templates or building custom, no-code workflows — including form-to-form launching that lets a CAPA be triggered directly from a deviation or audit finding. MasterControl's patented Validation Excellence Tool (VxT) and Validation on Demand (VoD) reduce computer system validation from months to minutes, aligned with FDA Computer Software Assurance (CSA) guidance. MasterControl Insights delivers dashboards and analytics that help quality, manufacturing, and regulatory teams across North America, Europe, and Asia-Pacific visualize trends and act before they become audit findings.


Q. Does MasterControl Quality Excellence support mobile devices?

MasterControl Quality Excellence supports the following devices:
Android, iPhone, iPad


Q. What level of support does MasterControl Quality Excellence offer?

MasterControl Quality Excellence offers the following support options:
Knowledge Base, Email/Help Desk, Phone Support, FAQs/Forum, Chat

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