About MasterControl Quality Excellence

MasterControl is an electronic quality management system (eQMS) that enables life science companies to eliminate paper-based quality processes, and observe regulatory standards. With MasterControl, organizations can improve on compliance with FDA regulations and ISO quality standards, while increasing manufacturing efficiency and product quality.

The web-based solution helps organizations automate GxP processes, and link each stage in a product's development lifecycle with every department. Automated routing and escalation help ensure quick responses to inputs from departments such as engineering, regulatory, manufacturing, QA, sales and marketing.

MasterControl's eQMS helps automate and streamline document, change, and training control, as well as corrective/preventive action (CAPA), audits, customer complaints, and other quality and business processes. The solution helps users with automating task assignment, scheduling, tracking, escalation, follow-up and more.

Training management features include assignment automation and tasks monitoring, as well as the sequencing of training courses. MasterControl’s nonconformance features help identify, evaluate, review and handle nonconforming materials. Quality audit management helps track basic audit information and findings, and automates the scheduling of recurring audit-related activities. Users can streamline the complaint-handling process using a multi-page form that customers can access from virtually anywhere.

Pricing starting from:

Not provided by vendor

  • Free Version
  • Free Trial
  • Subscription

Key benefits of MasterControl Quality Excellence

  • MasterControl enables users to streamline and automate task assignment/routing, scheduling, escalation, tracking, follow-up, review, and approval of all documents-based processes.

  • The MasterControl CAPA system tracks incidents and guides quality teams through CAPA implementation.

  • Customizable reports provide users with real-time status reports of the entire quality system, including change control tasks.

  • MasterControl streamlines complaint-handling with a simple, three-stop process in a pre-configured, multi-page form.

  • MasterControl facilitates electronic submissions of FDA applications, and provides assembling control and documentation tracking.

  • MasterControl was the world's first Quality Management System to become CFR 21 Certified. We also offer solutions for FDA, ISO, and Non-regulated/Non-compliance.
  • Typical Customers

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

    Deployment

    • Cloud-based
    • On-premise

    Markets

    Australia, Canada, China, Germany, France , United Kingdom, Japan, United States

    Supported Languages

    English

    Pricing starting from:

    Not provided by vendor

    • Free Version
    • Free Trial
    • Subscription

    Images

    MasterControl Quality Excellence Software - MasterControl's main menu and dashboard modules
    MasterControl Quality Excellence Software - Track and organize documents electronically and create folders
    MasterControl Quality Excellence Software - The module handles every type of document, regardless of the software used to create it
    MasterControl Quality Excellence Software - Record important information in the module's Document InfoCard
    MasterControl Quality Excellence Software - Efficient automated paths for complaints
    MasterControl Quality Excellence Software - A validated customer complaint can be used to launch issue review processes
    MasterControl Quality Excellence Software - Simple drag-and-drop calendar for avoiding scheduling conflicts
    MasterControl Quality Excellence Software - Within the supplier module, vendor lists are tracked and approved in a centrally connected location
    View 9 more
    MasterControl Quality Excellence video
    MasterControl Quality Excellence Software - MasterControl's main menu and dashboard modules
    MasterControl Quality Excellence Software - Track and organize documents electronically and create folders
    MasterControl Quality Excellence Software - The module handles every type of document, regardless of the software used to create it
    MasterControl Quality Excellence Software - Record important information in the module's Document InfoCard
    MasterControl Quality Excellence Software - Efficient automated paths for complaints
    MasterControl Quality Excellence Software - A validated customer complaint can be used to launch issue review processes
    MasterControl Quality Excellence Software - Simple drag-and-drop calendar for avoiding scheduling conflicts
    MasterControl Quality Excellence Software - Within the supplier module, vendor lists are tracked and approved in a centrally connected location

    Features

    Total features of MasterControl Quality Excellence: 90

    • Access Controls/Permissions
    • 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 Reports
    • 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
    • For Small Businesses
    • Forms Management
    • Full Text Search
    • ISO Compliance
    • ISO Standards Management
    • Incident Management Software
    • Internal Controls Management
    • Inventory Management Software
    • Issue Tracking Software
    • MES
    • Maintenance Management Software
    • Material Requirements Planning
    • 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
    • Traceability
    • Training Management
    • Version Comparison
    • Version Control
    • Version Rollback
    • Workflow Management Software

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    Reviews

    Overall rating

    4.5 /5
    (191)
    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 191
    Matthew
    Overall rating
    • Industry: Pharmaceuticals
    • Company size: 51-200 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

    Great software and reasonable pricing

    Reviewed on 10/26/2022

    I have been extremely satisfied with almost every aspect of MasterControl since my first exposure...

    I have been extremely satisfied with almost every aspect of MasterControl since my first exposure to it in 2009!

    Pros

    Once learned, the interface is quite intuitive and understandable, even internationally. As with all software, it is never perfect in all ways, but MasterControl is laser focused on constant product improvement and innogeering excellence.

    Cons

    Sometimes new user acceptance is difficult, depending on their level of frequent use. But the more they ate exposed to it, the faster they learn and the flatter the learning curve.

    Carina
    Overall rating
    • Industry: Medical Devices
    • Company size: 11-50 Employees
    • Used Daily for 6-12 months
    • Review Source

    Overall rating

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

    Leader in Document Control Systems

    Reviewed on 2/3/2020

    The ability to keep all documents in one location with visibility being managed by rights in the...

    The ability to keep all documents in one location with visibility being managed by rights in the system reduces the concerns in our previous paper-based system. Also the approval process being electronic reduces delays from those out of town who can now sign wherever they are.

    Pros

    The configuration abilities that allow you to make adjustments that apply most directly to your company.

    Cons

    The implementation of the software wasn't as clear and smooth as we needed.

    Alternatives Considered

    Greenlight Guru

    Reasons for Switching to MasterControl Quality Excellence

    MasterControl is a much larger platform that allows connection across many elements. Their obvious success with Document Management made them difficult to beat.
    Susan
    Overall rating
    • Industry: Biotechnology
    • Company size: 201-500 Employees
    • Used for 2+ years
    • Review Source

    Overall rating

    • Ease of Use
    • Likelihood to recommend 0.0 /10

    Most unintuitive software I've ever been forced to use

    Reviewed on 9/30/2020

    There are company-wide jokes about "Master Control Hell". At least it lets us bond in our...

    There are company-wide jokes about "Master Control Hell". At least it lets us bond in our commiseration.

    Pros

    Umm... that's really hard to say. Pretty colors, I guess.

    Cons

    Navigation is difficult.
    "Help" is convoluted - no easy way to find answers. For example, I wanted to know where my task disappeared to after I clicked Launch. Could not find an answer.
    App stalls very often with back button.
    I could go on, but I'm tired. I've been trying to navigate Master Control for the last 3 hours.

    Response from MasterControl

    We are sorry to hear that you were having trouble navigating the MasterControl product. We understand how important the user experience is, and work diligently to bring the best possible features to our latest product version. We would love to work with you directly to see how we can improve your MasterControl experience. If this is of interest to you, please contact us at [email protected]

    Justin
    Overall rating
    • Industry: Biotechnology
    • Company size: 51-200 Employees
    • Used Daily for 2+ years
    • Review Source

    Overall rating

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

    Feature Rich and Compliant eQMS

    Reviewed on 11/23/2022

    Like many MC users, we started with doc control and training. This allows us to technologically...

    Like many MC users, we started with doc control and training. This allows us to technologically link the two processes together. New revision to an SOP? Training automatedly is sent to users. Want to ensure training is complete before release? MC can delay the release until a specified amount of training is completed. MC also provides QEM solutions which can further support all other aspects of the QMS.

    Pros

    MC provides a solid framework for any QMS. You are able to adapt any process into MC with minimal modification. MC is also a fully integrated platform and nothing in the software works in isolation. Training, document control, QEM; all of it works together.

    Cons

    MasterControl isn't intuitive. There is a lot of training that needs to go into its use, especially if the person is doing more than just accessing SOP and performing training. However, MC does provide A LOT of training resources which takes some of the burden off of admins.

    Aubrey
    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 Software
    • Likelihood to recommend 7.0 /10

    Increased compliance and efficiency

    Reviewed on 11/18/2022

    The overall experience has been great. The pros much outweigh the cons. We are looking forward to...

    The overall experience has been great. The pros much outweigh the cons. We are looking forward to MasterControl expanding features even more and learning how to better use our existing ones.

    Pros

    Document control has been the most impactful. We are not losing documents, manually tracking them down, and can now approve from anywhere. Our compliance has dramatically improved and also our efficiency.

    Cons

    There are still some gaps in features to make a quality system entirely paperless. We are not able to transition logs over because they don't entirely fit anywhere. FBS forms do not have the functionality we are looking for. We use Mx a lot as fillible forms for things such as donor screening and QC testing where more calculations and documentation are required.Configuration can be difficult depending on who the consultant is. You get a broad range and a different experience with each different person, some more pleasant experiences than others.

    Showing 5 reviews of 191 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:
    • 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.