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.

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.

  • Devices

    Business size

    S M L

    Markets

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

    Supported Languages

    English

    Images

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

    Features

    Total features of MasterControl Quality Excellence: 84

    • Access Controls/Permissions
    • Action Management
    • Activity Tracking
    • Alerts / Escalation
    • Alerts/Notifications
    • Approval Process Control
    • Archiving & Retention
    • Audit Management
    • Audit Trail
    • Automated Routing
    • Automated Scheduling
    • Automatic Backup
    • Bills of Material
    • Business Process Control
    • Change Management
    • Charting
    • Commenting/Notes
    • Communications Management
    • Complaint Management
    • Compliance Management
    • Corrective and Preventive Actions (CAPA)
    • Cost Tracking
    • Customer Complaint Tracking
    • Customizable Reports
    • Dashboard
    • Data Import/Export
    • Defect Tracking
    • Design Management
    • Digital Signature
    • Document Check-in / Check-out
    • Document Coding & Control
    • Document Management
    • Document Review
    • Document Templates
    • Electronic Signature
    • Electronic Submission
    • 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
    • Internal Controls Management
    • Issue Tracking
    • Maintenance Management
    • Mobile Access
    • Multi-Location
    • Nonconformance Tracking
    • Operational Risk Management
    • Order Management
    • Periodic Review
    • Predictive Analytics
    • Prioritization
    • Project Management
    • Quality Assurance
    • Quality Control
    • Real Time Data
    • Real Time Reporting
    • Real-time Updates
    • Reporting & Statistics
    • Reporting/Analytics
    • Response Management
    • Revision History
    • Risk Assessment
    • Risk Management
    • Risk Reporting
    • Risk Scoring
    • Root Cause Analysis
    • Routing
    • Scheduling
    • Status Tracking
    • Supplier Management
    • Supplier Quality Control
    • To-Do List
    • Traceability
    • Training Management
    • Version Comparison
    • Version Control
    • Version Rollback

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    Reviews

    Overall rating

    4,5 /5
    (84)
    Value for Money
    4,2/5
    Features
    4,2/5
    Ease of Use
    4,1/5
    Customer Support
    4,6/5

    Already have MasterControl Quality Excellence?

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

    Write a Review!
    Showing 5 reviews of 84
    Joanne F.
    Overall rating
    • Industry: Hospital & Health Care
    • Company size: 10 000+ Employees
    • Used Daily for 2+ years
    • Review Source

    Overall rating

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

    MasterControl Quality Management system

    Reviewed on 2020/01/21

    MasterControl has allowed us to replace book shelves of policy binders, file cabinets of employee...

    MasterControl has allowed us to replace book shelves of policy binders, file cabinets of employee training and competency forms. Staff can all access the same document at the same time instead of waiting for the binder to be free. Regulatory requirements are easy to track within the system.

    Pros

    This system is flexible enough for a any regulated industry. It includes a document management module, employee training module, Quality module that included Deviations, CAPA, Change Control, non-Conformance; Quality, risk management, etc.

    Cons

    The suite of modules has not been certified as HIPAA compliant, except for the Documents module. Full HIPAA compliance is on their timeline for 3rd quarter 2020.

    Jon T.
    Overall rating
    • Industry: Medical Practice
    • Company size: 1 001-5 000 Employees
    • Used Daily for 6-12 months
    • Review Source

    Overall rating

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

    System Integration

    Reviewed on 2020/07/09

    We needed a validated system to replace our existing homegrown systems. The integration of the...

    We needed a validated system to replace our existing homegrown systems. The integration of the modules made this move a relatively painless one.

    Pros

    We went from several home grown or small scale products and rolled them all into one with MasterControl. It significantly lowered our risk, makes our processes more efficient, and streamlined ongoing system maintenance and support. Many systems are good about recording information (all the inputs) but don't put much effort into the outputs. MasterControl makes it easy to pull out the information you are looking for and schedule specific reports for delivery when needed.

    Cons

    Being new to the medical device world, the sign offs and approvals seems cumbersome, but I would expect those from any system in this arena. That was a little to get used to, but it is setting us up for success when it comes audit time.

    Clayton S.
    Overall rating
    • Industry: Medical Devices
    • Company size: 10 000+ Employees
    • Used Daily for 1+ year
    • Review Source

    Overall rating

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

    Enough for any regulated industry

    Reviewed on 2021/03/31

    MasterControl provided us everything we need for employee training. Use of paper records is not...

    MasterControl provided us everything we need for employee training. Use of paper records is not only impossible to control with a growing facility, it is a regulatory risk. The software is easy to use and definitely worth it. I can't speak to the report management side of it but I imagine it gets the job done as well based on what I have seen for training.

    Pros

    Plenty of features available, including CCM, CAPA, NCR and more. We mainly use it for management of employee training. Previously, we used a paper based training system. MasterControl is easy to use from a management side and the user end. Our employees got it right away and it worked like a charm at our facility. When new trainings are ready, they immediately get assigned.

    Cons

    Navigation can be a bit difficult. There are some features we would like removed just for ease of use for our employees, especially new employees. These are very minor criticisms and ultimately it does exactly what we want it to do.

    Susan E.
    Overall rating
    • Industry: Biotechnology
    • Company size: 201-500 Employees
    • Used Other 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 2020/09/30

    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]

    Deanna V.
    Overall rating
    • Industry: Medical Devices
    • Company size: 11-50 Employees
    • Used Daily for 1+ year
    • Review Source

    Overall rating

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

    Implementation of Doc and Training

    Reviewed on 2020/12/18

    We had a paper training process and used PDM for document control, which was not ideal because the...

    We had a paper training process and used PDM for document control, which was not ideal because the user had access to prior control document revisions. Once we were able to inventory our procedures and forms, we were able to implement a solution that is long term sustainable
    We know we hit the jackpot, when the [SENSITIVE CONTENT HIDDEN] of the company said that was able to do training very easily because the document was attached to the training. He didn't need to attend training on how to use the software to figure out how do complete his procedure assignment training.

    Pros

    1) For the user, it was very easy for the user to complete training. Steps are very intuitive
    2) Implemented a document control solution that prohibited certain users from seeing archived versions of the documents.
    3) each to find document by searching by datacard elements

    Cons

    didn't set up data card structure as best that we could.

    Showing 5 reviews of 84 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.

    We do not have any information about MasterControl Quality Excellence features

    MasterControl Quality Excellence has the following typical customers:

    2-10, 11-50, 51-200, 201-500, 501-1 000, 1 001+

    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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