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: 93

    • Access Controls/Permissions
    • Action Management
    • Activity Tracking
    • Alerts / Escalation
    • Alerts/Notifications
    • Approval Process Control
    • Archiving & Retention
    • Audit Management
    • Audit Trail
    • Automated Routing
    • 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
    • Periodic Review
    • 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

    Alternatives

    TrackWise

    3.9
    #1 Alternative to MasterControl Quality Excellence
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    SmartSolve

    4.1
    #2 Alternative to MasterControl Quality Excellence
    SmartSolve is a SaaS enterprise complete QMS, vigilance and post-market surveillance, supplier, compliance, and risk...

    Greenlight Guru

    4.5
    #3 Alternative to MasterControl Quality Excellence
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    Qualityze Suite

    5
    #4 Alternative to MasterControl Quality Excellence
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    Reviews

    Overall rating

    4.5 /5
    (95)
    Value for Money
    4.1/5
    Features
    4.1/5
    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.

    Write a Review!
    Showing 5 reviews of 95
    Joanne
    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 Software
    • 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.

    Deanna
    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 Software
    • 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.

    Alternatives Considered

    TrackWise

    Reasons for Choosing MasterControl Quality Excellence

    paper controlled process for training and change control that was not regulatory compliant and couldn't be sustained.

    Reasons for Switching to MasterControl Quality Excellence

    functionality
    Babs
    Overall rating
    • Industry: Pharmaceuticals
    • 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 6.0 /10

    Middle-of-the-road quality system

    Reviewed on 2022-02-08

    Pros

    - Often includes impressive enhancements to the system between version updates
    - Useful knowledge base that can be leveraged for troubleshooting defects or common issues
    - Excellent document control
    - Ability to implement Enterprise Business Units is useful for managing more than one business unit in the system

    Cons

    - Navigation can be challenging for end-users with both limited or expansive access and rights to the system
    - Lack of GUI customization
    - Occasional defects have caused quality issues
    - jReports isn't completely user friendly therefore incorrect usage can slow down the system
    - On-demand self-led library is not free which contains excellent resources that can be leveraged for end-user education and/or troubleshooting purposes

    Jon
    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 Software
    • 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.

    Alternatives Considered

    Greenlight Guru, TrackWise, ETQ Reliance and SmartSolve

    Reasons for Switching to MasterControl Quality Excellence

    MasterControl was a mature system with many features more advanced over the competitive products. The sales team was fully engaged, offered as many demos as we needed, answered every question, and was super responsive. The reporting, the online collaboration, the integrated modules, and the flexibility of the solutions to meet our specific company needs were the main drivers. It helped that we had an internal resource that was previously a power user who had a good experience as well as customers who had previous positive experiences with MasterControl.
    Debbie
    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 Software
    • Likelihood to recommend 9.0 /10

    Quality Changes Everything

    Reviewed on 2020-05-15

    We are currently upgrading from and older version of MasterControl to their new cloud based...

    We are currently upgrading from and older version of MasterControl to their new cloud based offering and the updates to the training module will make keeping track of employees training status much quicker and easier.

    Pros

    The user interface makes this software so much easier to use than others that I have tried, even the most technophobic people in our organisation are willing and able to get on with MasterControl

    Cons

    There are a couple of areas where we would like to hide or remove buttons so that they don't confuse the end user, but I'm sure these suggestions will be looked at the way MasterControl evaluate all customer feedback and will eventually be implemented.

    Alternatives Considered

    Q-Pulse

    Reasons for Switching to MasterControl Quality Excellence

    Offered everything that we needed in a much cleaner and easier to use package
    Showing 5 reviews of 95 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:

    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

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