MasterControl

MasterControl

Enterprise Quality Management

4.6/5 (61 reviews)

MasterControl Overview

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
$1000/month
Pricing options
Free Trial
Subscription
Value for money

Devices

Business size

S
M
L

Markets

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

Supported Languages

English

MasterControl Reviews

Overall rating
4.6/5
93% positive reviews
43
Excellent
14
Very good
4
Average
0
Poor
0
Terrible

The 'Adobe' of eQMS: Extremely powerful functionality with a learning curve well worth the effort.

Used Daily for 2+ years
Reviewed on 8/30/2017
Review Source: Capterra

Increased productivity, compliance, visibility, and capability.

Pros

1) One-stop shopping for Document Control, Training, CAPA, Complaints, Change Control, Supplier Management, Bill of Materials, etc. All processes are electronically linked, adding both ease and traceability to my interrelated QMS processes (I can launch a CAPA from my Complaint form!) (I can launch an Engineering Change Order from my CAPA form!)
2) Configuration can be as simple or as complex as you make it. The more complex configurations are more work up front, but bullet-proof the processes for the end-user so the processes pretty much drive themselves.
3) Makes audits so much easier to facilitate and eliminates the low-hanging fruit that is so easy for auditors to find; no missed signatures, no GDP issues, no data integrity concerns, etc.
4) Technical Support has my questions answered almost immediately whether I call directly or issue a web-ticket. More complex questions are escalated directly to the engineers who are also incredibly responsive.
5) My product feedback is solicited and responded to. MasterControl isn't an unreachable entity; they care what the end user has to say and are constantly soliciting feedback.
6) Form Builder! The eForm Builder and Process module are addictive. I can build an HTML for for any time-wasting paper-based process that I have. They go through the electronic workflow and can link to any other MasterControl module, form, etc.

Cons

1) The cost is understandably high (it does the work of 2-3 people in my 80 person company) but it can be difficult to get management past the sticker shock when they're thinking of traditional plug-and-play software (and asking management to spend money on Quality is already tough).
2) As mentioned in the opening line, the learning curve is a bit steep. This is not a drag-and-drop, push-to-install software. You need a trained System Administrator to navigate not just how to do the basics, but how to really harness the full, powerful potential of the software. Buying the software, attending one intro courses and then calling it good is like buying an espresso machine only for the hot water. You need to learn what all the buttons do to make it a real, worth-while investment. Luckily MasterControl has an Online University with really helpful tutorials, plus a great online help menu. And Tech Support for everything else.

Rating breakdown

Value for Money
Ease of Use
Customer Support

Likelihood to recommend

10.0/10

Amazingly Robust, Compliant and Easy to Use

Used Daily for 2+ years
Reviewed on 8/30/2017
Review Source: Capterra

Pros

I've been the Administrator of this software at our company for over 10 years. We currently utilize the Documents, Process and Training modules along with a few HTML based eForms such as Change Control, Manufacturing logs, etc. The collaborative tool for reviewing and redlining documents has provided the necessary exposure and transparency to our organization on document reviews. In addition, we've kick it up in our training module by purchasing and utilizing UL Eduneerings Compliance modules which is SCORM compliant. Works great and eliminates the use of going outside of MasterControl to complete compliance training.

Over the years, MasterControl has made significant improvements to provide more automated functions that reduce human error. We've taken advantage of those tools. The proof really is in front of regulatory agencies such as FDA, Notified Body, TGA, etc where every time I was audited for he functions I managed (Document Control, Training, Change Management, Records Control and HR), I was able to demonstrate controls and compliance over the entire Document, Training and Change Management systems. We've received high remarks from these agencies on system.

Cons

Like any software, there are various issues, albeit out of the control of MasterControl at times. For instance, MasterControl may not behave the same in various versions of Internet Explorer. MasterControl is good to call out in their Hardware/Software Recommendations document what systems and software plays naughty and nice with their system (e.g. I.E, Java, Google Chrome, Adobe, Servers, etc).

What's in their control that is not so great is the reporting tool. However, that should be addressed later this year.

Rating breakdown

Value for Money
Ease of Use
Customer Support

Flexibility for all specialties with great modules for your regulatory needs.

Used Daily for 2+ years
Reviewed on 9/6/2017
Review Source: Capterra

Removed all SOP binders in our department. Staff training records also eliminated and are all in soft copy and easy to find. MasterControl makes documentation management easy. Regulatory agencies that review our sites are impressed with the system and ease in finding what they have requested.
Department supervisors were able to eliminate many lists reminding staff of document review dates, required reading and new information. Staff meeting minutes no longer left in a break room for staff to read and initial. MasterControl sends it out to appropriate staff and requests an electronic signature.
The internal report writer is easy to use and presents real time data in seconds.

Pros

This application is installed at a university hospital with many diverse regulatory needs. From CLIA and CAP in Pathology and Clinical Laboratories to AABB and FACT in Bone Marrow Transplant programs. Documents, Training and Process modules are flexible enough to meet the diverse needs of each specialized department while allowing the departments to tailor the system to meet their workflow needs. All documents are available to the staff that need them in the most recent version wherever they need them. We utilized PC's, laptops, iPads and hyperlinks within departments Intranet sites. Completing all template fields allows for great automation and the elimination of lists of due dates, signature lists and manual training tracking.

Cons

For staff that do not author/edit documents routinely it can be hard to know where to begin in the application. We upgrade every 2 years and the design can significantly change enough to confuse people.

Rating breakdown

Value for Money
Ease of Use
Customer Support

Likelihood to recommend

10.0/10

Possibilities are Endless!

Used Daily for 2+ years
Reviewed on 9/5/2017
Review Source: Capterra

Pros

There are so many opportunities to use this software to help manage aspects of your business or quality system that would be impossible in a paper based or manual process. While the modules are defined and designed around a specific function, you have the flexibility to create custom configurations and shape the product to fit your needs. The customer support from the entire MasterControl group is amazing!The level of service is very high from everyone you interface with, the sales team, the install team, the front-line support team, etc. We also use the TAM support service in addition to front-line support and we have greatly benefited from building a relationship with our TAM and troubleshooting system issues. Overall, this investment will help support rapid growth in your business and help facilitate the creation and management of a truly robust quality organization.

Cons

There is definitely a learning curve with this software for users, and with the size of our organization and the constant influx of new personnel the establishment of an ongoing support team is key to the success of the product. Some of the components are not the best out of the options available on the market, but bringing them all together in one package is what makes this product sustainable.

Rating breakdown

Value for Money
Ease of Use
Customer Support

Likelihood to recommend

10.0/10

MasterControl software meets the regulatory requirement for automated systems.

Used Daily for 2+ years
Reviewed on 9/11/2017
Review Source: Capterra

Pros

All modules revolve around the infocard which is used to establish documents, training, audits, suppliers etc. Once you understand how to configure the infocard for one module, it is very easy to configure add additional modules to support the quality system. We started with the documents module and have expanded to include training, complaint, audit, supplier, non-conformance and a few customer forms. We have done most of our own configuration with minimal assistance. We also like the info card set up because it makes it so easy to file all product related documents in one location. We recently set up an infocard for each specific item and we have been to link specific suppliers, inspection reports and other item qualification activities directly to the info card. This allows for easy access in the event of an audit from an outside agency.

Cons

Customization of the out-of-the-box software version is very challenging. Also, the audit module is not very user friendly. A "work add-in" is needed on versions 11.4 and prior in order to generate an audit checklist and subsequent report. Installing the word add-in is difficult when the software is maintained behind a firewall.

Rating breakdown

Value for Money
Ease of Use
Customer Support

MasterControl Pricing

Starting from
$1000/month
Pricing options
Free Trial
Subscription
Value for money

Contact MasterControl for detailed pricing information.

MasterControl Features

  • Access Control
  • Activity Tracking
  • Auditing
  • Compliance Management
  • Customizable Reporting
  • Data Import/Export
  • Real Time Data
  • Reporting & Statistics

  • API
  • Activity Dashboard
  • Audit Trail
  • Automatic Notifications
  • Custom Fields
  • Document Storage
  • Inventory Management
  • Inventory Tracking
  • Invoice Management
  • Monitoring
  • Third Party Integration
  • Workflow Management

Additional information for MasterControl

Key features of MasterControl

  • Advanced reporting capabilities
  • Approval of all documents-based processes
  • Automate assignment and monitoring of training tasks
  • Automate scheduling, follow-up, tracking, escalation, review
  • Automate, streamline, and manage the audit process
  • Automated task assignment/routing
  • Best-practice "8D" process
  • Change control
  • Corrective actions (CAPA)
  • Corrective and preventive action system
  • Customer complaints software
  • Customizable reports
  • Defect tracking
  • Document approval
  • Document control
  • Electronic submissions
  • Forms-based processes automation
  • Group sign-off
  • ISO standards management
  • Incident management
  • Nonconformance automation software
  • Priority levels
  • Quality audit management
  • Real-time status
  • Risk assessment and classification
  • Sequencing of training courses
  • Streamline the change control procedure
  • Templates
  • Tracking capabilities
  • Training management

Benefits

  • 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.

  • MasterControl FAQs

    Below are some frequently asked questions for MasterControl.

    Q. What type of pricing plans does MasterControl offer?

    MasterControl offers the following pricing plans:

    Starting from: $1000/month

    Pricing model: Subscription

    Free Trial: Not Available

    Contact MasterControl for detailed pricing information.

    Q. What are the main features of MasterControl?

    MasterControl offers the following features:

    • Advanced reporting capabilities
    • Approval of all documents-based processes
    • Automate assignment and monitoring of training tasks
    • Automate scheduling, follow-up, tracking, escalation, review
    • Automate, streamline, and manage the audit process
    • Automated task assignment/routing
    • Best-practice "8D" process
    • Change control
    • Corrective actions (CAPA)
    • Corrective and preventive action system
    • Customer complaints software
    • Customizable reports
    • Defect tracking
    • Document approval
    • Document control
    • Electronic submissions
    • Forms-based processes automation
    • Group sign-off
    • ISO standards management
    • Incident management
    • Nonconformance automation software
    • Priority levels
    • Quality audit management
    • Real-time status
    • Risk assessment and classification
    • Sequencing of training courses
    • Streamline the change control procedure
    • Templates
    • Tracking capabilities
    • Training management

    Q. Who are the typical users of MasterControl?

    MasterControl has the following typical customers:

    Large Enterprises, Mid Size Business, Small Business

    Q. What languages does MasterControl support?

    MasterControl supports the following languages:

    English

    Q. What type of pricing plans does MasterControl offer?

    MasterControl has the following pricing plans:

    Subscription

    Q. Does MasterControl support mobile devices?

    We do not have any information about what devices MasterControl supports

    Q. What other apps does MasterControl integrate with?

    MasterControl integrates with the following applications:

    Microsoft Excel, Microsoft Powerpoint, Microsoft Word

    Q. What level of support does MasterControl offer?

    MasterControl offers the following support options:

    Knowledge Base, Online Support, Phone Support