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MasterControl Quality Excellence

MasterControl Quality Excellence


What is MasterControl Quality Excellence?

The MasterControl Quality Excellence suite bundles a number of products supporting work quality and compliance including training and exams, incidents and corrective actions (CA), documents and change, and other modules.

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Users of MasterControl Quality Excellence have found that the product offers numerous benefits and solves a range of challenges. One key …
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What is MasterControl Quality Excellence?

The MasterControl Quality Excellence suite bundles a number of products supporting work quality and compliance including training and exams, incidents and corrective actions (CA), documents and change, and other modules.

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Product Details

What is MasterControl Quality Excellence?

MasterControl is a QMS for for pharmaceutical & medical device mid-market to enterprise companies (50 – 10,000+). An integrated cloud-based quality and compliance software designed for regulated industries across the product development life cycle. MasterControl states their goal is to bring life-changing products to more people sooner through offering a closed loop eQMS with audits, training, document control, CAPA, SOP, regulatory compliance, validation & supplier management. The platform helps organizations digitize, automate and connect quality and compliance processes across the regulated product development life cycle.

MasterControl Quality Excellence Features

  • Supported: Digital Document Management: Cloud architecture and a secure system to digitally vault and manage documents.
  • Supported: Change Control: Tools to handle policies, work instructions, and engineering change.
  • Supported: Training and Exams: Automates training tasks from routing and tracking to follow-up and escalation.
  • Supported: Quality Events and CAPA: Automates the process of managing CAPAs
  • Supported: Compliance and Audit Management
  • Supported: Risk Management
  • Supported: Data Analytics and Insights

MasterControl Quality Excellence Videos

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MasterControl Quality Excellence Technical Details

Deployment TypesOn-premise, Software as a Service (SaaS), Cloud, or Web-Based
Operating SystemsWindows, Linux, Mac
Mobile ApplicationNo
Supported CountriesGlobal
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Reviews and Ratings


Community Insights

TrustRadius Insights are summaries of user sentiment data from TrustRadius reviews and, when necessary, 3rd-party data sources. Have feedback on this content? Let us know!

Users of MasterControl Quality Excellence have found that the product offers numerous benefits and solves a range of challenges. One key use case is that it allows users to focus on their business operations without worrying about document and training management. The automated document revision control feature has proven to be particularly valuable, saving users a significant amount of time. Additionally, MasterControl makes it easier for users to prepare for client audits by providing easily retrievable training data and documents.

Implementing MasterControl has revolutionized the document processing capabilities of many organizations, reducing the time it takes to process engineering change notices for a single document controller. Users also appreciate the excellent customer service provided by MasterControl. Overall, users express their satisfaction with the product's performance and find it easy to use. By replacing paper-based processes with MasterControl, businesses have been able to streamline their operations, enhancing efficiency and productivity. While there may be some initial confusion in understanding how all the modules work, once mastered, users have found that MasterControl is a versatile tool that can be adapted to meet their specific needs.

Attribute Ratings


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Score 9 out of 10
Vetted Review
Verified User
MasterControl Spark allowed us to move from a paper-based quality system to a paperless system. Considering our organization was expanding to different locations across Canada, we could no longer keep up with a paper-based system. MasterControl Spark made it possible for us to do so smoothly. This change at the beginning was painful and time-consuming, but we allotted the required labour to finish it. The process took around four months for installation and training.
  • Document control
  • Deviation control
  • Training
  • Pricing is way too high and it is not affordable for smaller companies
  • UI could be more attractive to the general users
  • Assigning a specific person as account manager would be great
MasterControl Spark allows you to get rid of binders and papers, and you don't need to copy, share and distribute documents to your staff. The most important part is the inspectors or auditors like it, and you can pass the inspections with fewer observations. If your company has multiple offices in different geographical locations, then MasterControl Spark could help keep your quality systems up to date and efficient. In addition, MasterControl Spark probably enables you to remove one or more staff and save some cost on your staffing.
  • Time saving
  • Keeping documents updated and accurate
  • Make training easier
  • We need fewer employees at quality department
  • We spend less time to respond observations
  • We trust more with the material and records
They are in the pharmaceutical manufacturing business, and it is evident that such companies' requirements and record keeping are critical factors. Preparing, filing and archiving paper records is a very time-consuming procedure, and it is associated with many human errors. At the same time, a paperless system could decrease or eliminate those human errors and speed up reviewing and approving quality documents.
The internal support individuals don't need to have any special qualifications. Usually, they get trained by the MasterControl specialists and then can support other companies' internal staff. However, the MasterControl helpdesk is always available to help staff and system admins if that is required.
  • SOP writing and archiving
  • Training of staff on new SOPs or changes
  • Keep record of issues and noncompliances
  • We use MasterControl Spark for some other controlled documents like job descriptions and master plans
  • We use MasterControl Spark as a way of communications between SOP author team members
  • We use the CAPA module to record and keep history of audits and observations
  • Using the training module
  • Using the auditing module
  • Using the change control module
During the past five years, we expanded our business and its quality control, and we hadn't had any issues even when we grew the company's size around five times. The software has proved itself during these years, and now we rely on it heavily and don't think we need to switch to any other similar product in the near future.
  • Product Features
  • Product Reputation
As a company in an expansion situation, it was tough for the quality systems to catch up with the expansion speed, especially when it was supposed to respond to the regulatory agency audit observations. In addition, the number of staff was limited, and the company was not ready to hire more staff in every new location. The only viable solution for the company was to move from a paper-based quality system to a paperless one to decrease the quantity of the required staff.
I don't think there would be any change if we want to evaluate and select a similar product. There might be some other new players in the market which may I am not aware of them but considering the history and creditability of MasterControl Spark, I still recommend it as a perfect solution for a paperless quality system.
Joanne Foster | TrustRadius Reviewer
Score 9 out of 10
Vetted Review
Verified User
MasterControl has been used at our healthcare system since 2012. It is utilized by various clinical departments including the Pathology Department, Clinical Laboratory, Bone Marrow Transplant Services, etc. It is to record deviations, CAPA, document control and staff training relayed to documents and competencies. We are a regulated industry and document control is required by several of our regulators. After a long search, MasterControl was selected because of its versatility to be used for many different departments including Blood and Biologics and Manufacturing departments.
  • MasterControl removes the needs for book shelves of binders through out multiple sites. Keeping all the binders up to date is a manual process and takes time, space and lots of duplication of paper. There is an electronic copy available to those who need it from any device in house. The most recent version is always available.
  • MasterControl has security in place so those with a need to know have access to their documents, while blocking other departments from even seeing the content of others. All actions are recorded in an audit trail for users and documents.
  • Document, Training and Quality modules all link together. A deviation will link to the document deviated against, which can create an action to edit the document or retrain selected staff on the documents contents.
  • Their new report writer is not user friendly yet. MasterControl has listened to its clients and have been making small changes to assist reporting. There is still room for improvement though.
  • Rapid company growth means many new staff. Some tech support staff know less than the customers they are supporting.
MasterControl is very flexible in all modules. A manufacturing department and a nursing unit can both use the same modules with all their needs met. System configuration can be accomplished at a broad and or granular level. Each document, incident, user etc can have a customized configuration for its unique workflow. The application is web-based and available on a variety of platforms. Security allows staff to access what they need from the workplace, remotely from a client site to home. While I work in healthcare, I can talk to other MasterControl clients in the oil industry or Pharma and we still can provide suggestions to each other about new or unique uses for MasterControl. I
  • Decreased costs related to copying documents, folders to track training, employee time replacing documents in all binders and the time to find the binders.
  • Access to current documentation is no longer limited to finding binders and having to share them.
  • Quality processes are looped in with the documentation and training to complete the circle of change required when a complaint or deviation exists.
  • Licensing can be costly as users must hold a license plus a annual maintenance fee.
SharePoint and DocSTAR were reviewed as well as 6 others. None of them provided that flexibility that MasterControl did. MasterControl had all the whistles and bells other systems did, but it offered for customizations to let us include clinical ancillary services, nursing units, outpatient clinics, product manufacturing etc. All its modules are linked together so processes are streamlined and automated. The cost is more than several other systems, but it makes up for it in its customer service and flexibility. MasterControl does value its customers and does take client suggestions to new enhancements routinely. Clients routinely get together on virtual meetings to assist each other and provide suggestions to MasterControl.
The Technical Support team has grown exponentially over the last couple years. Some front line support staff are new to the system and so know less than the clients do. Back line staff are more seasoned and provide immediate assistance to the front line staff. They have an extensive knowledge bank to assist them as well as client access to most KB articles. Annual user group conference gives us chance to meet the support staff an also to resolve any outstanding issues. Any critical vendor notices are emailed immediately when found and a patch offered at the same time. These are rare, but quickly resolved.
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