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MasterControl Quality Excellence

Score8.5 out of 10

232 Reviews and Ratings

What is MasterControl Quality Excellence?

MasterControl Quality Excellence is a Quality Management System (QMS) for the life sciences. It enables life-sciences companies to enable flexible quality event management, simplified document management, and automated training management that work together to close the loop on quality.

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Pros

  • Robust document control, revision management, and approval workflows
  • Effective tracking and management of employee training and compliance
  • Streamlined workflow and approval processes for quality tasks

Cons

  • Steep learning curve and system complexity for new users
  • Limited and inconsistent search functionality for documents
  • Clunky and counter-intuitive user interface, especially in reporting

Master control review.

Use Cases and Deployment Scope

We use it to release new documents, including training guides and processes for our products, and company policies. This allows everyone to stay up to date with changes within the company and make sure they meet our standards. Some of the problems this addresses are gaps in training, learning new areas, transitioning to new roles, and laying the foundation for learning.

Pros

  • Keep associates up to date on training guides.
  • Easy to find documents.
  • Easy-to-use interface.

Cons

  • How documents are found.
  • How they are released to associates.
  • How they are assigned.

Return on Investment

  • Helps improve learning speed/productivity.
  • Decreases chances of failures.
  • Helps build knowledge and skills.

Usability

Assessment

Use Cases and Deployment Scope

We use MasterControl Quality Excellence as a quality system to upload files such as methodologies, protocols, change control documents, and evaluations. However, it has many problems with the submission of misformatted documents; the final file is different from what was submitted. The documentation package workflow is lost when a document is rejected; it lacks a well-defined and organized flow. It's not intuitive. Finding documentation is difficult, even using keywords.

Utilizamos como sistema da qualidade, para subir arquivos como metodologias, protocolos, controle de mudanças, avaliações. O MasterControl Quality Excellence tem muitos problemas com a submissão de documentos desconfigurados, o arquivo fica efetivo diferente do que foi submetido. o fluxo de pacote de documentação se perde quando é reprovado, não tem um fluxo bem definido e organizado. Não é intuitivo. Dificuldade em encontrar documentações mesmo com as palavras-chaves.

Pros

  • Link between documentation
  • email notifications
  • Link entre documentações
  • avisos por e-mail

Cons

  • find documentation
  • A well-defined rejection process, with greater visibility for it.
  • The actual document must be identical to the one submitted.
  • standardization of documentation
  • be more intuitive
  • encontrar documentação
  • fluxo de reprovação bem definido, maior visibilidade para isso
  • documento efetivo ser idêntico ao submetido
  • padronização das documentações
  • ser mais intuitivo

Return on Investment

  • I can't give an exact number, but the delay is significant.
  • não sei dizer em números, mas o atraso é grande.

Usability

Alternatives Considered

SAP HANA Cloud

Life Sciences Quality Management using MasterControl Quality Excellence.

Use Cases and Deployment Scope

MasterControl is my one-stop shop for an electronic quality management system. The software can handle all aspects of the life sciences and can tackle just about any situation that arises. We were able to incorporate other MasterControl modules to meet our demands, but the main module used is the Quality Excellence (Qx) module. The Quality Excellence module has been able to adapt to the company's needs and continues to evolve in response to future needs.

Pros

  • Continuous improvement in developing for future pipelines.
  • Robust system to ensure compliance.
  • Visually appealing user interface that is easy to understand.

Cons

  • License model can become very expensive for small startup businesses.
  • More development with validation and more transparent information on how the improvements and or fixes may impact the current configuration. Currently, everything is listed, but it is not tailored to my system.
  • More information regarding the transition of previous processes to new processes. i.e., FBS to AQEM. I am currently working on the ADV/FBS forms and will eventually transition to AQEM/ADAPT. Still, I would like more information regarding the transition to inform current stakeholders about the improvements on the horizon.

Return on Investment

  • MasterControl Quality Excellence has been able to shorten the time needed to complete document reviews as the options to alert users are abundant.
  • MasterControl becomes the center hub for the business as everything needs to be funneled through the EQMS. Therefore, new users understand the importance of utilizing the system.
  • The ROI has been difficult to see for stakeholders who do not use the system often or at all. This value is not readily visible to users who do not use the system.

Usability

Alternatives Considered

QAD Adaptive ERP, Oracle Access Management and SAP Access Control

Great Product Great Service

Use Cases and Deployment Scope

Our organization used MasterControl Quality Excellence as a document management and quality event handling system. MasterControl Quality Excellence addresses the problem are managing large amounts of documents efficiently and in a controlled manner. It really helped us get off a paper based system. AQEM has allow us to make a customized event handling work flow that provides all the features needed for design.

Pros

  • Document management
  • Event handling
  • Document control

Cons

  • Csv uploads to log books
  • More excel like function from insights.

Return on Investment

  • It’s positively impacted us by allowing the company to collaborate cross functionally from different locations

Usability

A MasterControl Quality Excellence Review

Use Cases and Deployment Scope

The MasterControl Quality Excellence platform addresses our problems by complying with 21CFR part 11 and improving productivity by switching all of our paper processes to electronic. MasterControl Quality Excellence also allows greater visibility into the productivity of our users and notifies them whenever a training is due or a task is assigned to them.

Pros

  • Document workflow management
  • Reporting
  • Traceability

Cons

  • The software is too complex for new users and takes a while for them to fully understand the functionality.
  • I would like to see how many licenses we have purchased and how many of those licenses are in use.
  • I would like more functionality for basic view only users in the aqem.

Return on Investment

  • Faster document processing
  • Increased visibility into productivity
  • Increased productivity amongst users

Usability