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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

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

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

MasterControl Qx with Life Sciences.

Use Cases and Deployment Scope

MasterControl is Aldevron’s eQMS, which encompasses various components that support compliance. The primary uses for the system are: Documentation storage. Non-executed templates and executed versions of documents are stored within the system and used for initiating, approving, and storing quality items within the process and AQEM modules, such as Quality Events/Deviations, Out of Specification (OOS) items, Invalids, CAPAs (Corrective and Preventive Actions), and Change Controls. Aldevron’s training management system captures copies of physical training documents as well as electronic training documents (such as read and understood training for SOP reading).

Pros

  • Documentation storage.
  • Training management system.
  • Launching/Approving Quality eForms.
  • Listing all our clients and suppliers.
  • Adding Ax

Cons

  • AQEM
  • JReports and Insights.
  • Prereqs for trainings.

Return on Investment

  • Less time locating documents.
  • Training module is great for record keeping.
  • Reporting could be improved.
  • Having personal support is highly needed.

Usability

Alternatives Considered

AssurX and Biovia

Other Software Used

LabVantage

MasterControl Qx Review from medical device manufacturer.

Use Cases and Deployment Scope

We use Quality Excellence for documents and training across multiple manufacturing sites for our organization. MasterControl has helped us reduce the amount of places documents are kept and keeps training compliance at the forefront. Before MasterControl are documents in training were not all electronic and not harmonized across locations.

Pros

  • Training doc admins on how to use the documents and training modules has been simple.
  • The ability to link training to production records to check for training compliance has been a really great feature of the link between QX and MX.
  • You were able to set up roles in each vault to allow access to the right people seeing the right documents.

Cons

  • On the job training certification would be a great feature for the training module.
  • It would be nice to have the change details be able to be published on the published PDF of a document.
  • When you launch a task, go directly into that task collaboration instead of going back into the start task window

Return on Investment

  • We have been able to whittle down the number of databases that our documents are kept in from well over 50 to a single location in MasterControl.
  • We've been able to convert paper training records into electronic training records when using MasterControl, which is saved a lot of time on the production floor keeping track of training.
  • By having the same tool and format across multiple places in the business it has helped the organization become more efficient.

Usability

Other Software Used

Kneat, Microsoft 365, Aras PLM