Opiniones de MasterControl Quality Excellence

Good system

Puntos a favor:

Everything is on one place, it's easy to control documents and manage training

Puntos en contra:

It's quite clunky sometimes, for example rejecting documents, managing fbs forms, audit module on it's own

MasterControl Quality Excellence: A Quality Product

Comentarios: Overall, MasterControl has been an excellent system to implement, decreasing the processing time of documents and allowing changes that need to be made quickly happen.

Puntos a favor:

Quality Excellence is an extremely robust and customizable system that allows the users to create custom workflows for their document control processes. These workflows can be generalized for maximum usage across documents or specialized for an almost hands-off experience in the system.

Puntos en contra:

The nuance of using the system can have a fairly steep learning curve. Currently, we are still finding little quirks in the system that can't be called generally good or bad. Just the fact that we are still learning different facets of the system tells how much there is to learn when using the system.

Overall, I'm satisfied, but there are areas I want to improve on the MasterControl

Comentarios: Many authority errors occur, and complaints from users often occur. If this part is improved, the other parts are generally satisfied.

Puntos a favor:

It is easy to manage documents and quality issues. In particular, the "Report function" can be customized and used, so it is possible to grasp the real-time status.

Puntos en contra:

It's inconvenient that I can't set up in detail during my absence. I wish I could do each of the absent settings for each permission.

Qx is Great for the Life Sciences Industry

Comentarios: Overall my experience has been great! I was handed a system that was in use for 2 years without a sysadmin as well. The software was very intuitive and easy for me to grasp immediately with minimal training.

Puntos a favor:

It consolidates all of our companies information into one location and everything is neatly tied together.

Puntos en contra:

The fact that the use of most symbols can cause unwanted defects.

A complete eQMS system

Puntos a favor:

It's relatively easy to setup and use. The MasterControl team really listens.

Puntos en contra:

It is expensive, but on par with other systems. Still waiting for a validation module.

Qx is beginning to revolutionize our QMS

Puntos a favor:

Document control, change control, and review workflows are among the biggest challenges facing our organization. MasterControl provides the means to apply industry best-practices, and excellent control and compliance, with intuitive, out-of-the box solutions. MasterControl Qx also integrates with MasterControl's Mx (Manufacturing Execution) system, a critical reason we chose it.

Puntos en contra:

Onboarding has been challenging. This is not a flaw in MasterControl, but rather a feature: Connections, workflows, training, responsibilities, review cycles ... all have to be specified in detail. We didn't necessarily have all the information arranged in such a way as to make its entry into MasterControl 'easy'. However, once put together, the MasterControl system is far superior to its antecedent.

7 successful years with MasterControl

Comentarios: We have been using MasterControl since 2016 and since then we have NEVER received an Audit finding (neither by our ~global customers, nor any regulatory body like DQS, district government or even FDA).I feel secure and relaxed, knowing our quality documents are in a secure, validated system that I can access from anywhere, and that they sit in a system even our customers and the regulators themselves are utilizing!As a Pharma/MedTech logistics company, an electronic QMS system is a necessity and we are looking forward to utilizing more innovations with our imminent move to the MasterControl Cloud, especially because of the very promising AQEM solution!

Puntos a favor:

Document Collaborations, Deviation/CAPA forms, training structure (Course/Exam/JobCodes/Trainee) is excellent

Puntos en contra:

Too many bugs in necessary utilities like Action Items and Extension Requests, Management of Change module not up to our quality standards, Jreports are very user unfriendly

Keep Your Business in Control with MasterControl

Comentarios: We are able to keep all of our manufacturing and quality documents under document control. Training is easier to manage and track. We can keep track of our suppliers, necessary internal and external audits, change controls, complaints, investigations, CAPAs, OOS, calibrations, etc. We use MasterControl for as much as possible and have leveraged their tools to digitize many paper processes. During audits, the MasterControl system presents very nicely.

Puntos a favor:

The seamless integration between the Documents and Training modules, and the willingness of MasterControl to listen to the users and continue improving the product.

Puntos en contra:

Performing administrative corrections (e.g. fixing typos) on approved documents can be a little challenging.

Solves problems

Comentarios: MasterControl solves a lot of problems for us but it’s difficult to sell to our employees

Puntos a favor:

QMS required training verification and retention

Puntos en contra:

The difficulty in transitioning to new upgrades.

Perfect Product for Life Sciences

Comentarios: Overall the system just works, as long as you do not try to make the system do what it wasn't intended to MC QX just works and does it the way you want it to.

Puntos a favor:

MasterControl Keeps rolling out upgrades to the system, making it better every time

Puntos en contra:

It is an expensive product and can be hard to get management buy in to use.

Flexible & Scalable Modern Quality Management System

Comentarios: Overall, MasterControl Quality Excellence has been a game-changer for our company as we grow and has helped us stay at the forefront or compliance. It has removed a lot of manual work and given us confidence in regulatory inspections.

Puntos a favor:

MasterControl Quality Excellence (Qx) gives us the flexibility as a global organization to configure what we need, as we need it, without needing to edit code or re-validate the system. It allows us to manage compliance and track documents (with revision and access control), training, and quality events. In addition the system is hosted in the cloud, so we do not need to maintain our own infrastructure or IT team solely for the software. By being in the cloud, we receive frequent quarterly upgrades with new features, monthly defect patches, and global 24/7 availability. We also utilize the VxT validation tool, which cuts our quarterly upgrade validation time down to hours, and the customer support team is top-notch.

Puntos en contra:

There are some quirks to the system that take some learning, but MasterControl has developed an excellent self-study library of courses to help. In addition, the older quality events module presented some configuration limitations that required us to adapt our processes to match MasterControl rather than the other way around. Fortunately, MasterControl's replacement of this module, Advanced Quality Event Management, just launched in 2024 and is alleviating this pain point.

Excellent Product and Customer service

Comentarios: The customer service and technical service has been excellent!! I've never worked with a friendlier or more helpful partner. The overall experience with MasterControl has been superb!!

Puntos a favor:

I like the seamless integration between the Documents and Training modules. We have totally eliminated paper training records, eliminated manual record tracking and filing, and we have ready access to all required records during audits and inspections. As FDA registered facilities we needed FDA part 11 compliance and audit trails. MasterControl has given us all these capabilities in an intuitive and easy to use paltform for all users.

Puntos en contra:

We had to do our homework when initially configuring the software to understand how to make the right decisions and allow the system to scale with our own evolution and growth. We knew where we wanted to end up, but didn't understand all the new terminology, or exactly how the system worked. We hired a third-party consultant recommended by another MasterControl user and leveraged their expertise to bridge the knowledge gap between us and MasterControl. The initial configuration took longer than we originally planned, but we ended up with a configuration that works very well for us.

Use of MasterControl

Puntos a favor:

Easy to use for end users and admins I like easy configuration of system and the flexibility

Puntos en contra:

Reporting is a little bit difficult, overview on quality tasks is difficult

Review for box

Comentarios: Fbs needs extra support. It couid help us to close our capas and QIs quicker

Puntos a favor:

Doc management js ok but the collaboration area needs improvement

Puntos en contra:

Control copy and collaboration needs more features but I know you guys will get there

Master Control Leads Competitors for price and ease of use

Comentarios: Overall, we are happy and want to grow with MC capability.

Puntos a favor:

MC is willing to continue to update and upgrade their tool.

Puntos en contra:

Attrition of Tech Support causes some inconsistencies in support.

MasterControl is a game changer for us!

Puntos a favor:

Intuitive, simple and friendly to use. Handles all of our data that we have and makes it easy to retrieve.

Puntos en contra:

I do not use it frequently enough so when I do go back and use it I have to re-learn what I need to do. Those issues come more from user than system issues.

A Decent QMS with room for Improvement

Comentarios: A Decent QMS with room for Improvement in Supplier, Audits, Risk Module, Analytics and Registrations

Puntos a favor:

Doc Management, Training and some aspects of Process module.

Puntos en contra:

Majority of the features linked to Supplier Management, Audits, Risk. User Management needs improvement. Analytics. Registrations.

Document and Training Management Improvement from Paper-Based System

Puntos a favor:

Electronic records for training and document management have allow us to move through ISO and client audits in less than half the time required prior to implementation

Puntos en contra:

Certain solution (FBS) forms are clunky and difficult to program. Initiated workflows are not readily changed to respond to structural changes within an organization.

Digitally transformed our quality processes

Puntos a favor:

The software is structured to incentive standardization.

Puntos en contra:

The software is slow sometimes and the GUI can act strangely.

All-in-one solution

Puntos a favor:

Quality events, document management or training. You find a solution for each in just one system.

Puntos en contra:

Cuncurrent license model will no longer be available.

Feedback from ADA - Bioporto

Comentarios: The system is capable of being configured in may different ways.
The BioPorto configuration is may not be ideal. but I believe that it has all the needed functionality.

Puntos a favor:

All features consolidated in one system.

Puntos en contra:

Not easy for new users to get introduced to MC. Support site and use

MC Quality Review

Comentarios: The best

Puntos a favor:

Ease of use of mastercontrol. Ability to use single sign on

Puntos en contra:

Integration is challenging especially with multiple countries and languages

Great eQMS for regulated industries.

Comentarios: Quality Excellence has been core to our culture of quality.

Puntos a favor:

Ease of use and integration with products.

Puntos en contra:

Out of the box solutions may be hard for end users to adopt.

Review of MasterControl Quality Excellence

Comentarios: Good. However, some terminology can be difficult to understand.

Puntos a favor:

Once set up it was easy to use. The workflows are set up very well that the documents always route correctly.

Puntos en contra:

FBS system very hard to set up A lot of built in templates e.g. NCR, Dev, CAPA etc does not suit all business needs. Cannot customize unless have AQEM

MasterControl Qx is a great tool for compliance in documents management

Puntos a favor:

Integration into other hubs in MasterControl

Puntos en contra:

Some of the confirmations can have better data sharing and reporting.