MasterControl Manufacturing Excellence Erfahrungen

Vorteile

MasterControl's Mx solution is embedded with quality throughout the entire platform and process. Mx does not just document completion of executed steps during the manufacturing process. It allows you to easily configure defined parameters and what happens when entered values exceed these limits. The Review by Exception tool allows quality assurance reviewers to focus on specific key areas of the batch record rather than completing a line-by-line review due to these configurable controls. In addition, the product is integrated with the quality solutions of MasterControl, including documents, training, and quality events. For example, the system performs training checks to prevent users from working on a batch record if their training is not complete (there is an option for a supervisor override), and deviations can be launched and linked from the batch record with the quality event status clearly visible to batch reviewers. Lastly, we like how easy the software is to use; we are able to configure it ourselves without needing ongoing consultants.

Nachteile

There are some minor software limitations, for example you cannot correct or change a lot number after a batch record is created. There are also some features, such as global elements, that cannot be used in conjunction with other features, such as product families. Once you learn these limitations, you are able to develop workarounds for them.

Vorteile

MasterControl's Manufacturing Excellence is changing the way we work, asserting more control and compliance in our manufacturing workflows, simplifying data entries and corrections for people on the floor, and dramatically improving the review process. We've implemented a fraction of our Manufacturing procedures so far, but the 'pull' from the Manufacturing department is impressive. They're really positive about the system and are working fast and hard to implement all of our paper-based procedures in MasterControl as quickly as possible.I should mention that 'Manufacturing' in our case encompasses all of our Quality Control procedures as well. The QC department has been a leader in transitioning testing procedures to Mx, and as such, our testing procedures mesh seamlessly with our manufacturing procedures to create fulsome, integrated production records that can be QA-reviewed all together.

Nachteile

At present our nonconformance procedures are outside of MasterControl, and therefore any nonconformances are executed on paper and are then scanned into the Mx production records. This is on us. Once we've implemented the nonconformance Advanced Forms in Qx, things will work seamlessly.

In Betracht gezogene Alternativen

Gründe für den Wechsel zu MasterControl Manufacturing Excellence

Vorteile

The ability to enforce training dependancies in Production Records to ensure end users are properly trained before executing Phase Steps is critical for day to day operation here at BioSpectra. The different utilities within each different Phase Step Type gives the Template Builder a wide range of formatting options, which is essential for building a Template that is clear and concise, functional, and easy to execute once a record is issued from it.

Nachteile

We have experienced quite a few issues while attempting to import or export any Master Templates between the different environments (Dev, Test, & Live Sites). Being in the Pharmaceutical environment, we have come across a few instances where we have identified defects in the system that have been critical for us but low priority on MasterControl's side as they are not a regulated company.

Vorteile

I like the overeall interface of master control and the ease of use for my staff.

Nachteile

Master control is more costly than other eQMS systems and it is a bit difficult to obtain 1:1 technical help when issues require troubleshooting

In Betracht gezogene Alternativen

Warum MasterControl Manufacturing Excellence gewählt wurde

Gründe für den Wechsel zu MasterControl Manufacturing Excellence

Vorteile

I love the form builder and the JR Reports/Insights. More of the form builder so we can build our our quality and system access forms.

Nachteile

Even though I love the form builder, the template is really hard to use and there is so much limit to what can be added to the forms. And with a longer eForm being made and continuously updating, the JR Report for it keeps breaking.

Vorteile

I love the ease of building production records and the integration between Mx and Qx.

Nachteile

I think the flexibility of data entry corrections after a record is launched can be improved.

In Betracht gezogene Alternativen

Warum MasterControl Manufacturing Excellence gewählt wurde

Gründe für den Wechsel zu MasterControl Manufacturing Excellence

Vorteile

I find the Master Template Builder tool to be relatively easy to use. The interface is user-friendly and functionalities make sense.

Nachteile

For Master Template building, our team has found that some restrictions are difficult to find work-arounds for. For example, if an Operation level is configured to be 'Repeatable', if any calculated values are within that repeated Operation, those same values cannot be pulled to other parts of the record. This is limiting when data propagates throughout an entire record. I have trained the Builders to instruct 'transcribing values' from repeatable Operations to be able to be used later downstream.

Vorteile

Mx has been very user friendly for all aspects and parties involved. Implementation was very hands on and user friendly. Both our builders and operators were able to learn quickly

Nachteile

Still a newer product so some limitations

Vorteile

User friendly and very intuitive. Flexibility of templates and additional features make revisions easy and quickly issued.

Nachteile

Could use a better revision history module to capture the template revisions inside the system.

Vorteile

It is extremely easy to both create master templates and complete production records.

Nachteile

Taking time to get improvements that I find valuable.

Vorteile

We have been a Master Control customer since 2007. The system has streamlined our document control process. The ability of the system to connect all the different modules makes it easier for us as a Medical Device regulated to comply to regulations.

Our users complement how user friendly the system is and how customizable it is in terms of searching for document based on metadata or by drag and drop.

The use of the form builder tool allowed us to moved several paper based process to electronic. The forms are easy to build and lets you customize it as needed.

Their tech support staff is friendly and very knowledgeable and if they don't know the answer to something they get back to you in a timely manner.

Nachteile

There is room for improvement in reporting. Master Control has already identified this gap and planned to include in future releases.

Vorteile

MasterControl MES has provided my company with a great resource to make our entire process more lean. The savings we have had as a company just from moving away from paper records is worthwhile enough, but the modular nature and no-code simplicity of the interface has allowed us simplify all of our records in a way that was easy to implement. Also, the interface with our quality system was seamless and API integrations are something we are looking forward to putting in place. MasterControl is also constantly improving their software to provide more and more functionality to its end users and the customer service experience has been excellent

Nachteile

Integrating with regulatory, validation of templates, and some small lags are the main issues or services that we have not taken advantage of yet.

Vorteile

I did not participate in the configuration. However, I have used the Production Record Solution to issue electronic batch records.

Nachteile

I do not like the search function. It can be challenging to search for a completed production record. Some of the fields have too many options for completed records.

Vorteile

linking sections within product records (data protection). Wide range of parameter options when creating sections.

Nachteile

It can be quite rigid in some areas. Reporting is complex. No back button or history section. unable to change/ replace one item in multiple places at once, you have to find the issue in each step/ section and change individually which can be very long winded especially as you can not search for specific data/ codes.

Vorteile

Ease of use. I was able to quickly figure out how to create a Master Template and a Production Record by following the handouts from MasterControl.

Nachteile

There is no view only capability of production records that are "in-progress". There are functions outside of the Manufacturing Team who rely on real-time data from the production record to set up testing of samples. Because there is no view only of in-progress eBRs, this necessitates work arounds which adds work. The system requires that a User assigned to an Mx Operator Basic to also have a Basic Qx License. This interdependancy should be de-coupled as a User may require to perform full license rights in the Qx module but only Basic operator functions in Mx. I am a system administrator and there are no sys admin manuals or design specs or anything similar to the Documents and Process modules to help with administering the system. As a result, I am learning what is required as use errors occur. For example, how would an Admin know that the Trainee Infocard needs to be released before the User can work in Mx?

Vorteile

TraceabilityQualityLinking trainingInstructions right at n operators fingertipsQuick containment when issues arise

Nachteile

Lag loading times. Glitches during first few weeks of updates. Technical support takes a while to fix issues.

Vorteile

Batch records, some features more customizable than others. The basic stuff is good once you get the hang of it. I love this and the company has been quick to adapt, demonstrates the ease of use.

Nachteile

Customized reports are difficult. There is opportunity for some awesome reports, but very difficult. Integration with our ERP has been more difficult. Understanding of what the roles mean and how they are used lead to confusion and now have to pay more later b/c we did not fully understand what we needed.

Vorteile

Ease of conffiguration and use of product

Nachteile

Lack of integration which is key in reducing the number of templates

Vorteile

Ease of use, user configurable, connection between their modules and the ability to create form workflows.

Nachteile

The need to upgrade to address bug fixes, having to upgrade to incorporate new features, User Training and validation time.

Vorteile

Ease of use and flexibility. Helps our manufacturing team become paperless

Nachteile

Difficulty in configuration requires a lot of knowledge of MasterControl.

Vorteile

This makes track products from R&D through full production so sinple

Nachteile

A few less documents would be nice to not have to pass through.

Vorteile

User friendly, fairly intuitive great customer service

Nachteile

Hate the current form builder and template design.

Vorteile

Ease of building Master Template to completely capture our process/EBR

Nachteile

API/Integration need to capture all the necessary data points of auxiliary systems.

Vorteile

Al company data on one system and different options on modules

Nachteile

Tools for trainings, NCMR, Capas, and analytical reports.