MasterControl Manufacturing Excellence

Vorteile

It gave the customer full control and customization of the workflow, rather than defining it for us.

Nachteile

The time it took to receive enhancements.

Vorteile

It is super intuitive for setting up the batch record templates. It takes little to no computer expertise to complete the batch records. It is a great tool!

Nachteile

The only drawback is the additional costs for licensing.

In Betracht gezogene Alternativen

Gründe für den Wechsel zu MasterControl Manufacturing Excellence

Vorteile

-Integration of Quality Documents
-Removal of paper from the production floor.
-Accountability of who enters data in production

Nachteile

-Customer Support is slow and usually can't go anything. They just blame the product design and say the product is working as designed.
-Software is extremely slow for operators to use
-Software is full of bugs that make building and using templates difficult
-Feature called "Product Families" is poorly designed and is not usable with most of the other functions in the module.
-Building templates is slow and cumbersome and lacks basic features like copy/paste for more than one item at a time.
-Barcode scanning functions are too basic to be used effectively in a manufacturing environment.
-Product managers assigned to launching Mx do little to nothing to support you.
-UI is not well designed for a production environment when operators are wearing gloves and PPE. Text is small and most of the UI cannot be customized for individual needs.

Vorteile

The ability to use system features to prevent human error from occurring. It is also nice to configure records to notify users via email when certain steps are completed (i.e. failing result, OOS result).

Nachteile

Lack of reporting capabilities. With implementation of premium insights module we can now create and manage dashboards of all of our data from MX Module, including KPI, CPP, Corrections and more.

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

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

The Mx configuration is very flexible and can be easily adapt to our company processes. Also the development of new features are in good speed, I see new things coming up quickly and very useful.

Nachteile

Since our company run production 24 hours a day, the stable performance is really the key. But the Mx sometimes get interrupted either by large reports or serve get hiccups, especially when updates been installed.

Vorteile

Ease of use for end users - able to learn the system quickly and start using within a few hours

Nachteile

Enhancements and defects sometimes take too long to be implemented.

Vorteile

How it links in with other MC programs and makes tracking soooo much easier.

Nachteile

The start up and building take a bit of time (but once set up it is all good)

Vorteile

It's a user friendly, easy and simple to maneuver around the topic.

Nachteile

I didn't have anything that I like. I like everything the service offer.

Vorteile

The product is easy to understand and use. I like the straightforward UI and how all options are presented clearly.

Nachteile

The most difficult feature to use in Manufacturing Excellence is currently product families. It is tedious to modify steps that already have the product family setting applied. Additionally, I would like to see better word wrap settings instead of the horizontal scroll bar on the list of product families below the step in order to better see the settings applied.

Vorteile

Ease of use and multiple access options.

Nachteile

The role out at our site. Not MCs fault.

Vorteile

It provides a digital format for documenting production activities. This allows for a reduction in human errors specifically in documentation, as well as the ability to easily collect and analyze data about the manufacturing process.

Nachteile

The largest friction point that we have with MX is a lack of customizability. Our process is very complex and we have found ourselves having to make multi-step workarounds in order to replicate our process.

Vorteile

Helps the client relations team reduce paperwork and easy to locate their documents in the system.

Nachteile

I would say Guest Connect for outside users to sign documents in the system from Adobe to MasterControl.

Vorteile

Ability to custom build your solution to meet your process. Easy to pick up and master. Very fluid.

Nachteile

If you prefer and out of the box solution and not willing to customize, you may experience challenges.

Vorteile

Once you make a template, you can easily change anything you want. It is very good for traceability

Nachteile

You can't go back to the previous version of MX

Vorteile

Just learning the building of it working on it now

Nachteile

Just learning and building it out to work for operators

Vorteile

We are a startup company and we did not have previously written batch records to integrate into Mx. We are building ours within the solution from the ground up. It is very simple and easy to build in the required controls as well as integrate with other solutions/modules within MasterControl such as Documents, Process, etc.

Nachteile

We have not currently encountered any issues or needs that are not met.

Vorteile

the simplicity of the software but the fact it provides so much fucntionality

Nachteile

As a business we havent seen any negative so far...

Vorteile

Features like calucalation of time, weights, enforcing numeric digits, warning when out of specification.

Nachteile

Not allow pictures s and being able to do basic text formatting at phse steps.

Vorteile

Easy to use, user friendly. Paperless, efficient

Nachteile

Not really bad to share, unless basic user not needed.

Vorteile

Master Control is a very organized, intuitive, robust, and user friendly system

Nachteile

Master Control can have problems connecting to other systems such as MES.

Vorteile

Robustness. The robustness and complexity help the manufacturing process run smoother.

Nachteile

Not intuitive and user-friendly. The system is complex and require substantial training in order to be able to use it effectively and efficiently.

Vorteile

The interface is intuitive, ensuring a smooth user experience. Collaborative features enhance team efficiency.

Nachteile

Initial learning curve, but support team is helpful. Customization might be overwhelming for beginners.

Vorteile

Fantastic tool for final qc processes, and extremely easy to setup. Looking forward to the additional functionalities with insights, particularly with SPC trending. I would hope this can all be automated without having to set up individual dashboards/reports for all values to be monitored.

Nachteile

Integration with SAP has been very difficult. Most of the difficulty has been on our side, but the time difference with being in Germany and only having integration support in Salt Lake City is not ideal. We only have a few hours of potential overlap, making ad hoc meetings nearly impossible and leading to unnecessary delays.

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 is an excellent choice for companies in highly regulated industries looking to improve their manufacturing processes and ensure compliance. While it can be complex and expensive, the benefits of automation, document control, and regulatory tracking make it a valuable tool for large organizations.

Nachteile

Although the support team is knowledgeable, some users have reported slower response times during peak periods. This can pose a challenge when urgent issues arise.

Vorteile

ability to link controlled documents , prevent an untrained user to complete a step in Production records
Review by exception

Nachteile

quest user access
Builder licenses are really expensive
running VoD creates a report using MT number which is only visible in pilot vault. looks like discontinuation of numbering in the Production Vault

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 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

Easy to use, no code, schelable, and nice road map orientation

Nachteile

Too much release per year, user experience with big template

Vorteile

The adaptability of the platform. Development of workflows to suite end users. Continuous improvements with quarterly upgrades.

Nachteile

Cumbersome drafting of templates. Have no to configure each step

Vorteile

Issuing batch records is extremely simple. Lot number control ensures numbers aren't skipped and the ability to filter records between various products is extremely useful. Mx Builder is user friendly and intuitive to use. Regex expressions allow you to define user inputs, decreasing entry errors.

Nachteile

Reporting and data analysis is a bit challenging. Insights is an improvement from Jreports, however, there is still quite a learning curve before the module becomes useful. More training and improvements to the speed/functionality of Insights would greatly improve the product.

Vorteile

We use this product to maintain our production in our subsidiary, and not many other companies offer this feature.

Nachteile

The cost of licensure limits how many people can make and use the eBR.

Vorteile

I like the flexibility to build an electronic batch around our process. In the past I've seen process changes occur in order to facilitate lack of software configurability which is a concern. The flexibility of MasterControl eliminates that concern.

Nachteile

Fully integrating MasterControl with an established ERP such as SAP is a little more difficult than it first seemed. We have quite intricate batch records with a large amount of differing components. MasterControl has been open and helpful during this process, but there have been many bumps in the road.

Vorteile

I liked organization of documents the most.

Nachteile

I like the least is the lack of connectivity between records.

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

The change control process is great, so is the search function. E batch records are very useful for the one process we used

Nachteile

Our instance was set up by an internal team that should not have been in charge of that task. As a result our instance ended up feeling clunky and unintuitive.

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

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

a lot of features
continuous improvement
Production record section - easy to build a new record.

Nachteile

Enhanced search - not being able to open a title in a new tap, unable to expand a section to make it readable.
After a certain period of time you are kicked out of the program

Vorteile

Document Control traceability is very good.

Nachteile

Customization and ability to speak to other systems.

Vorteile

Time saved in batch review along with the cost and the ability to link quality events

Nachteile

So far nothing .. but perhaps when revision a template can’t use it for a short time

Vorteile

User friendly, fairly intuitive great customer service

Nachteile

Hate the current form builder and template design.

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

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

The infocard feature that allows you to check previous history, status, revisions, upload attachments, and adding links to documents.

Nachteile

Constantly logs out of my account, frequently doesn't save or capture changes in collaboration workspace, frequently doesn't allow or there is an error when opening documents in collaboration, lag time to search for documents, occasionally will have to click "discard" or "replace" the infocard when revising documents in the collaboration workspace, and searching for document # and sometimes doesn't show up unless you click "expand search" to find the document.

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 building Master Template to completely capture our process/EBR

Nachteile

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