MasterControl Manufacturing Excellence Reviews

Pros

ease of use with template builder and deployment within our manufacturing environment

Cons

integration still needs improvement in flexibility and features

Pros

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.

Cons

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.

Alternatives Considered

Reasons for Switching to MasterControl Manufacturing Excellence

Pros

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.

Cons

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.

Pros

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

Cons

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

Alternatives Considered

Reasons for Choosing MasterControl Manufacturing Excellence

Switched From

Reasons for Switching to MasterControl Manufacturing Excellence

Pros

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.

Cons

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.

Pros

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

Cons

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

Pros

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

Cons

Too much release per year, user experience with big template

Pros

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

Cons

Cumbersome drafting of templates. Have no to configure each step

Pros

I liked organization of documents the most.

Cons

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

Pros

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

Cons

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

Pros

TraceabilityQualityLinking trainingInstructions right at n operators fingertipsQuick containment when issues arise

Cons

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

Pros

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

Cons

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

Pros

Ease of use and multiple access options.

Cons

The role out at our site. Not MCs fault.

Pros

This product is ensuring equipment stays calibrated per schedule. This ensures compliance.

Cons

Ok, it’s expensive. But after the expense, it still delivers the ROI. So it’s worth it.

Pros

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

Cons

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

Pros

Al company data on one system and different options on modules

Cons

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

Pros

I love how each step that is filled in captures the exact date and time the step happened. It’s brilliant for traceability and makes our data so much more accurate.

Cons

If it could link to Insights that would be perfect

Pros

The ability to link calculation blocks together to drop information from previously filled out boxes is very useful. It makes sampling easier in that sense because we only have to link the calculation once, and it will automatically populate for us.

Cons

As a nonGMP lab, the major con is how rigid the MasterControl structure is. Our operations change on the fly, and we cannot account for that given the fact that MasterControl was intended for GMP labs in the first place. This is our major holdup, and we won't be able to implement the system further until it can be more flexible.

Pros

It is amazing to be able to have batch records transitioned from paper to electronic.The error rate has declined significantly so the time it takes from production to release of the product has increased which is a plus for the business!

Cons

The learning curve for myself was a bit longer than I expected but once I figured out what I was doing it is fantastic.

Pros

Helped us reducing human error, saving time in our QC review and delete duplicate data entry

Cons

Can’t do real Time interfacing with ERP on complex scénario

Pros

Easy to use, user friendly. Paperless, efficient

Cons

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

Pros

1. Culture change where site is now doing paperless and getting comfortable with systems in general

Cons

1. It’s fairly new so a lot of kinks needs to be removed. Need to ensure it is scalable

Pros

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

Cons

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

Pros

I like that it is a great way to control documents and their revision history. Great collaboration tools for new documents.

Cons

Needs better reporting and searching abilities

Pros

Offers a lot of different features and solutions

Cons

Took awhile to set up and need a team to implement