MasterControl Manufacturing Excellence

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.