We use use MasterControl Manufacturing Excellence to record our device history record for our medical device manufacturing company. The product allows us to record device history, record information for FDA and ISO compliance.
Pros
Configurability
Product support
New features and functionality
Cons
Insights reporting
Revision of production records with product families
Transfer of metadata to launched forms
Likelihood to Recommend
The solution is well suited for anybody in a regulated industry that has compliance in mind. Additionally, if you want a dynamics solution that will meet your changing needs as an organization. The solution may be too much for a smaller organization.
We use MasterControl Manufacturing Excellence to issue batch records for multiple product lines. We previously used paper records for this process. Switching to electronic has helped us greatly. Our batch record issuance time has been drastically reduced so we can get our manufacturing teams the documentation they need as fast as possible. This has increased the visibility all appropriate employees have regarding the batch records. Previously we would need to find the specific printed record (sometimes in offsite storage) and dig through to find what we needed. Now any user can search the database to find the record they need and gather any data without having delays reaching out to other departments to dig through the data. Putting limits on specific data entries ensures accuracy of information by preventing users from accidentally inputting nonsense data into the record.
Pros
Visibility of data
User friendly
Efficiency
Cons
Creating new templates can be cumbersome
Re-issuing into a new template version can be time consuming
The default views are not useful
Likelihood to Recommend
MasterControl Manufacturing Excellence is excellent for creating batch records to track a specific regulated process. It helps us keep our data in line and make sure we are following our procedures.
there are some difficulties with more customizable products. The more variable that are in the product the fewer features that MasterControl Manufacturing Excellence can apply to assist
We use it to turn our paper record to electronic specially electronic batch record we use it for. Some problems are just how long it takes to create electronic batch records since your paper records are very long and detailed. We also are having issues getting every one in the company on board
Pros
No coding
Easy to use
Appealing
Cons
Takes long to create ebrs
Some people are resistant
Only one person at a time can do it
Likelihood to Recommend
It is good for use because we are running out room to store records so moving on c rything electronic will really help us stream line and efficient in the batch record department. It is taking us a long time to create the electronic batch records but we will get there
Our organization uses MasterControl Manufacturing Excellence for production electronic batch records and electronic logbooks. Our main goal is to reduce errors and deviation generation. Through the implementation of MasterControl Manufacturing Excellence we have seen an improvement of these reductions in a small amount of time. Our operators are truly enjoying the ease of use of the system and how dynamic the system is when executing the records!
Pros
Customer service
Master template building
Troubleshooting
Cons
User Interface
Executabulity of certain phase steps
Additional parameters implemented to steps
Likelihood to Recommend
MasterControl Manufacturing Excellence is well suited for production floor execution. Templates are easy to create and organize for ease of use by the operator. I believe this product is well suited for any type of manufacturing line production where operators need to document their actions. It is configurable to any and probably all industries.
Currently we are trying to roll out the module to bring our manufacturing department ip to speed making user errors lesson. This will help with any paperwork and compliance issues that are being open.
Pros
Routing for correct approvals
Keeping record within the correct guidelines
Keeping all managing under one umbrella
Cons
Routing could be done better less confusing
Opening up under the QX module instead of having to go to a different hub
having quick approve be harder to use
Likelihood to Recommend
Manufacturing has been amazing for batch records within the company seemless ways for things to push through not missing any requirements within MasterControl Manufacturing Excellence as it won’t let you move forward or sign off
MasterControl Manufacturing Excellence reduces human error and the amount of paper necessary to complete a batch record, making quality review much simpler.
Pros
Tracks approvals
requires training to be completed
Cons
Building could be simplified with more user friendly features
Likelihood to Recommend
MasterControl Manufacturing Excellence is best suited for companies that frequently use batch records and have similar products with small differences in the process to consolidate records
We use MasterControl to get paper out of the cleanrooms and have better visibility into our processes. The manufacturing insights help us track productivity and issues in our processes to identify negative trends. MasterControl Manufacturing Excellence also helps QA review with review by exception and live notifications whenever a deviation occurs or out of specification limit is reached.
Pros
Limit notifications
Review by exception
Operator traceability
Cons
There have been some incidents where one operator filled out information on a batch record under another operators profile due to their account being open during processing.
Reporting for tables to correlate actions with reactions
Bill of materials and material traceability
Likelihood to Recommend
The MasterControl Manufacturing Excellence is well suited for processing inside cleanrooms. MasterControl Manufacturing Excellence is also good at complex calculations. Specifically, calculating large numbers cells for cell therapy to determine seeding density, population doubling levels, and final formulation. MasterControl Manufacturing Excellence is not suited for material management or distribution management.
We use MasterControl Manufacturing Excellence for our electronic batch record system. It manages production and maintain traceability throughout the manufacturing process. We initally rolled it out for a few product lines and saw immediate improvement over paper batch records.
Pros
Decent template builder functionality that is easy to learn
Smooth experience for manufacturing operators
Good technical support team
Cons
Improvements are a bit slow, and sometimes issues are introduced
The template builder is not able to handle more complex processes
Will need integrations to build out a full MES solution
Likelihood to Recommend
<div>It is good for batch processing that is complex. It shines in regulated industries.</div><div>It may be to complex and rigorous for small manufacturing businesses, or high volume discrete manufacturing.</div>
we use MasterControl Manufacturing Excellence for production batch records to help us in eliminate paper base batch records, reduce the risk of losing documents
Pros
Review by exception
EBR
Able to integrate with other company’s systems.
Insight
AI
Cons
Attachments are not included in downloaded eBRs
Likelihood to Recommend
MasterControl Manufacturing Excellence is very easy to use. And documented in real time.
VU
Verified User
Manager in Quality Assurance (1001-5000 employees)
MasterControl Manufacturing Excellence has been a great tool in being able to easily create trainings for our team and to be able to compile reports of that training into one place. This has helped us to minimize the number of employees who are missing training for their jobs and has also helped us to increase the information retained through trainings. We have over 500 employees at our site and this has been useful in storing all their information.
MasterControl Manufacturing Excellence has also allowed us an easy place to create work instruction documents and standard operating procedures; it also allows us to keep these stored in an easily accessible manner.
Pros
It is easy to create reports for trainings or other information needed
Creating documents within MasterControl Manufacturing Excellence is also intuitive and easy to do
creating training tasks is also something that MasterControl Manufacturing Excellence is able to handle well
Cons
Collaboration within a document on MasterControl Manufacturing Excellence could be improved
I would like to be able to put more than 1 prerequisite on a training task in MasterControl Manufacturing Excellence
It would be nice if training aids from MasterControl Manufacturing Excellence were accessible within the application and not just their site.
Likelihood to Recommend
As I stated before it has been great for training purposes, being able to easily see what training tasks are missing from employees' accounts and being able to create training when there are gaps in the curriculum has been a life saver.
I do wish it was easier to pull up some of the information on individuals though, at times it is difficult to filter down what you need from the unwanted information that is included in some of the reports.