MasterControl Quality Excellence

MasterControl is my one-stop shop for an electronic quality management system. The software can handle all aspects of the life sciences and can tackle just about any situation that arises. We were able to incorporate other MasterControl modules to meet our demands, but the main module used is the Quality Excellence (Qx) module. The Quality Excellence module has been able to adapt to the company's needs and continues to evolve in response to future needs.

• MasterControl Quality Excellence has been able to shorten the time needed to complete document reviews as the options to alert users are abundant.
• MasterControl becomes the center hub for the business as everything needs to be funneled through the EQMS. Therefore, new users understand the importance of utilizing the system.
• The ROI has been difficult to see for stakeholders who do not use the system often or at all. This value is not readily visible to users who do not use the system.

QAD Adaptive ERP, Oracle Access Management and SAP Access Control

Our organization used MasterControl Quality Excellence as a document management and quality event handling system. MasterControl Quality Excellence addresses the problem are managing large amounts of documents efficiently and in a controlled manner. It really helped us get off a paper based system. AQEM has allow us to make a customized event handling work flow that provides all the features needed for design.

• It’s positively impacted us by allowing the company to collaborate cross functionally from different locations

The MasterControl Quality Excellence platform addresses our problems by complying with 21CFR part 11 and improving productivity by switching all of our paper processes to electronic. MasterControl Quality Excellence also allows greater visibility into the productivity of our users and notifies them whenever a training is due or a task is assigned to them.

• Faster document processing
• Increased visibility into productivity
• Increased productivity amongst users

MasterControl is Aldevron’s

eQMS, which encompasses various components that support compliance. The primary uses for the system are:

Documentation storage.

Non-executed templates and executed versions of documents are stored

within the system and used for initiating,

approving, and storing quality items within the process and AQEM modules, such as Quality Events/Deviations, Out of Specification (OOS) items, Invalids, CAPAs (Corrective and Preventive Actions), and Change Controls. Aldevron’s training management system captures copies of physical training documents as well as electronic training documents (such as read and understood training for SOP reading).

• Less time locating documents.
• Training module is great for record keeping.
• Reporting could be improved.
• Having personal support is highly needed.

AssurX and Biovia

LabVantage

We use Quality Excellence for documents and training across multiple manufacturing sites for our organization. MasterControl has helped us reduce the amount of places documents are kept and keeps training compliance at the forefront. Before MasterControl are documents in training were not all electronic and not harmonized across locations.

• We have been able to whittle down the number of databases that our documents are kept in from well over 50 to a single location in MasterControl.
• We've been able to convert paper training records into electronic training records when using MasterControl, which is saved a lot of time on the production floor keeping track of training.
• By having the same tool and format across multiple places in the business it has helped the organization become more efficient.

Kneat, Microsoft 365, Aras PLM