MasterControl Quality Excellence

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.

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.

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).

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.

Kneat, Microsoft 365, Aras PLM

We use MasterControl Quality Excellence to capture quality events that occur and oversee the process from opening to closing. The business problems it solves is to have full traceability and audit trail when opening and closing these events. We also want to have all the process enclosed in one eQMS and have the different events be interlinked.

Greenlight Guru