The MasterControl™ quality management suite offers an integrated approach to meeting FDA regulations and ISO
standards. It consists of the following configurable, easy-to-use, and off-the-shelf products that effectively interconnect
data, processes, and people to maintain compliance and promote efficiency throughout an organization:
■ MasterControl Portal™ – a 100 percent Web-based delivery platform for the entire MasterControl
quality suite. It’s especially critical for companies with FDA 21 CFR Part 11 requirements for electronic
records and signatures.
■ MasterControl Documents™ – The essential building block within the MasterControl suite, this software
manages and controls documents in a secure environment. It can handle all types of documents regardless of
the software used to create them. Document types, vaults, lifecycles, routes, and users’ roles are all configurable.
Q&A: Pharmaceutical CGMPs for the 21st Century: A Risk-Based Approach
■ MasterControl Submissions™ – This application provides complete document lifecycle management from
document creation and control to submission and beyond. It streamlines the dossier-creation process with
ready-to-use templates authorized for FDA submissions, such as new drug application (NDA), biologic licensing
application (BLA), common technical document (CTD), and investigational new drug (IND).
■ MasterControl Forms™ – This module automates forms-based processes, such as audits, nonconformances,
deviations, and customer complaints. It makes the transition from a manual/hybrid system to an automated
solution easier because it allows users to create electronic forms identical to their existing hard-copy forms.
Companies can also design new forms to suit their needs.
■ MasterControl CAPA™ – Closely related to the Forms module, this application is designed to make
implementation of corrective/preventive actions (CAPA) efficiently and effectively. It collects data from
multiple sources, manages trends, connects and automatically triggers sub-system processes to solve
production issues.
■ MasterControl Training™ – This software allows the creation and deployment of simple or extensive
training courses that require trainees to learn their tasks and demonstrate competency. It seamlessly integrates
with MasterControl Documents to automatically task trainees when required SOPs or other documents change
as a new training becomes necessary.
■ MasterControl Collaboration™ – Its Internet-based architecture connects employees and departments –
regardless of location – to make it easier to share ideas, improve document content, and obtain approval and
sign-off. Tasks are automatically sent to all affected users, accompanied by e-mail notification. Everyone in the
collaboration group gets to see each other’s input, avoiding duplication.
■ MasterControl PDF Publishing™ – With this module, a company can put a stop to unauthorized
circulation of printed and electronic “rogue” documents. It preserves record authenticity, enhances security,
and improves compliance by restricting users’ rights to copy or revise documents.
