MasterControl Products

The MasterControl™ GxP process management suite consists of configurable, easy-to-use, and connected applications for automating, streamlining, and effectively managing GxP processes throughout the entire product development process from conception to commercialization. Hundreds of companies worldwide rely on MasterControl to facilitate compliance with FDA, and other worldwide regulatory bodies (e.g., GxPs, 21 CFR Parts 11, 210-211, 820, 606), and ISO quality standards (e.g., ISO 9000, ISO 13485, ISO 14000, ISO/TS16949) to improve product quality and safety - and to ensure compliance.

MasterControl Applications:

MasterControl Audit™

MasterControl Audit enables companies to better manage their entire audit process — from planning audits and capturing findings to conducting CAPAs and creating final audit reports. The solution connects the audit process with the rest of the quality system for a comprehensive approach to quality management.

MasterControl Bill of Materials™

MasterControl Bill of Materials streamlines the handling of BOMs and helps companies overcome common BOM-related predicaments.

MasterControl Documents™

MasterControl Documents helps increase the quality unit's efficiency and effectiveness by automating task assignment/routing, scheduling, follow-up, tracking, escalation, review, and approval of all documents-based processes. It provides a single repository for all documentation, making search and retrieval easy. MasterControl Documents, the core application in the MasterControl quality management suite, integrates all quality processes such as change control, customer complaints, corrective/preventive action, audits, etc., for a closed-loop solution.

MasterControl Registrations for eCTD™

MasterControl Registrations for eCTD , a product registration and eCTD management solution for pharmaceutical and biotechnology companies, allows tracking of all requirements for every geographic location where a product is being registered. It streamlines content generation and management in preparation for electronic submission publishing via a partner or in-house publishing tool.

MasterControl eTMF™

MasterControl eTMF Manager helps companies effectively manage electronic trial master file (eTMF) processes and integrate them with other quality processes critical to regulatory compliance. It is based on the standardized DIA (Drug Information Association) TMF Reference Model that is designed to enable real-time visibility into the status of all activities pertaining to a clinical study. It provides an industry best practice approach to TMF document management that increases your visibility into the status of all the required, outstanding, and in-process items in your TMF.

MasterControl GLP Studies™

MasterControl Studies enables companies in FDA environments to better manage quality information related to their GLP and GCP studies. The solution adds a number of key features to MasterControl's already-robust functionality, including: management of studies; study aspects, phases and protocols; analytics reporting; and more.

MasterControl Process™

MasterControl Process automates routing, notification, escalation, and approval of any forms-based process for faster turnaround. This solution offers best-practice features that prompt users with selected data to reduce data entry and avoid mistakes common in manual data entry. Forms created in Microsoft Word, Excel, or PowerPoint can be converted to PDF as is, so users will see the same form and won't need new training. A company may also improve existing forms or design new ones to suit its needs.

MasterControl Registrations 510(k)™

MasterControl Registrations 510(k) , a dossier management and product registration solution for medical device companies, provides project visibility by region and product. For each device, users will readily see all geographic locations where the product is being registered and the corresponding requirements. Inversely, users will easily see all products and corresponding artifacts that are up for approval or re-registration in every geographic location./p>

MasterControl Risk™

MasterControl Risk unifies all risk-related activities and documentation in a single, centralized repository, providing an accurate picture of the risk landscape across product lines, business processes and business units. The solution's robust features provide insight into, and easy access to, risk assessment and mitigation activities.

MasterControl QMS Suite Overview™

The MasterControl quality management software (QMS) suite offers regulated organizations of all sizes the most complete choice of integrated quality and compliance solutions. Built on a centralized Web-based platform, the suite consists of configurable, easy-to-use applications that automate, streamline and connect all quality processes for a holistic approach to quality management.

MasterControl Spark™

MasterControl Spark is a hosted product package specifically designed to meet the unique needs of small, growing regulated businesses — delivering the same world-class MasterControl software used by enterprise-size organizations but at a lower cost. Spark requires minimal IT resources and comes complete with an education, services and implementation offering.

MasterControl Supplier™

MasterControl Supplier provides a solution for collecting, organizing, and reviewing all the documents required to meet the GCP requirements.

MasterControl Training™

MasterControl Training automates assignment and monitoring of training tasks and grading of online exams. It allows sequencing of training courses, so after a prerequisite course is completed, the next one is automatically launched. Provides group sign-off feature for verifying training of large groups of employees. Training management can be integrated with the rest of the quality system, so any change to a document or process that warrants new training will automatically invoke training tasks upon approval of the change.