News - GxP Process Management Software

MasterControl™ Announces Release of MasterControl Version 6.1 GxP Process Management Solutions for Life Sciences

SALT LAKE CITY - July 25, 2007 - MasterControl Inc., the leading provider of GxP process and document management software solutions for the life science industry, today announced the availability of MasterControl Version 6.1™, expanding the company’s offerings with the introduction of eleven new modules.

“This release is all about delivering unique functionality tailored for the unique life science companies,” says Brian Curran, senior vice president of strategic marketing and product management. “MasterControl 6.1 illustrates our commitment to delivering solutions that each life sciences customer will value, whether they are in the pharmaceutical, biotech, medical device, blood, or biologics industries.”

The following new solutions will appeal to companies in the pharmaceutical and biotech arenas:

  • MasterControl GCPDocs Spark™  is a preconfigured, easy-to-validate document management system for small pharmaceutical and biotech companies that can be hosted for a low monthly subscription fee.  The system is used for collecting, organizing, reviewing, and approving all the documents necessary to meet Good Clinical Practice (GCP) requirements. 
  • MasterControl GCPDocs JumpStart™  is an affordable, hosted solution for young companies who want to automate their document control process.  This out-of-the-box solution is specifically designed according to industry best practices to help organize and control clinical, non-clinical, and regulatory documents to meet NDA document management needs for growing pharmaceutical and biotechnology companies.
  • MasterControl CAPA Pharma™  is a complete solution designed for pharmaceutical companies who need to integrate multiple quality processes with CAPA.  MasterControl CAPA Pharma automates routing, delivery, escalation and approval of CAPAs and all related documents in a centralized repository.
  • MasterControl Customer Complaint Pharma™ automates complaint handling, connecting it with the quality control system, providing links to corrective/preventive action (CAPA) and handling adverse events.  Connectivity helps managers track a complaint from initiation to completion for faster complaint resolution and indicates trends, if present.
  • MasterControl Projects connects the project plan to assigned tasks, providing automatic updates as soon as tasks are completed. This module manages document-oriented or process-based tasks, including tasks external to MasterControl. It automates task assignment, routing, escalation, and tracking.
  • MasterControl Equipment Calibration™ manages an organization’s calibration schedule and automatically triggers calibration events before they are due.  The solution routes calibration tasks containing specific instructions to the appropriate personnel for completion and review. A complete record, including calibration data, is stored for inspection by regulatory agencies or other auditors.
  • MasterControl Equipment Maintenance™ manages maintenance schedules and automatically triggers maintenance tasks before they are due.  The solution routes tasks containing specific instructions to the appropriate personnel for completion and review. A complete record, including captured information, is stored for inspection by regulatory agencies or other auditors.

The following new solutions will appeal to medical device companies:

  • MasterControl DHF Spark™ is a preconfigured, easy-to-validate document control system used for collecting, organizing, and approving all the documents necessary to meet FDA design control requirements.  The software is specifically created for automating the design control process at a price affordable for startup and small-sized medical device companies. The software solution can grow with a business, moving into a full MasterControl system that can including training, CAPA, process automation, etc. without losing system efficiency that may have been incorporated along the way. It is ASP-based, extremely easy-to-administer and can usually be installed in a matter of days.
  • MasterControl DHF JumpStart™  is an out-of-the-box system for small- to medium-sized medical device developers.  The solution helps development engineers swiftly organize their work so they spend less time with administrative duties and more time in development.  The software provides multiple simple routes for document collaboration and approval for companies who need a preconfigured best practices design control system at an affordable price.
  •  MasterControl CAPA MD™ automates and effectively manages the CAPA process and integrates it with other quality processes, such as change control, audit, training, nonconformance, and customer complaints, for a holistic approach to quality management.
  • MasterControl Customer Complaint MD™  automates complaint handling, integrates it with the quality system, and manages complaint resolution swiftly and effectively.  Complaint data is instantly available to quality and regulatory specialists as well as development engineers for evaluation, so product review and redesign may commence immediately, if necessary.
  • MasterControl Projects™ connects the project plan to assigned tasks, providing automatic updates as soon as tasks are completed. This module manages document-oriented or process-based tasks, including tasks external to MasterControl. It automates task assignment, routing, escalation, and tracking.
  • MasterControl Equipment Calibration™
  • MasterControl Equipment Maintenance™

Blood and biologics companies will find appeal in this new solution:

  • MasterControl Projects connects the project plan to assigned tasks, providing automatic updates as soon as tasks are completed. This module manages document-oriented or process-based tasks, including tasks external to MasterControl. It automates task assignment, routing, escalation, and tracking.

As with all software developed by MasterControl, these new solutions provide all the features necessary to fully comply with 21 CFR Part 11 requirements. They provide a secure, time-stamped audit trail, reporting, and electronic signature capabilities. Security features include dual passwords for document approval and password expiration, encryption, and certification. MasterControl solutions exceed good business practice requirements for companies that comply with ISO quality standards such as ISO 9000 and ISO 13485.

About MasterControl

MasterControl Inc. is a global provider of GxP process and document management software solutions for life science companies. The MasterControl™ suite is easy to use, easy to deploy, easy to validate, and easy to maintain. It incorporates industry best practices for automating and connecting every stage of the product development cycle, while facilitating regulatory compliance. By combining an integrated platform with a continuum of risk-based software validation products and services, MasterControl drives down the total cost of ownership and enables customers to extend their investment across the enterprise. Hundreds of companies worldwide use MasterControl for easier compliance, faster validation, and better process management. For more information, visit www.mastercontrol.com, or call 800-825-9117.