SALT LAKE CITY – June 27, 2007 – MasterControl Inc., a global provider of GxP process and document management software solutions for life science companies, today announced the release of four new products designed for medical device companies.
MasterControl DHF JumpStart™ is designed to ease the documentation burden experienced daily by medical device companies. MasterControl Customer Complaint MD™ and MasterControl CAPA MD™ automate complaint handling and corrective action / preventive action (CAPA) processes, integrating the two activities with other quality processes. MasterControl Projects™ automates the process of managing projects, particularly those that are document and/or process-based.
The four solutions build on MasterControl's traditional strengths: ease of use, compliance, and connectivity. Each solution is targeted at the small to medium-sized medical device company struggling with the administrative burden of paper-based process and document management.
MasterControl DHF JumpStart™
MasterControl DHF JumpStart is a best practices configuration for design control that can be applied to any MasterControl solution that includes document management. Starting with the DHF JumpStart configuration allows companies to get up and running quickly with an electronic design control system that is based on regulatory requirements and industry best practices. This can drastically reduce implementation and training time resulting in lower overall cost to the company. Features include:
- Electronic DHF: Using MasterControl Organizers, industry best practices, and regulatory guidelines, the DHF is configured to swiftly provide documents as needed, whether for a design review or FDA inspection.
- Preconfiguration Speeds the Work: MasterControl DHF JumpStart is preconfigured to organize documents in a complete design history file ready for design review or FDA scrutiny.
- Faster Turnaround: MasterControl DHF JumpStart automates collaboration, routing, follow-up, escalation, and approval of important design control documentation, removing this as an obstacle of product launch. Using electronic signatures further accelerates the approval process and ensures regulatory compliance.
- Quick Start for Staff: MasterControl DHF JumpStart is out-of-the-box software requiring minimal systems administrator or user training that can be installed in a matter of days. LDAP integration is available, if desired.
MasterControl Customer Complaint MD™
MasterControl Customer Complaint MD is a complete solution that 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. This is a tremendous advantage in today’s litigious society, when slow response to customer complaints can land a manufacturer in the courtroom. Features include:
- Automated Tasks: MasterControl Customer Complaint MD automates all tasks pertaining to handling of customer complaints, including notification, follow-up, and escalation of overdue assignments. Automation helps simplify the compliance environment, making it easier to stay compliant.
- CAPA Integration: MasterControl Customer Complaint MD gives you the option to integrate customer-complaint handling with MasterControl CAPA MD to automatically escalate any serious quality problem.
- Proactive Monitoring: When integrated with MasterControl Rules™, a manager can set thresholds for customer complaints. For example, MasterControl Customer Complaint MD can send an automatic notification to the manager when a certain product receives 10 customer complaints so the manager can take appropriate action as soon as possible.
MasterControl CAPA MD™
MasterControl CAPA MD is an easy-to-use software solution designed to automate and effectively manage the CAPA process and integrate it with other quality processes, such as change control, audit, training, nonconformance, and customer complaints, for a holistic approach to quality management. Furthermore, because it is part of the MasterControl integrated suite, important documentation necessary to properly conduct a CAPA investigation is available within a single system, eliminating the need to consult multiple sources. Features include:
- Automated Routing, Escalation, and Approval: Automates all CAPA tasks, including routing, notification, follow-up, escalation, and approval. Automation helps sustain compliance by simplifying processes.
- Easy Access: Through the Internet, customers, vendors, and others outside the company can participate in the CAPA process. Access to the system is controlled by user rights, ensuring that outside parties only see pertinent information.
- Integrates with Training: Seamlessly integrates with the training process so a CAPA that causes an important change (in product design, SOP, etc.) will automatically invoke training tasks upon approval of the change.
MasterControl Projects automates task assignment, routing, escalation, and tracking. It streamlines the workflow and provides project transparency that fosters accountability. It also allows importing from Microsoft Project to leverage existing knowledge and expertise. Features include:
- Connected: With MasterControl Projects, the project plan is connected to the tasks. For example, MasterControl knows when a document is approved or a process is completed. When this occurs, MasterControl automatically updates the project plan with no manual intervention required.
- Standardized Process: MasterControl will standardize project management by providing an effective framework for the process, from project definition to completion. All tasks, schedules, and resources related to a project will be coordinated under a single system, fostering efficiency.
- Automatic Tracking: MasterControl automates tracking of tasks and monitoring of progress for a more efficient process. Users can create dependencies for a more effective workflow.
- Fast Turnaround: MasterControl automates scheduling, task assignment, routing, tracking, escalation, and approval, greatly speeding up the process and reducing the project management burden. The system provides project transparency to help avoid bottlenecks.
Web-Based Portal Functionality
As with all MasterControl applications, MasterControl DHF JumpStart, MasterControl Customer Complaint MD, MasterControl CAPA MD, and MasterControl Projects utilize the MasterControl web-based portal which includes the following attributes:
- Analytics and Reporting Tool: MasterControl’s advanced reporting capabilities simplify management oversight, making it easy for a product development team to quickly identify product issues, allowing them to incorporate changes into new designs and avoid past mistakes. The tool also demonstrates appropriate controls to regulatory agencies. The solution includes a number of out-of-the-box reports and can be fully customized.
- Validation Offerings: For FDA-regulated companies, MasterControl provides a full product line of validation offerings that are designed to dramatically cut the time, pain, and cost involved in computer software validation.
- Compliant System: 21 CFR Part 11 requires an audit trail as a key control in making electronic records reliable. MasterControl products maintain a secure, time-stamped audit trail that documents the identity of anyone who creates, modifies, or deletes an electronic record. The software records when the action occurred and the reason changes were made. MasterControl meets FDA requirements for electronic signature and software validation. It facilitates compliance with regulatory standards such as ISO 9000 and ISO 13485.
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.