News - GCP Document Management...
SALT LAKE CITY – July 2, 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 pharmaceutical and biotech companies.
MasterControl GCPDocs JumpStart™ is designed to ease the documentation burden experienced daily by pharmaceutical companies. MasterControl Projects™ automates the process of controlling projects, particularly those that are document and/or process-based. MasterControl Customer Complaint Pharma™ and MasterControl CAPA Pharma™ automate complaint handling and corrective action / preventive action (CAPA) processes, integrating the two activities with other quality processes.
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 pharmaceutical company struggling with the administrative burden of paper-based process and document management.
MasterControl GCPDocs JumpStart™
MasterControl GCPDocs JumpStart is a software system for collecting, organizing, and reviewing all the documents required to meet FDA Good Clinical Practice (GCP) requirements. Starting with the GCPDocs JumpStart configuration allows pharmaceutical and biotech companies to get up and running quickly with an electronic document management 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. Benefits include:
- Preconfiguration Speeds the Work: MasterControl GCPDocs JumpStart is preconfigured to organize and manage documentation to be used throughout the product development lifecycle from discovery to commercialization.
- Faster Turnaround: MasterControl GCPDocs JumpStart automates collaboration, routing, follow-up, escalation, and approval of important clinical study documentation, removing this as an obstacle to clinical progress of the candidate drug. Using electronic signatures further accelerates the approval process and ensures regulatory compliance.
- Quick Start for Staff: MasterControl GCPDocs 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 Projects automates task assignment, routing, escalation, and tracking. It streamlines the workflow and provides project transparency that fosters accountability. Benefits include:
- Connectivity: With MasterControl Projects, the 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. The system provides project transparency to help avoid bottlenecks.
MasterControl Customer Complaint Pharma™
MasterControl Customer Complaint Pharma 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 pharmaceutical company in the courtroom. Features include:
- Automates Tasks: MasterControl Customer Complaint Pharma 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 Pharma gives you the option to integrate customer-complaint handling with MasterControl CAPA Pharma 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 Pharma can send 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 Pharma™
MasterControl CAPA Pharma 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. Benefits include:
- Automates 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.
Web-Based Portal Functionality
As with all MasterControl applications, MasterControl GCPDocs JumpStart, MasterControl Projects , MasterControl Customer Complaint Pharma and MasterControl CAPA Pharma, utilize the MasterControl web-based portal which includes the following benefits:
- Analytics and Reporting Tool: MasterControl’s advanced reporting capabilities increase 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 Flexibility: For FDA-regulated companies, MasterControl provides several flexible validation offerings and services to meet each company’s individual validation requirements. These offerings dramatically cut the time, pain and cost involved in validation to ensure continuous compliance.
- 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, when the action occurred, and the changes made to the record. MasterControl meets FDA requirements for electronic signature and software validation. It facilitates compliance with regulatory standards such as ISO 9000 and ISO 13485.