SALT LAKE CITY – June 12, 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 GCPDocs Spark™, an ideal solution for early stage pharmaceutical and biotechnology companies that need an out-of-the-box, preconfigured document control system based on best practices.
“GCP covers such a wide range of activities,” said Lane Hirning, pharmaceutical product manager for MasterControl. “A pharmaceutical company initiating a new product deals not only with product design but with protocols, reports, contracts, and a myriad of other documents. All of this information has to be captured and organized for review, approval, and possibly submission to the FDA. GCPDocs Spark is an out-of-the-box document management system that electronically captures and helps organize all this information so that it’s easy to retrieve and use. Small contract research organizations (CROs) can also feel overwhelmed by all the documentation and use GCPDocs Spark for better document control and management.”
The release of GCPDocs Spark is consistent with MasterControl’s commitment to provide a solution to help growing pharmaceutical and biotechnology companies achieve greater efficiency, faster time-to-market, and higher product quality.With GCPDocs Spark, MasterControl aims to:
- Connect users, documents and processes in a centralized system. This connectivity vastly improves communication and efficiency, ensuring that goals and objectives are met and completed in a timely fashion.
- Automate data collection, routing, follow-up, and escalation of document review and approval processes.
- Reduce IT resources requirements by hosting the application on MasterControl servers. MasterControl experts provide rapid deployment, professional validation services, and complete maintenance of the system.
- Track documents through the collaboration, review and approval steps, allowing the document owner to efficiently move the document through these processes and complete their work quickly.
Below is a summary of its key features:
- Preconfigured: The system is preconfigured with document types, lifecycles, workflows, and permissions sets that are common to small companies in pharmaceuticals and biotechnology. Features like collaboration, out-of-office routing, and e-mail import all provide time-savings and process efficiency that enables small companies to get away from the paper shuffle and back to the business of developing new medicines and therapies.
- Affordable: The total cost of ownership is minimal because no special equipment is required. The ASP model makes GCPDocs Spark affordable for small companies who are not ready for a full-scale document control system.
- ASP Model: MasterControl serves as the Application Service Provider (ASP) for GCPDocs Spark. The system is extremely easy to administer and can usually be installed in less than a week and often just in a matter of days.
- Electronic Approval Signatures: The system allows documents to display for review, collaboration, and/or electronic approval, facilitating the approval process.
- Turnkey Solution: MasterControl GCPDocs Spark is ready out-of-the-box, drastically reducing time required for implementation. There is no special hardware to buy or system to configure. Data backup, antivirus protection and redundant hardware are all provided with minimal upfront costs.
- Grows with Your Business: If required, MasterControl’s Professional Services staff can make changes to the preconfigured software to meet new requirements as a company proceeds through its growth cycle. More importantly, as the company grows, you can move into a full MasterControl system that can include training, CAPA, process automation, and other activities without losing the efficiency of the preconfigured system or changes that may have been incorporated along the way.
- Compliant System: As with all software developed by MasterControl, the GCPDocs Spark document control solution provides all the features necessary to fully comply with the software-related requirements of 21 CFR Part 11.
- 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.
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.