|Clinical Quality Challenges||MasterControl Solution|
Companies with tight deadlines rarely have time to work with software requiring full customization; staffing resources just aren’t available.
|Pre-configuration Speeds Your Work:|
MasterControl Clinical Quality (GCP) JumpStart is preconfigured to organize all documents required for quality compliance for good clinical practice, from SOPs and work instructions to management and organization of research documentation.
|Losing Track of Documentation:|
Communication breakdowns (internally and externally with partners) often cause critical delays in research and missing paperwork creates significant delays in sequential processes.
|Connected Documents and Tasks:|
Since MasterControl is an integrated solution that connects users, documents and processes in a single centralized system, it vastly improves communication and efficiency and ensures that goals and objectives are met and completed in a timely manner.
Documentation compliance requires key documents to be reviewed and approved by several individuals. Time spent waiting on this process can impede quality and integrity of studies.
|Faster Turnaround and Automated Tracking:|
The MasterControl Clinical Quality (GCP) JumpStart automates version control, collaboration, document routing, task notifications, escalation, and approval of important documentation. Using electronic signatures further accelerates the approval process and ensures regulatory compliance. In addition, it also automates the management of annual reviews.
|Slow Installation and Training:|
Other document software programs can take months to install, weeks for a systems administrator to set up and many days for a user to learn.
|Quick Start for Staff:|
MasterControl’s Clinical Quality (GCP) JumpStart is out-of-the-box software requiring minimal systems administrator or user training and can be installed in a matter of days. LDAP integration is available, if desired.
Features and Benefits of MasterControl GCP Software
Affordable: The total cost of ownership is minimal because no special equipment is required.
Web-based Platform: MasterControl is Web-based so it can connect all employees involved in the design process from virtually anywhere.
Best Practice Processes: The system is pre-configured based on industry best practices and clinical quality compliance guidelines. Users are able to create, collaborate on, and route design documents without having to spend hours configuring the system.
Analytics and Reporting: MasterControl’s advanced analytics and reporting capability provides standard and customized reports. Design control documents can be summarized in multiple levels such as product, department, and document type. MasterControl includes dashboard and drill-down features.
Automated Routing, Escalation, and Approval: Automates all design control document tasks, including routing, notification, follow-up, escalation and approval to improve efficiency and time-to-market. Automation helps sustain compliance by simplifying processes.
Collaboration: MasterControl allows project team members from different departments and key clinical vendors from outside the organization to collaborate on crucial documents, potentially reducing costly errors that must be corrected late in the development cycle.
Revision Control: Automatic revision control ensures that the history of the design is properly documented. Rights-based access to documents ensures that the most current, approved version of a document is being used.
Electronic Approval Signatures: The system allows documents to display for review, collaboration, and/or electronic approval, accelerating the approval process.
Grows with Your Business: Familiarity with the pre-configured system will allow the customer’s sysadmin to make changes to accommodate new processes and procedures. As the company grows, it can move into a full MasterControl system that can include training, process automation, etc., without losing the efficiency of the preconfigured system or changes that may have been incorporated along the way.
Part 11-Compliant Features: Provides time-stamped audit trail, reporting and electronic signature capabilities that fully satisfy FDA’s 21 CFR Part 11 requirements. Security features include dual passwords for document approval; password expiration, encryption and certification; and account lockout to stop unauthorized users from gaining system access.
For More Information on MasterControl's Clinical Quality Software Systems
For more information about our clinical quality software systems and jumpstart options, please feel free to contact a MasterControl representative.