Companies conducting clinical research studies are focused on establishing not only the safety and efficacy of their investigational products but also on the integrity and quality of the data they collect in compliance with research regulations. Clinical quality groups have a need for tools that will support them with the organizational processes and conditions under which clinical studies can be planned, performed, monitored, recorded, archived and reported.
The MasterControl Clinical Quality (GCP) JumpStart™ is a Web-based system that provides a complete document management solution for all of an organization’s clinical quality document needs.
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The MasterControl Clinical Quality (GCP) JumpStart provides out-of-the-box best practice configuration of document types and routes for collaboration, approval and review, electronic signatures, roles, version control, lifecycles, and PDF rendering specifically for GCP. It is an affordable solution for companies who want document control processes for the management of documents such as SOPs, work instructions and specifications documentation required by 21 CFR Part 312, Part 50 and Part 812.
The MasterControl Clinical Quality JumpStart configuration is based on the ICH GCP E6 (RI) Guideline. This guideline was developed by the appropriate ICH Expert working group and has been subject to consultation by the regulatory parties, in accordance with the ICH process. The objective of this ICH GCP guideline is to provide a unified standard for the European Union (EU), Japan and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.
This configuration is designed for pharmaceutical, biologics and/or clinical research organization (CROs) looking to manage clinical quality documentation outlining procedures, methods, roles and responsibilities for all activities executed during clinical research studies, as well as procedures for pre- and post-study activities.
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 about our clinical quality software systems and jumpstart options, please feel free to contact a MasterControl representative.