MasterControl GCPDocs JumpStart Document Management System

Document Management System for Managing Documents for Clinical Trials to Ensure Compliance with FDA GCP Requirements

For many years, the conducting of clinical trials relied on the integrity of the personnel involved in operating the trial. The introduction of good clinical practice (GCP) principles established an era of regulation previously unknown in the pharmaceutical and biotechnology industries.

The detailed documentation needed to meet GCP requirements could conceivably require organization and storage of thousands of pages. Additionally, a company filing a New Drug Application (NDA) must follow a set of guidelines which require a specific format. Failing to comply with the formatting directions means costly delays in time to market and profitability.

How Can MasterControl Help You?
MasterControl GCPDocs JumpStart provides a solution for collecting, organizing, and reviewing all the documents required to meet the GCP requirements. It is specifically preconfigured according to regulatory standards and industry best practices to help organize and control nonclinical, clinical, and regulatory documents to meet NDA document requirement needs for growing pharmaceutical and biotechnology companies. The software provides multiple simple routes for document collaboration, approval, and review. It's an affordable solution for companies who want to automate their document control process.

Here's how MasterControl GCPDocs JumpStart addresses some of the major challenges that companies face in meeting GCP requirements:

Document Management System Challenges		MasterControl Document Management System Solutions
Disconnected Processes Communication breakdown is likely to occur in a document control system that consists of disconnected processes. Missing a step in the GCP process may cause critical delays in product development.		Connected Processes MasterControl GCPDocs JumpStart is an integrated solution that connects 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.
Poor Turnaround For those with paper-based systems, paperwork often ends up in a pile on somebody's desk, creating a significant turnaround challenge in a sequential process.		Faster Turnaround MasterControl GCPDocs JumpStart automates version control, document routing, follow-up, and escalation of document review and approval processes.
Go Configure it Yourself Smaller companies with tight deadlines rarely have time to work with software requiring full customization; staffing resources just aren't available.		Preconfiguration Speeds Your Work MasterControl GCPDocs JumpStart is preconfigured to organize nonclinical, clinical, and regulatory documents for pharmaceutical or biotechnological companies.
Hours of Prep Other document management programs can take exorbitant amounts of time for a systems administrator to set up and for a user to learn.		Quick Start for Staff GCPDocs JumpStart is an out-of-the-box software requiring minimal system administrator or user training. LDAP integration is available, if desired.
Poor Tracking IIt's time-consuming to physically track paperwork. A manual system makes it almost impossible to identify and avoid bottlenecks.		Automatic Tracking The MasterControl GCPDocs JumpStart system tracks the document through the collaboration, review and approval steps, allowing the document owner to efficiently move the document through these processes and complete their work quickly.

Summary of Features: MasterControl GCPDocs JumpStart is 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.

.Below is a summary of its key features:

• Best Practices Documents and Processes: The system is pre-configured with document types, lifecycles, workflows, and permissions set 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. GCPDocs Jumpstart can be installed on-site or as an ASP implementation. The ASP model makes GCPDocs JumpStart more affordable for small companies who have limited IT infrastructure but require a scalable document control system.
• Electronic Approval Signatures: Facilitates the online document control process, reducing the administrative workload.
• 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.
• 21 CFR Part 11 Features: As with all software developed by MasterControl, the GCPDocs JumpStart provides all the features necessary to comply with 21 CFR Part 11 requirements. It provides a secure, time-stamped audit trail, reporting, and electronic signature capabilities. Security features include dual passwords for document approval, and password expiration, encryption, and certification.
• Continuous Validation: For FDA-regulated companies, MasterControl offers a "continuous validation" approach that dramatically cuts the time, pain, and cost involved in validation.
• Organizers: MasterControl's Organizer, similar to Windows Explorer, is an easy to use tool that helps users find and access documents quickly. Using Organizers, documents can be gathered into logical groupings and made available to workgroups based on a project, study, clinical site or other document attributes. Documents required for a specific regulatory filing can also be collected and reviewed as a group in preparation for a submission.
• Publishing: MasterControl offers automated conversion/publishing to PDF throughout the document lifecycle. Auto converting of documents to PDF reduces errors commonly associated with manual publishing. PDF conversion from multiple document types into a common, unalterable format helps improve efficiency and reduce costs by eliminating additional desktop software that would be required for users to view documents.
• 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.
• Web-based Platform: MasterControl is Web-based so it can connect all employees involved in the design process from virtually anywhere.
• Collaboration: MasterControl allows project team members from different departments and key suppliers from outside the organization to collaborate on crucial design documents, potentially reducing costly errors that must be corrected late in the development cycle.

About MasterControl Inc.MasterControl Inc. is a global provider of GxP 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.