MasterControl TotalPharma™ -
An End-to-End Software System for Pharmaceutical and Biotech Companies

MasterControl Offers a Complete Software System Designed to Automate Business Processes for Pharmaceutical and Biotech Companies

Managing documents, training, and business processes are nightmares shared by all pharmaceutical and biotech companies. MasterControl TotalPharma™ exchanges the nightmares for a dream of a solution that enables these companies to get their products to market faster and improve compliance at the same time. MasterControl TotalPharma has been specifically designed to help pharmaceutical and biotech companies manage all documents and automate regulatory-related processes and training in a single platform.

Who Can Benefit from MasterControl TotalPharma?

R&D Managers (Regulatory, Clinical, and Pre-Clinical): Can use MasterControl TotalPharma to more efficiently organize, search, and take inventory of various study documents within the centralized, secure MasterControl system. With MasterControl's automated routing and approval functionality, managers can more easily oversee project teams composed of resources from multiple departments, even when those teams are working on multiple projects at the same time. MasterControl also ensures that correspondence from regulatory agencies, CROs, and suppliers is linked to the appropriate documentation.

R&D Document Authors: Can author documents easily from compliant templates and not have to worry about reworking them to match the templates. Users of Word 2007 can create, revise, and redline documents without leaving Word using the new MasterControl toolbar. With MasterControl, PDFs with content bookmarks can be automatically created for regulatory submissions as well as document control functions. Since MasterControl is a connected and complete system, authors won't have to constantly move back and forth between disparate systems (from e-mail to Word and then to the document management system, etc.) in order locate a document, revise it, and then send it on for review or approval - MasterControl allows all such actions to be taken within the same integrated system.

Manufacturing/Operations:Can easily track all specifications, deviations, and nonconformances throughout the development cycle. MasterControl TotalPharma ensures that all appropriate personnel are trained on the most up-to-date SOPs and work instructions. The system also automates training tasks and allows training records to be located without difficulty in a centralized system.

Clinical Personnel: Can avoid paper filing backlogs that create a "black hole" of documents that are nearly impossible to find. Because the MasterControl system is electronic and automated, searching archives for trial documentation (protocols, IRB information, etc.) is simple. Electronic copies of documents, e-mails, CVs, etc., from study sites are readily accessible in a single, centralized system.

Management: MasterControl TotalPharma can provide a comprehensive solution for any life science organization regardless of existing in-house capabilities. Whether the organization simply needs training on the system's functionality or requires assistance configuring the system to specific needs, TotalPharma can be packaged with any level of service and support the organization requires. An organization requiring expert knowledge can have MasterControl's skilled advisory team analyze the circumstances and develop and clearly map out those requirements.

Features and Benefits of MasterControl TotalPharma

Accelerates Time to Market
Launch products to market faster by enabling the entire organization to execute and communicate tasks more efficiently using tools that are familiar and with which employees are already proficient. Some of the benefits that MasterControl TotalPharma and its associated services offer that can help get products to market faster include:

Faster document creation using pre-approved company templates for each document type
Efficient collaboration on critical documents between cross-functional teams that accelerates the document author/review cycle
Capability to auto-create PDFs with bookmarks, watermarks, and e-signature manifests
Out-of-the-box, best practices configuration to help manage clinical trial documents
A Web-based platform that eliminates geographic dispersion constraints
Collaboration workspaces that have the capability to involve multiple departments, outside suppliers, consultants, etc.
Automated task assignment, routing, escalation, and tracking which speeds up document- and process-based projects
Project management tools that dramatically reduce administrative overhead by automating task tracking and distribution
Process library templates that essentially create "out-of-the-box" process automation that requires little configuration, resulting in faster implementation time
Validation scripts and materials that decrease validation time and effort, which gets production started faster
Optional connectors to submissions publishing tools, scanning tools, and other common enterprise applications like SharePoint keep MasterControl 'connected' to the business and not just another silo

Makes Efficiency and Compliance Synonymous
MasterControl provides companies with all the necessary tools and services to make product development and quality as efficient as possible.

MasterControl can help avert submission delays caused by lost documents or submission of incorrect versions of documents that may require re-submission
MasterControl helps avoid the submission of non-compliant documents that lack bookmarks or navigation features using compliant templates
The system ensures that access to all supplier-related quality information is available from a single interface, which allows for rapid assessment and monitoring
Regulatory personnel are able to participate in the development cycle and can easily repurpose documentation for use in regulatory submissions
Part 11 compliance ensures that your information repository can replace paper, not simply supplement it
E-mail import functionality allows critical correspondence with regulatory authorities, CROs, or suppliers to be automatically added to the system, linked to the related documentation, and tracked as any other document

Integrated Enterprise System

MasterControl is a connected and inclusive system, serving as a single source for product definition, providing a central repository for all documentation
MasterControl ensures that authors, CROs, suppliers, etc., can all stay connected in one secure system where all critical information is located
E-mail import functionality allows critical correspondence with regulatory authorities, CROs, or suppliers to be automatically added to the system, linked to the related documentation, and tracked as any other document
MasterControl seamlessly integrates with the tools users work with every day like Microsoft Outlook and Word, meaning that everyone can participate in the process using their preferred applications
MasterControl TotalPharma provides document authors with a Word 2007 toolbar that allows them to create new documents and collaborate on existing documents without ever leaving Microsoft Word
Author and time-stamped redlines allow project teams to collaborate on documents and follow changes to the document
Document collection can be easily maintained and monitored using auto-load network folders. Users can simply drop a document into the system and have it automatically routed for approval
Documents can be shared with outside reviewers using external links
Using MasterControl's Organizers, project teams are given a folder view that matches their project document binders
Users can easily create document inventories in the Organizer and quickly view a contents report to see which documents are approved and which are in draft
Clinical staff can quickly find all documents associated with a specific study or site using dictionary driven metadata and virtual folders
Quality managers can track process automation via automatic reporting based on time or thresholds
Training managers can effortlessly create courses, assign curriculum, and track training tasks. Training reports can be automatically delivered directly to managers' e-mail inbox on a weekly basis indicating overdue training and pending training for each employee
The system features tightly integrated applications that can be enhanced even further by MasterControl's associated services offerings

Unparalleled Services

MasterControl's experts can get the TotalPharma solution up-and-running quickly in order to maximize time and resource savings. MasterControl services professionals provide much more than just installation support; MasterControl experts can help build processes, structure file systems, design forms, configure reports, validate, or provide any other support services necessary to reach customer objectives.

Additional Services Beyond the MasterControl TotalPharma Solution

MasterControl experts can do anything a client needs to reach required objectives. MasterControl can even serve as an organization's training department - whether it is individual training for new employees or educating an entire department on new processes that have been implemented, MasterControl has a solution. Trainees can learn via recordings or in a classroom environment with a live instructor.

MasterControl is renowned for having industry experts readily available for clients. Preparing for an audit? Struggling with validation? Looking for better vendors? Whatever it is, MasterControl's experts have seen it before. Whether it is a long-term consulting relationship or a short-term project that requires management, MasterControl can help.

Product Components of the MasterControl TotalPharma Package

Services Components of the MasterControl TotalPharma Package

MasterControl Project Management Services™
MasterControl Education Services™
MasterControl Installation Services™
MasterControl Implementation Services™
MasterControl Process Implementation Services™
MasterControl Process Library Installation Services™
MasterControl Validation Services™
MasterControl Post Go-Live Assessment™

MasterControl TotalPharma is easy to configure, easy to validate, and easy to use. It is a dream solution that enables companies to get their products to market faster and improve compliance at the same time. MasterControl TotalPharma offers your enterprise everything it needs for total document and process control in a single solution. MasterControl provides enterprise level document management and document control while maintaining direct links between training and documentation as well.