Pharmaceutical Document Management Software System
MasterControl Pharma R&D: A Complete Software System Designed to Automate Document and Training Management for Pharmaceutical Companies
Even a single day's delay in getting a product to market can result in the loss of millions of dollars of potential profits. MasterControl Pharma R&D document management software system is a utopian solution that integrates advanced document control and management with a training component to create an unparalleled system specifically preconfigured for pharmaceutical companies' document and project management needs.
Who Can Benefit from MasterControl Pharma R&D Document Management Software Systems?
Development Personnel: The electronic pharmaceutical MasterControl system is secure, efficient, and Web-based, meaning that documents can be revised and approved in a timely manner, even by users across multiple departments or geographical locations. MasterControl automates the routing and approval of document tasks, dramatically reducing the amount of project meeting time that is needlessly consumed signing off on tasks. By providing a secure and centralized repository for crucial documentation the Pharma R&D document management system makes it easy to track, store, and approve documents from study sites and investigators as well as manage multiple revisions of protocols and similar documents. MasterControl keeps the entire enterprise connected and makes it possible to more efficiently manage project teams that are made up of resources from multiple departments.
Regulatory Departments: With MasterControl, regulatory professionals don't have to waste time searching for current versions of documents or manually inventorying and collecting documents for submissions. Tracking correspondence from regulatory agencies and linking it to appropriate project documentation is quick and easy with MasterControl's comprehensive pharmaceutical document management system. The solution also automatically creates PDFs, appropriately bookmarks documents, and simplifies the preparation of legacy documents for submissions.
Manufacturing/Operations: MasterControl ensures that documents crucial to manufacturing processes are always up to date. Manufacturing and operations personnel are connected by MasterControl R&D pharmaceutical software to ensure that only the most up-to-date product specifications are being used. The Pharma R&D document management solution also decreases time wasted recalling old copies. The training component of the solution makes it easy to electronically schedule and track training of staff on new SOPs, updated work instructions, etc.
Management: MasterControl Pharma R&D document management software can provide a comprehensive solution for any 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, Pharma R&D can be packaged with any level of service and support the organization requires. An organization lacking knowledge of particular requirements that must be addressed can have MasterControl's expert advisory team analyze the circumstances and develop and clearly map out those requirements.
Features and Benefits of MasterControl Pharma R&D Document Management Software Systems
Accelerate Time to Market
The Pharma R&D document management system makes it possible to significantly decrease the amount of time spent gathering and managing critical documents during development. Some of the benefits that MasterControl Pharma R&D offers that can help push products to market more rapidly include:
Approved document templates and preconfigured routes that ensure documents are created, reviewed, and approved correctly the first time.
Assurance of consistent documents.
Capability of cross-functional teams to collaborate on critical documents, thereby accelerating the document author/review cycle.
Automatic creation of PDF renditions with appropriate bookmarks and e-signature manifests.
Automated training on new revisions of documents.
E-mail notifications and scheduled training reports that allow management to track training effectiveness.
Out-of-the-box, best practices configuration for clinical trial documentation which minimizes configuration time and makes it possible to move to production faster.
A Web-based system that involves manufacturing, marketing, quality, and regulatory personnel early in the development cycle to maximize the likelihood of product success.
MasterControl Pharma R&D document management software enables project teams to perform and communicate tasks more efficiently using the tools with which they are already proficient. Companies can make efficiency and compliance synonymous throughout the enterprise with tools that make product development and quality flow more efficiently.
Document authors can work in MS Word 2007 and quickly upload legacy documents, revise existing documents, or launch new documents onto collaboration workflows directly from Word.
Project leaders can automate the creation of project documentation as project tasks, thereby avoiding time consuming meetings.
Management teams can quickly assess project status with reports automatically sent to their e-mail inboxes with any desired frequency.
Supervisors can quickly access training folders of their reports as well as obtain reports of missing or delayed training activities.
Training can utilize formal classroom courses and graded exams to document understanding of complicated procedures or it can be set up to be a simple "read and understood" signoff.
Departments Linked by a Connected System
MasterControl Pharma R&D document management software offers not only seamless integration, but the capability to expand as enterprises grow, develop, and thrive.
The MasterControl system features tightly integrated applications.
Departments can collaborate on various documents with internal and external parties in a private workspace.
Seamless integration with the tools used by all employees every day: Outlook, Word, MS Project, etc.
E-mail within the system can be automatically captured and linked to relevant documents.
Project tasks and documents can be automatically created, minimizing project meetings.
Drag-and-drop autoload folders facilitate the gathering of documents from external parties.
As companies mature, additional beneficial MasterControl solutions can be added to fit expanding needs.
The MasterControl Advantage
In addition to avoiding product changes late in the development process, delays in getting a product to market, and submissions that need to be rewritten, MasterControl offers other significant benefits, such as:
Advanced document control functionality
Pharmaceutical domain expertise
Complete validation offerings
Integrated training with exams
Preconfiguration for clinical trials documentation
E-mail import functionality
Native and PDF collaboration capability
MasterControl's experts can get the Pharma R&D document management software 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 Pharma R&D Software 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 Pharma R&D Document Management Software Solution
MasterControl PDF Documents™
MasterControl GCP JumpStart™
MasterControl GCP JumpStart PQ™
Services Components of the MasterControl Pharma R&D Package
MasterControl Inc. and its partner, i4DM, are expanding their FDA project, serving as the QMS providers for a second FDA division. The two companies have been the QMS providers for the FDA's Office of Regulatory Affairs since 2009. Now they will also serve as quality providers for the Division of Pharmaceutical Analysis, which is part of the FDA's Center for Drug Evaluation and Research.