Document Control Software Systems
Document control is an essential requirement in regulatory environments, touching all quality processes. It is a major stumbling block for many companies. MasterControl's document control software addresses the world's most stringent regulations and standards to ensure compliance. It reduces overall compliance cost and increases efficiency to accelerate time to market.
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Life Science Companies Trust MasterControl
Over 1,000 organizations worldwide, including top federal and state regulatory bodies, entrust MasterControl with their document management. MasterControl’s document management system, MasterControl Documents™, was designed by industry professionals who understand the compliance challenges associated with document control.
Document Control Challenge |
MasterControl Solution |
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Inefficiency Manually routing documents, obtaining approval and signatures, implementing changes and locating documentation are error-prone, time-consuming processes. |
Increased Efficiency MasterControl automates routing, delivery, escalation and approval of documents, and provides a centralized, secure repository to simplify document retrieval. |
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Lack of Revision Control Keeping track of document versions and ensuring that only the most recent version is being used is difficult in a manual process. |
Automated Revision Control With MasterControl, revisions are automatically tracked and only the most recent version of a document is made available. |
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Disparate Systems Having a different system for each quality process means that tasks fall through the cracks and miscommunication is likely. |
Connected System MasterControl users and systems are all connected, making it easy to get an overall view of the quality system and track what tasks need to be completed. |
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Unprepared for Audits Good document control is essential to passing an audit, but manual systems make it difficult to track and produce the necessary documents. |
Increased Audit Preparedness MasterControl Documents keeps companies in an audit-ready state by having a single location for all documents which can easily be searched. |
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Poor Collaboration Process Collaborating while using a manual process means either dozens of emails, phone calls or in-person meetings. |
Effective Collaboration MasterControl allows collaboration within the system in a secure, real-time environment. Users can add input and see the input of others at any time. |
Paperless Document Control
A document control system that uses physical, paper documents doesn’t allow for much control. Locating the most recent version of a document, determining what changes have been made and getting approval are all considerably more difficult without automation. Paperless software solutions have gained popularity due to the provided efficiency and visibility lacking in a paper-based system.
Features of the MasterControl Document Control Software
- Automated Document Control Streamlines the approval, distribution, retrieval and obsolescence of documents.
- Reporting Capabilities Has standardized and customized reports that include dashboard, drill-down and scheduling features.
- Revision Control Limits access to the most recent version of a document and automatically tracks revision history.
- Centralized Repository Stores all documentation in a single location, simplifying audits and inspections.
- Metadata Links Automatically transfers document information to eliminate out-of-sync metadata during revision processes.
- 21 CFR Part 11 Compliance Provides time-stamped audit trail, reporting and electronic signature functionality in accordance with federal regulations.
- Change Control Tracks changes between revisions and automated change control tasks, such as scheduling reviews, designating reviewers and sending out reminders.
- Virtual Collaboration Enables collaboration across locations and time zones, including with those who are not MasterControl users.
- Controlled Copies Creates controlled copies with customizable watermarks, sequential numbering and location tracking.
- Autoload Feature Allows users to drag and drop new documents into preconfigured folders, greatly simplifying document creation and arrangement.
The QMS Provider for the FDA
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.
Need more information?
To learn more about MasterControl's software systems, please contact a MasterControl representative.
