Document Control Software Systems

MasterControl provides Document Control Systems allowing companies to thrive in regulatory environments.

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.

Product Data Sheet

MasterControl Documents™

Product Videos

Hundreds of companies around the world use MasterControl to automate core business processes and document management activities to promote collaboration, improve decision making, and accelerate time to market.

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Demo: MasterControl Document Control Software

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Demo: MasterControl Change Control Software

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MasterControl Spark - Small Businesses Document Control

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How a Pharma Company Uses MasterControl Document ControlÖ and CollaborationÖ

How a Pharma Company Uses MasterControl Document Control™ and Collaboration™

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Product Data Sheet: MasterControl Documents™ Product Data Sheet: MasterControl Collaboration™ Product Data Sheet: MasterControl Change Control™
White Paper: Automating Document Control Processes White Paper: Reducing the Documentation Burden in FDA Design Control White Paper: How Effective Document Management Helps Pharmaceutical Companies Accelerate Time to Market
Infographic: 9 Pitfalls to Avoid During the Document Control Process
e-book: Compliance and Technology: How to meet changing FDA expectations
Toolkit: 9 Free Resources to Boost Your Document Control System

Document Control Challenge	MasterControl Solution
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.
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.
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.
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.
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.

Document Control Challenge

MasterControl Solution

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.

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.

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.

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.

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.

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.

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