Document Control Software System

Automating a Document Control Software System for the FDA and ISO Environments

In regulated environments, document control and document management are vital to attaining quality and compliance. To control quality, one must effectively control quality documentation, such as SOPs, policies, quality manuals, CAD files, and engineering change orders.

MasterControl Documents™, a core application in the MasterControl™ integrated business process management suite, automates and effectively manages document control process to help ensure compliance with FDA 21 CFR Part 11 regulations, ISO quality standards, and other regulatory requirements.

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	Product Data Sheet: MasterControl Documents™
	Product Data Sheet: MasterControl Publishing™
	Product Data Sheet: Validation Services
	White Paper: Reducing the Documentation Burden in FDA Design Control
	Webinar: Simplifying Batch Record Documentation in Preparation for MES/EBR

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How MasterControl Makes Your Job Easier (3:50)

Creating a Paperless Process Using MasterControl (3:38)

Using MasterControl for FDA Compliance (3:53)

A document control software system must be validated and kept in a constant state of validation. This is critical to FDA 21 CFR Part 11 compliance. MasterControl also offers a line of validation products and services addressing different levels of validation needs based on individual risk assessment. They are designed to allow "continuous validation" for companies doing business in regulatory environments by making validation of software upgrades easier, faster, and more cost-effective.

How our Document Control Software System can Benefit You

Here's how MasterControl Documents™ addresses some of the major challenges that companies face in managing and controlling documents.


Document Control Challenges		MasterControl Documents™ Software Solution

Inefficient Document Control System Manual systems are inefficient, requiring tremendous man-hours in terms of routing documents, obtaining approval and signatures, face-to-face meetings to discuss changes, and search and retrieval of documents during inspections and audits.		Efficient Document Control System MasterControl's Document Control Software System automates routing, delivery, escalation, and approval of documents. It can handle all types of documents regardless of the software used to create them. MasterControl features a centralized, secure repository that makes search and retrieval easy during inspections and audits.

Lack of Document Revision Control In a paper-based system or hybrid system, employees check out documents and other materials (engineering drawings, etc.) manually. Tracking down any document activity is difficult. Making a change in an SOP or other document requires manual submission of a change request or discussion of the change in face-to-face meetings.		Automated Document Revision Control The Document Control Software System that we offer provides automatic revision control to ensure that only the current version of a document is available. Changes can be initiated and approved electronically. When a user makes a change in the InfoCard (the MasterControl tool that provides basic information for every record), the user must enter a reason for the change. The system tracks these changes and makes them available through reports. MasterControl Documents always ensure users are able to access the right document any time.

Disconnected Document Control Processes Communication breakdown is likely to happen in companies that rely on disparate tools and processes to manage the quality system. Ineffective communication can lead to significant delays and adverse outcomes.		Connected Document Control Processes The Document Control Software System that we offer connects all quality subsystems like CAPA, change management, audit, and training. For example, any CAPA that results in a document change will automatically invoke training once the change is approved. MasterControl is Web-based so documents are accessible to all authorized users from virtually anywhere.

Lack of Visibility It's difficult to generate accurate and timely reports and trends using disparate electronic spreadsheets and flowcharting tools. Without a coherent reporting system, managers are unable to get the big picture of the quality management system.		Increased Management Visibility The Document Control Software System that we offer provides advanced analytics and reporting capability, including customizable reports and online charting. Through the reports, managers get a real-time view of the quality processes and can be more proactive about improving the quality system.