Document Control Software
Features & Benefits

Automating Document Control Software Processes in FDA and ISO Environments

In both FDA and ISO environments, document control is key to attaining quality and compliance. To control quality, one must control quality documentation, such as SOPs, policies, and quality manuals. Controlling quality documentation requires an effective document control system.

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

Recognizing that validating a document control software solution and keeping it in a constant state of validation is critical to FDA 21 CFR Part 11 compliance, MasterControl offers comprehensive, full-cycle validation, including IQ, OQ, and PQ validation tests. MasterControl continuously develops new methods to cut the time involved in validating a system and to make it easier to validate software upgrades, both of which are essential in lowering overall validation cost.

Watch Customer Video Creating a Paperless Process Using MasterControl (3:38)

How can MasterControl Documents™ Benefit You?

Here's how MasterControl Documents software addresses some of the major challenges that companies face in establishing and maintaining a document control system.

Document Control Control Challenges		MasterControl Documents™ Software Solution
Inefficient Paper-Based Document Control System Companies with multiple facilities and employees in different locations may find it cheaper initially to maintain separate quality systems, especially paper-based or hybrid document control systems. In the long term, however, these systems are inefficient, requiring tremendous man-hours in terms of routing SOPs and other documentation, obtaining approval and signatures, face-to-face meetings to discuss changes, and manual search and retrieval of documents during FDA inspections or ISO audits.		Efficient Document Control System MasterControl Documents automates routing and delivery of SOPs, policies, and other documentation. It's uniquely qualified to be the focal point of a quality management system because it can handle all types of documents regardless of the software used to create them. It provides a secure and centralized document control repository that makes search and retrieval easy during inspections and audits. MasterControl Documents is Web-based so documents are accessible to all authorized users from virtually anywhere.
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 MasterControl 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 delays and poor results.		Integrates Training with Document Control Processes MasterControl Documents is an integrated solution that connects all quality sub-systems like CAPA, change management, audit, customer complaint, and training. For example, a customer complaint that warrants a CAPA will be immediately escalated. Any CAPA that results into a change will automatically invoke training once the change is approved.
Lack of Oversight It's difficult to generate accurate and timely reports and trends using disparate tools (electronic spreadsheets, flowcharting software, paper documents in binders). Without an effective reporting tool, managers are unable to get control of their quality management system.		Increased Management Visibility MasterControl 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 their quality system.

Document Control Software Facts

• MasterControl Documents has been successfully implemented, validated and inspected in FDA environments without any instances of non-compliance since its introduction in 1998
• Dramatically reduces the time it takes to bring a new product to market by speeding up the process for document change, approval, notification, and distribution
• Is an off-the-shelf configurable product designed for rapid installation, implementation, and validation
• Ensures documentation integrity so employees always have the most updated document at their fingertips

Core Capabilities

• Combines powerful electronic routing and approval
• Full audit trail and reporting
• Electronic signature management and control
• Ensures 21 CFR Part 11 compliance with security and integrity of documents
• Computer systems validation plan and implementation including
  • Validation-ready for IQ (Installation Qualification)
  • OQ (Operational Qualification)
  • PQ (Process Qualification)
• Scalable, open systems architecture
• Supports industry-standard databases
  

Main Document Control Features

• Revision Control: MasterControl provides automatic document revision control to ensure that only the current version of an SOP is available. When a user makes a change in the InfoCard (the MasterControl tool that provides basic information for every document record), the user must enter a reason for the change. The software tracks all changes made to the InfoCard.
• Solid Audit Trail: Provides a secure, time-stamped audit trail exceeding 21 Part CFR 11 requirements. MasterControl documents the identity of anyone who creates or modifies an electronic record, when the action occurred, and the changes made.
• Security: 21 CFR 11 emphasizes security practices that limit access to authorized users and holding them accountable for written policies. With MasterControl, documents are stored in virtual vaults located in a central database for access by authorized users only. The software automatically locks both login and approval anytime either one is compromised.
• Advanced Tracking: MasterControl tracks documents by status or history. A document will show as either "in process" or "complete" if tracked by status. The revision or approval history of documents can also be reviewed using the history feature.
• Analytics and Reporting: MasterControl's advanced analytics and reporting capability provides standard and customized reports to help increase management oversight.
• Electronic Sign-offs: With MasterControl, documents can be signed and approved electronically. Signature manifestation name, date, time, and meaning of electronic signature can be appended automatically to each document.

• Manage Different Document Types: MasterControl is uniquely qualified to be the focal point of any compliance initiative because it can manage different documents-based processes and handle all types of documents regardless of the software used to create them.
• Easy Access: MasterControl is Web-based so it can connect all employees involved in document and quality control from virtually anywhere. Provides a centralized repository for easy access, search, and retrieval of documents by all authorized users.
• Automates Routing, Escalation, Approval: Reduces document cycle time by automating routing and approval and incorporating escalation for overdue tasks.
• Dependent Routing: Completion of a task can be made dependent on another task to give managers more control and reduce cycle time by prompting users immediately to their next task.
• Streamlines Collaboration: Creating and revising documents as a team is easier because MasterControl provides a collaboration workspace that allows input from other collaborators, avoiding duplication. A rejected document is automatically returned to the originator for a new task, so rejected packets don't languish in the system.

• Integrates with Other Applications: MasterControl can integrate with other applications like ERP, LIMS, accounting, and human resources applications to accommodate departmental needs.
• Pre-Defined Workflow: Company-wide policies, SOPs, and other documents that require inter-departmental collaboration move along a pre-defined workflow, from one department to the next. Overdue tasks automatically escalate to a manager.
• Automation of Forms-Based Processes: Form processes unique to a department (i.e., application forms for HR, customer satisfaction survey forms for Customer Service Department) can be integrated with document-based processes under one secure repository. A department can keep the look and function of existing forms or create entirely new ones.
• Easy to Search: A standardized "Google-like" search window is available throughout the application, which means all authorized users throughout the organization can search for tasks, training records, policies, and other documents using a familiar search interface.
• Easy to Find: MasterControl's Organizer, similar to Windows Explorer, is an easy-to-use tool that helps users find and access documents quickly. Every department can maintain its own Organizers and documents can be stored in multiple Organizers. System administrators can control and automatically update the documents through a dynamic link in the InfoCard.