Electronic Document Control


Learn How an Electronic Document Control Solution can Help You Easily Comply with FDA Regulations and ISO Standards

An electronic document control solution helps ensure efficient and compliant production processes. With electronic document control, any change in a process can be restricted to authorized personnel and tracked for future review. Despite the importance of electronic document control solutions, many companies continue to rely on paper-based systems, or on a system for document control management that is only partially automated.


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How Electronic Document Control Solutions can Help You

MasterControl Documents™, an integrated part of the MasterControl quality management suite, provides electronic document control in an efficient and cost-effective manner. Here are some of the features and benefits of implementing an electronic document control solution from MasterControl:

  • Automatic Revision Control: The system for electronic document control software from MasterControl provides automatic document revision control. This ensures that only the current version of a standard operating procedure (SOP) is available. When a user makes a change in the InfoCard (the MasterControl tool that provides basic information for every electronic document), the user must enter a reason for the change. The software tracks all changes made to the InfoCard.

  • Solid Audit Trail: The system for electronic document control from MasterControl provides a secure, time-stamped audit trail exceeding 21 CFR part 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 Part 11 emphasizes security practices that limit access to authorized users and holds them accountable for written policies. With the system for electronic document control software from MasterControl, an electronic document is stored in a virtual vault located in a central database for access by authorized users only. The software automatically locks both login and approval anytime either one is threatened.

  • Advanced Tracking: The system for electronic document control from 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 electronic documents can also be reviewed using the history feature.

  • Analytics and Reporting: The system for electronic document management softare from MasterControl uses advanced analytics and reporting capabilities in the form of standard and customized reports to help increase management oversight.

  • Electronic Sign-offs: With the system for electronic document control from MasterControl, electronic documents can be signed and approved in an automated fashion. Electronic signature manifestation -- including name, date, time, and meaning of electronic signature -- can be appended automatically to each document.

  • Manage Different Document Types: The system for electronic document control from 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 electronic documents regardless of the software used to create them.

  • Easy Access: The system for electronic document control from 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 electronic documents by all authorized users.

  • Automates Routing, Escalation, Approval: The system for electronic document control from MasterControl reduces document cycle time by automating routing and approval and incorporating escalation for overdue tasks.

  • Dependent Routing: With the system for electronic document control software from MasterControl, the completion of a task can be made dependent on another task. This gives managers more control and reduces cycle time by prompting users to immediately begin their next task.

  • Streamlines Collaboration: With the system for electronic document control from MasterControl, creating and revising documents as a team is easy. This is because MasterControl provides a collaboration workspace that allows a user to see other people's input, 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: The system for electronic document control from MasterControl integrates with other applications such as, for example, ERP, LIMS, accounting, and human resources.

  • Pre-Defined Workflow: The system for electronic document control from MasterControl provides pre-defined company-wide policies, SOPs, and other electronic documents. This enables inter-departmental collaboration to move along a pre-defined workflow, from one department to the next. Overdue tasks automatically escalate to a manager.

  • Automation of Forms-Based Processes: The system for electronic document control from MasterControl enables form processes unique to a department (e.g., application forms for HR) to be integrated with document-based processes in one secure repository. A department can keep the look and feel of existing forms or create entirely new ones.

  • Easy to Search: The system for electronic document control from MasterControl provides a standardized Google-like search window that enables authorized users to search for tasks, training records, policies, and other documents using a familiar search interface.

  • Easy to Find: The system for electronic document control software from MasterControl provides an organizer, similar to Windows Explorer, to users find and access documents quickly. Every department can maintain its own organizer. System administrators can control and automatically update the documents through a dynamic link in the InfoCard.

Electronic Document Control Complies with Federal Regulations and International Standards

Electronic document control software from MasterControl complies with federal regulations and adheres to international quality standards. Regulations and standards exist to protect consumers and the public in general. They are a major driving force for companies to manufacture and sell products (or provide services) that are safe, reliable, and effective.

Since 1993, hundreds of companies in a wide range of regulated industries have relied on the MasterControl integrated quality management suite to attain and sustain compliance with regulations and standards:

  • Electronic Document Control from MasterControl Complies with 21 CFR 211 Sub Part B, Section 211.22, c & d - This regulation states that the quality control unit shall have the responsibility for approving or rejecting all procedures or specifications impacting on the identity, strength, quality, and purity of drug product. The responsibilities and procedures applicable to the quality control unit shall be in writing; such written procedures shall be followed.

  • Electronic Document Control from MasterControl Complies with 21 CFR 820 Sub Part C,D,E,G - This regulation requires controls in design, documentation, purchase, and production process. This entails establishment of processes to ensure that a medical device conforms to specifications. Requirements emphasize maintenance of records of document changes, documentation of instructions of production processes and SOPs, and monitoring of process parameters.

  • Electronic Document Control from MasterControl Complies with 21 CFR Part 606 Sub Part F, Section 606.100, b - Written standard operating procedures shall be maintained and shall include all steps to be followed in the collection, processing, compatibility testing, storage, and distribution of blood and blood components for transfusion and further manufacturing purposes. Such procedures shall be available to the personnel for use in the areas where the procedures are performed.

  • Electronic Document Control from MasterControl Complies with ISO 13485 Clause 4 - This standard requires the establishment of a quality management system for medical devices. A manufacturer must have a system for document control and for controlling quality procedures, and be able to demonstrate that this system has been effectively used and maintained.

For More Information On Electronic Document Control Software

For more information on how MasterControl can streamline compliance with electronic document control, please contact a MasterControl representative.