Document Control Software - Key Factors


Why is MasterControl Documents™ Right for You?

MasterControl Documents, an integrated part of the MasterControl™ quality management suite, automates and manages document control process in an efficient and cost-effective manner. Here are some of its robust features to ensure your system is always Compliant, Connected, and Complete:

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Compliant.

Sustained Compliance: MasterControl Documents is document control software that not only helps ensure regulatory compliance, but helps sustain it by keeping your quality system constantly prepared for FDA inspections and ISO audits.

  • Revision Control: MasterControl provides automatic 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 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 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.

 

Connected.

Integrated Quality Management: MasterControl Documents connects quality processes under a single Web-based platform to promote continuous quality improvement.

  • 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 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.

 

Complete.

Enterprise-wide Product Application: MasterControl can meet every department's needs to ensure that quality initiatives are enforced across the enterprise.

  • 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.



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