Learn How to Automate Document Control to Comply with FDA Regulations and ISO Standards
Both FDA regulations and ISO quality standards require companies to establish a system for document control that is electronic in order to ensure product quality and safety.
A document control software system ensures that production processes are all pre-approved, and that changes are restricted to authorized personnel and tracked for future review. Despite the importance of document control and document management, many companies continue to rely on paper-based or paritally electronic system for document control. These systems are plagued by inefficiency and errors that could cause FDA-483 citations or ISO nonconformance.
Experience the Benefits of a Document Control Software System
MasterControl's Document Control Software is an integrated part of the MasterControl quality management suite, automates electronic document management processes in an efficient and cost-effective manner. Here are some of the features and benefits of implementing a document control and management system that is electronic:
- Revision Control: MasterControl provides automatic document control for revisions to ensure 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: A document control system provides a secure, time-stamped audit trail exceeding 21 CFR part 11 requirements. MasterControl provides software for document control that captures 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 hold them accountable for written policies. With our document control software, electronic 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's electronic system for document control and management 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: Our electronic solution for document control uses advanced analytics and reporting capabilities in the form of standard and customized reports to help increase management oversight.
- Electronic Sign-offs: With the MasterControl system for document control, electronic documents can be signed and approved in an automated fashion. Electronic signature manifestation, which includes the person's name, date, time, and the meaning of electronic signature, can be appended automatically to each document.
- Manage Different Document Types: MasterControl's solution for document control 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: MasterControl is Web-based so that it can connect all employees involved in document control from virtually anywhere. The system provides a centralized repository for easy access, search, and retrieval of electronic documents by all authorized users.
- Automates Routing, Escalation, Approval: Our solution for document control 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 document control and reduce cycle time by prompting users immediately to their next task.
- Streamlines Collaboration: Creating and revising documents as a team using our system for document control 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.
- Integrates with Other Applications: MasterControl's electronic system for document control and management 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 electronic documents that require inter-departmental collaboration move along a pre-defined workflow, from one department to the next. With the MasterControl solution for document control, overdue tasks automatically escalate to a manager.
- Automation of Forms-Based Processes: As part of the document control and management process, MasterControl provides form processes unique to a department (i.e., application forms for HR, customer satisfaction survey forms for Customer Service Department, etc.). These forms can be integrated with document-based processes in 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 for document control and management, 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. Document control by system administrators is facilitated by a dynamic link in the InfoCard.