Document Control Software Systems
MasterControl Documents™ - Document Control Software Systems for 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. Document control software systems streamline these vital quality processes.
MasterControl Documents™, document control software systems, is a core application in the MasterControl™ integrated business quality & process management suite that 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.
How MasterControl Makes Your Job Easier (3:50)
Creating a Paperless Process Using MasterControl (3:38)
MasterControl's Documents Module (2:02)
Document control software systems must be validated in FDA environments 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. MasterControl’s unique approach to validation—which includes the revolutionary Validation TOQ offering—eases validation pains for companies doing business in regulatory environments by making validation of software upgrades easier, faster, and more cost-effective.
How our Document Control Software Systems can Benefit You
Document control and document management are essential to maintaining quality and compliance. To effectively control quality, an organization must control quality documentation, such as SOPs, policies, quality manuals, CAD files, engineering change orders, etc. Here's how MasterControl Documents™ addresses some of the major challenges that companies face in managing and controlling documents.
The Value of a Connected, Compliant Document Management System
When document control is seamlessly connected with other quality processes, compliance and overall improvement are continually promoted. Continuous compliance ensures that an organization’s quality system always ready for inspections and audits. MasterControl Documents™, a core application in the MasterControl integrated business process management suite, automates and effectively manages the document control process to help ensure compliance with FDA regulations, ISO quality standards, and other regulatory requirements. Not only does MasterControl offer robust document control and document management software, but it also provides the appropriate tools and services necessary for successful implementation and validation.
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 Systems 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 Systems that we offer provide automatic revision control to ensure that only the current version of a document is available. Changes can be initiated and approved electronically. MasterControl automates routing, delivery, escalation, and approval of documents. It can also handle all types of documents regardless of the software used to create them. MasterControl Documents always ensures that users are able to access the right document any time.
|Complex Document Control Lifecycle
Product documentation usually has a complex lifecycle with complicated workflows and routing. Inflexible systems may force companies to use a lifecycle that does not model their own product’s lifecycle.
|Enhanced Document Lifecycle
MasterControl allows for multiple lifecycle statuses, timed lifecycle movement, and flexible approval rules. Companies are able to model their product lifecycle within the system and simplify routes and workflows.
|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|
MasterControl Document Control Software Systems connect 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 Systems that we offer provide advanced analytics and reporting capabilities, 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.
Document Control Software Systems -- 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
Document Control Software Systems -- 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
Document Control Software Systems -- Main Features
- Compliant Document Control Software System: MasterControl allows continuous compliance by keeping an organization's quality system always ready for inspections and audits.
- Automated Routing, Escalation, and Approval: Reduces document cycle time by automating routing and approval and incorporating escalation for overdue tasks. Automation helps sustain compliance by simplifying and streamlining processes.
- Multiple-Step Lifecycles: Users can configure lifecycles with multiple statuses or phases. This functionality perfectly aligns with an organization’s processes to simplify workflows and routes and reduce “vault bloat” in systems since vaults can be tailored to teams and departments rather than document types. Combining flexible approval rules with lifecycle phases makes it simple to model a product’s lifecycle, regardless of complexity or uniqueness.
- Effective Change Control: MasterControl's change control functionality allows users to track the changes between revisions of an item in the MasterControl system.
- Autoload Feature: Allows users to drag and drop new documents into preconfigured network folders, making document creation infinitely easier. MasterControl can even automatically launch a collaboration for the new document or send it automatically on the appropriate approval route.
- InfoCard Metadata Linked to Document: This feature helps eliminate a common problem with out-of-synch metadata during the revision process. When revising a Microsoft Word document, updated information such as document number and revision number can be automatically transferred to the document header from the InfoCard, the MasterControl tool that provides basic information about a document.
- Document Revision Control: Automatic document revision control ensures that only the current version of a document is available, so users will not make the mistake of using obsolete or unapproved documents.
- Advanced Tracking: The Document Control Software Systems that MasterControl provides tracks documents by status (in process, complete) or history. The revision or approval history can be easily reviewed.
- Analytics and Reporting: MasterControl's advanced analytics and reporting capabilities provide standard and customized reports to help increase management oversight. It includes dashboard, drill-down, and scheduling features.
- Part 11-Compliant Features: MasterControl provides time-stamped audit trail, reporting, and electronic signature capabilities that fully satisfy FDA's 21 CFR Part 11 requirements for document control software systems. Security features include dual passwords for document approval; password expiration, encryption, and certification; and account lockout to stop unauthorized users from gaining system access.
- Connected Document Control System: MasterControl connects the document control process with other quality processes to promote continuous improvement.
- Web-Based Platform: MasterControl is Web-based so it can connect all employees involved in document and quality control from virtually anywhere.
- Word Integration: Word 2007 users can connect to MasterControl directly from Word to access documents located in their open collaborations, search for documents, check documents in and out, and easily start a new collaboration.
- Integrates with Other Applications: MasterControl integrates with systems like ERP, LIMS, accounting, and human resources applications to connect different departments and operations within an enterprise.
- Organizers: MasterControl's Organizer, similar to Windows Explorer, is an easy-to-use tool that helps users find and access documents quickly. Users will usually have access to Organizers related to their jobs, connecting them directly with data they need. Document-level actions allow users to work on a document without leaving the Organizer. Users can view both native and PDF versions of a file, check it in or out, or create a copy or external link, all from the Organizer. External and view-only users can have access to Organizers via external links. Clicking the link opens an Organizer in a browser window that is independent of MasterControl's navigation menus and search functions.
- Taxonomy Organizers: MasterControl Taxonomy Organizers™ allows each group within the enterprise to have its own unique taxonomy with the capability to have a single document exist in one or more taxonomies. Critical documents - SOPs, drawings, contracts, clinical documents, or any type of submission documentation - can be automatically categorized and updated by the MasterControl system. MasterControl allows users to take organizers to the next level - or as many levels as are required.
- Complete Document Control Software System: MasterControl offers robust software plus the appropriate tools and services necessary for successful implementation and validation.
- Validation: MasterControl offers a line of validation products and services that address different levels of validation needs based on individual risk assessment. These validation offerings are designed for companies doing business in regulatory environments to make software validation upgrades easier, faster, and more cost-effective. The continuum of innovative products and services includes MasterControl’s unique Transfer OQ.
- Product Training: MasterControl's Professional Services team, consisting of former ISO auditors and system administrators, has developed a comprehensive training program that serves as a foundation for successful project implementation and helps companies realize software ROI faster. Customers have the choice of recorded training courses, live training at MasterControl's Education Center in Salt Lake City, or on-site training at customer's facilities.
- Technical Support: Choosing MasterControl means getting the necessary technical support to ensure project success. MasterControl offers the expertise, infrastructure, and flexibility to meet every customer's needs, from initial installation to regular maintenance.
For More Information on Document Control Software Systems
For additional details about the Document Control Software Systems from MasterControl, please feel free to contact a MasterControl representative.
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