MasterControl Documents

MasterControl Documents
Document management and document control 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.

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 organizations 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 management software, but it also provides the appropriate tools and services necessary for successful implementation and validation. Here are some examples of how MasterControl customers are addressing some of the typical major challenges of document management and control:

The Problem
Inefficient 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. Complex Lifecycles: 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 products lifecycle. Disconnected 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.

The Solution
Efficient System: A centralized, secure repository makes search and retrieval easy during inspections and audits. 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. Enhanced Lifecycles: 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. Connected Processes: MasterControl connects 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. Increases 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 the quality system.

Lacks Visibility: Its 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.

Features and Benefits

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 organizations 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 products lifecycle, regardless of complexity or uniqueness. Effective Change Control: MasterControls 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.

web: www.mastercontrol.com

phone: 800.825.9117

email: info@mastercontrol.com

MasterControl Documents

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. Revision Control: Automatic 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 system tracks documents by status (in process, complete) or history. The revision or approval history can be easily reviewed. Analytics and Reporting: MasterControls 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 FDAs 21 CFR Part 11 requirements. Security features include dual passwords for document approval; password expiration, encryption, and certification; and account lockout to stop unauthorized users from gaining system access. Validation: MasterControl also 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 MasterControls unique Transfer OQ. Web-Based Platform: MasterControl is Web-based so it can connect all employees involved in document and quality management 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: MasterControls 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 MasterControls 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 documentsSOPs, drawings, contracts, clinical documents, or any type of submission documentationcan be automatically categorized and updated by the MasterControl system. MasterControl allows users to take organizers to the next levelor as many levels as are required. Product Training: MasterControls Professional Services team 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 MasterControls Education Center in Salt Lake City, or on-site training at customers 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 customers needs, from initial installation to regular maintenance.

2010 MasterControl Inc. All rights reserved. SKU: M1090 REV: 0020

web: www.mastercontrol.com

phone: 800.825.9117

email: info@mastercontrol.com