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Feb 25, 2016

Curing Document Control Conundrums: A Checklist for Sustained Efficiency and Audit Readiness


If a document control system exists to improve your organization’s productivity and help maintain a continual state of audit readiness, what rudimentary features does it absolutely need to have? The components that are deemed essential may vary slightly from one organization to the next based on individual business requirements, but the following checklist covers the minimum functionality that should be expected from a categorically complete document control software solution.


  • Tracks and organizes documents electronically: When you are facing an audit or a review, it is imperative that you have access to the precise document you need, exactly when you need it. If you find yourself frequently hunting through file cabinets, old spreadsheets or other employees’ desks to dig up the most current version of the document you need, your document control system isn’t up to snuff. Paper or hybrid paper/spreadsheet document control systems just aren’t cutting it in an era where instant access to data is expected.

  • Automates the routing, delivery, and escalation of documents and includes flexible approval rules: When documents get into the hands of required personnel faster and collaboration times are accelerated, bottlenecks can be identified sooner and cycle times can be reduced. Automation dramatically streamlines these processes, especially if it allows for flexibility in document approval progressions.

This article is related to the White Paper: Automating Document Control Processes. To get the full details, please download your free copy.

  • Handles all document file types: A format-agnostic document control system can handle any file that is particular to your business requirements (CAD files, videos, Word documents, spreadsheets, audio files, etc.) regardless of the application used to create it.

  • Manages documents according to regulatory standards: If your organization does business in regulatory environments and is subject to international standards of quality, your document control software system needs to include time-stamped audit trail, reporting, and electronic signature functionality that fully satisfies those regulatory guidelines. The time, effort and costs required for the validation of their document control software systems are also important considerations for companies with regulated products.

  • Provides an effective collaboration workspace: Connecting teams through an electronic document control system allows them to execute tasks efficiently, accurately, and on time. A virtual collaboration workspace allows each collaborator to view the contributions of other team members instantaneously rather than just provide isolated input.

  • Ensures a single, current source of truth: Automatic revision control provides the assurance that only the most current version of a document is available and prevents users from using obsolete or unapproved documents.

  • Features archival functionality that provides clearly delineated revision and approval history records: A centrally accessible repository for document vaults makes the search and retrieval of documents a snap during audits or inspections. The system is even more beneficial if it can readily track documents by status (i.e., in process, complete, etc.) or history and if the revision or approval history is easily reviewable.

  • Promotes effective lifecycle management: If product lifecycles are to be managed effectively, routes and workflows must be as simple as possible. And, since a company’s workflows revolve around its products (and not vice versa) the document control system in use must make allowances for multiple lifecycle statuses, timed lifecycle movement and flexible approval rules. When vaults are tailored to teams and departments, rather than to document types, it helps eliminate “vault bloat.” Organizing document vaults according to the way your company does business gives direct access to the specific data you require exactly when it is needed most.

  • Provides mobile access to a Web-based system: Authorized users need to be able to access vital documents from any geographic location, at any time, and from any device.

  • Integrates all paths between each quality process: No quality process exists in a vacuum. A change to one quality document inevitably affects another quality document or process. An effective document control software system connects quality processes like change management, audits, corrective and preventive actions (CAPA) and training. Making the system fully electronic will dramatically streamline all these connected processes (e.g., an update to an SOP can be set to automatically trigger a new training regimen, etc.).

  • Includes reporting and analytics functionality: Different document control software vendors offer reporting features of varying levels of depth and complexity, but at least some degree of reporting functionality is necessary for management oversight. Dashboards, drill-down functionality, customizable reports, online charting, and scheduling features are some of the analytic components that can help increase visibility into document control processes.

An effective document control software system can enable your company to increase productivity, sustain compliance, and maintain a continual state of audit readiness. For more information, watch this informative video to learn how a robust document control software solution can benefit your organization.



James Jardine is a marketing communications specialist for MasterControl Inc. He has a bachelor’s degree in journalism from the University of Utah and is based in MasterControl’s headquarters in Salt Lake City, Utah.








Watch Related Videos:

Creating a Paperless Process Using MasterControl
How MasterControl Makes Your Job Easier


Download Free Resources
White Paper: Automating Document Control Processes
White Paper: Reducing the Documentation Burden in FDA Design Control
Product Data Sheet: MasterControl Documents™
White Paper: SOP Management as a Compliance Tool in FDA and ISO Environments


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