Document Change Management Software Systems


Document Change Management Software Systems and its Critical Role in Compliance

The ability to adapt to change is critical to the success of any business. However, for companies that operate in FDA-regulated or ISO-certified environments, adapting to change and, more importantly, being able to control it, is a necessary part of maintaining compliance. Effective document change control is a complex process, which is why so many regulated organizations are implementing automated document change management software to assist them in their change control efforts. Unfortunately, with so many electronic document change management systems on the market today, choosing the right solution for your business can be a real challenge. There are several factors to consider, many of which are discussed in greater detail in the complimentary information below.

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The Importance of Choosing the Right Electronic Document Change Management Software

Regardless of industry, every regulated company must implement an efficient document change management software solution in order to reduce its risk of noncompliance and ensure the safety and efficacy of its products. But, as many regulated companies can attest, finding the right solution can be daunting given the flood of document change management systems currently populating the market. Before we examine some of the key components to look for in an effective solution, it's important to step back and define the term "document change control."

In regulated industries, change control refers to the process of making modifications in materials, facilities, product design, processes, packing, equipment, computer systems, etc., and then documenting the changes in the form of SOPs, quality manuals and the like. So, essentially, document change control refers to the practice of accurately tracking any changes made to the pre-approved production methods and documentation that directs a company's quality processes. Given the amount of documentation most companies handle at any given time, tracking these changes without the assistance of electronic document change management software would be virtually impossible.

Manual document change management systems, as well as systems that use a combination of both paper and electronic files, are prone to human error, which can lead to product quality problems that result in stringent fines and regulatory penalties. For this reason, and because inefficient document control systems cost regulated manufacturers millions of dollars, selecting the appropriate automated solution is critical. Whether called upon to handle a relatively small change, such as a minor modification in the design process, or required to address a major change, for example, one that is serious enough to halt production, all good automated document change management software systems must be equipped to tackle the challenges discussed in the sections below.

Key Components to Look for in an Electronic Document Change Management Software Solution

Today's best-of-breed quality management systems are designed to handle all processes within the quality system - everything from quality event / CAPA management through change control and training. As you evaluate automated document change management software solutions, it's important to ensure that the system you choose incorporates the following capabilities:

  • Compliance Management Capabilities: In order to transition from a paper-based, manual document control system to an electronic, automated system, manufacturers must follow the guidelines for using electronic signatures and records, as outline in regulation 21 CFR Part 11. These guidelines include: multi-password access and signature, account and intruder lockout, signature manifestation, and change control rationale. During the evaluation process, you should eliminate all document change management systems that do allow for adequate compliance management as required by this important regulation.
  • Document Management Capabilities: Labor-intensive tasks like physically routing documents for approval, storage, and distribution are time consuming, inefficient, and can delay a product's time to market. To be considered best-of-breed, a document change management software solution must have robust document management capabilities, such as audit trail history / record archiving, centralized secure repository, and document cross-linking, which boost efficiency and ensure compliance by minimizing the possibility of error.
  • Revision Control Automation Capabilities: Arguably, one of the best reasons for a company to transition to an electronic document control system is the ability to automate revision control. Document revision control is incredibly time-consuming and error-prone. Finding a solution that can ensure the control of all document versions / revisions, as well as eliminate "rogue documents," adds increased efficiency and accuracy to a company's entire change control process. Revision control capabilities to look for in a document change management software solution include: automatic document routing, approval, and escalation; automatic document replacement (draft to release archive); unlimited pre-determined and ad-hoc routing steps; real-time, repeatable e-mail notification; electronic signature approval history tracking, and automatic document distribution upon approval.
  • Intuitive System Administration Tools: Regardless of how robust a solution is, if it is too complex to manage, the solution's value is diminished. The best document change management software systems are those that provide easy to use system administration tools; tools which not only make managing the entire system comfortable and intuitive, but also minimize the need for dedicated IT resources. These intuitive tools should include: user-friendly route builder capabilities with visual drag-and-drop interface; configurable user rights and roles; automated conversion/publishing to PDF; and advanced system reporting.
  • Intuitive Interface: Successful user adaption depends heavily upon how easy it is for users to navigate a system. Systems that provide users with an intuitive interface promote increased overall system acceptance, and offer a distinctive advantage over document change management systems that do not. Features that can increase user/view usability include: browser-based / thin client access, full-text/metadata searching, and the ability to find documents through graphically linked groupings.
  • Open IT Architecture: Ease of use goes hand in hand with ease of deployment. Users adapt best in an environment that's familiar to them. Therefore, document change management software that provides system administrators with a platform that is easy to deploy and industry proven is preferred. Is the solution you're considering web-based? Does it integrate well with other applications? Does it provide a user-friendly graphical user interface (GUI)? If not, expand your search until you find a solution that can provide you with all of these features.
  • Implementation and Validation Tools: Validation is critical for an organization operating in an FDA-regulated or ISO-certified environment. However, it's important not to make the assumption that all document change management software systems on the market today provide adequate implementation (i.e., training) and validation tools. Before you commit to a solution, ask the provider about the type of training it provides for IT managers, systems administrators, and general users. Ideally, a wide variety of training that takes into account your unique product and industry requirements should be available. In addition, you should ensure that the provider's validation tools and services follow Good Automated Manufacturing Practice (GAMP) guidelines for computer system validation.

Advantages of MasterControl's Electronic Document Change Management Software Solution

For companies operating in FDA and ISO environments, document change control is an essential component to manufacturing products that are safe and reliable. That said, most regulated companies would agree that moving from a manual, paper-based document control environment to one of the many automated document change management software solutions on the market is daunting. Finding a solution that not only includes all of the components mentioned above, but also adapts to your existing business and IT infrastructures requires careful evaluation.

MasterControl's document control offering is a proven, best-of-breed solution that is already helping hundreds of regulated organizations automate and manage every element of the document change control process, and eliminate the common change control errors often cited in FDA 483 observations. From robust compliance management capabilities to superior implementation and validation tools, Web-based and configurable, MasterControl has all of the hallmarks of the most advanced document change management software systems, plus it allows you to connect your organizations document change control process with other quality process to ensure enterprise-wide compliance and product improvement.

For More Information on Document Change Management Software

For more information about document change management software, and how MasterControl can help your company, please feel free to contact a MasterControl representative.