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