The purpose of document control systems is to ensure that manufacturers build products that are safe and reliable. ISO and FDA Current Good Manufacturing Practices (CGMPs) presume that both the process and documentation that directs company processes follows pre-approved methods and that any change to these methods is restricted to authorized personnel and tracked for future review. All FDA-regulated and ISO-certified companies are mandated to have a document change control system.
Inefficient document control systems cost FDA-regulated manufacturers millions of dollars. This significant loss in revenue can primarily be attributed to the inefficiencies that occur when using a paper/hybrid-electronic system (wherein document change control is managed in a manual fashion or using a combination of both paper and electronic files.) Manual systems are error-prone, delay a product's time to market, and introduce product quality problems that can result in stringent regulatory penalties. In fact, the FDA cites inadequate change management as a major cause for "Form 483" observations. Examples of common shortcomings include documents with missing dates or missing numbering schemes, uncontrolled copies and document changes without approvals or explanations. To eliminate these inadequacies, regulated companies are turning to electronic-based quality management systems.
Today's quality management systems provide integrated solutions to handle everything from corrective /preventive actions (CAPA) through change control and training. This article will focus on document control processes within the quality system lifecycle and provide insight into the capabilities needed to automate change control processes that will increase efficiency, ensure compliance with FDA requirements and improve overall profitability.
To eliminate the problems FDA-regulated companies are being cited for during inspections and audits, a change management / change control software solution must incorporate the following capabilities:
In order to move from a manual, paper-based system to an electronic, automated system, manufacturers must follow the guidelines outlined in regulation 21 CFR Part 11 for using electronic records and signatures. These guidelines include the following:
Document management capabilities boost efficiency and ensure compliance by eliminating labor-intensive tasks like physically routing documents for approval, storage and distribution.
Document revision control represents one of the most time-consuming tasks and one of the tasks that is ripe for automation. When automating document control processes, users will find that with the right solution they can accomplish the following:
FDA-regulated companies looking for document control, change management or change control systems should search out applications that have complete services for implementation and validation.
FDA-regulated companies would agree that moving from a manual, paper environment to an electronic system for document control and change management is challenging. It is an endeavor that includes costs for upgrading IT infrastructures (if necessary), the training of users and the validation of the system. However, most, if not all of the companies that have made the transition can prove that the benefits of automation include a faster return on investment (ROI). More importantly, the automation of these change control tasks eliminate common errors that are cited in FDA 483 Observations yielded by companies using manual, paper-based/hybrid-electronic systems.
Jason Clegg is Marketing Director at MasterControl Inc. MasterControl produces software solutions that enable regulated companies to get their products to market faster, while reducing overall costs and increasing internal efficiency. MasterControl securely manages a company's critical information throughout the entire product lifecycle. Our software is known for being easy to implement, easy to validate and easy to use. MasterControl solutions include quality management, document management, product lifecycle management, audit management, training management, document control, bill of materials, supplier management, submissions management, and more. Supported by a comprehensive array of services based on industry best practices, MasterControl provides our customers with a complete information management solution across the entire enterprise.
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