As quality standards continue to rise, regulated companies would be wise to reexamine the compliance management tool they are currently using to make sure it is in line with the latest requirements from the FDA, EMA, and other quality and regulatory authorities. Ensuring effective compliance oversight can be challenging, particularly in today's fluid regulatory landscape. However, there is far too much at stake (e.g., fines, penalties, even imprisonment) to risk noncompliance. Leading organizations - and their stakeholders - are increasingly beginning to realize that automated enterprise-level compliance management tools yield unbeatable business advantages.
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Why is an automated compliance management tool superior to a manual tool? Point-solutions like legacy and paper-based systems fail to identify and address systemic quality problems. Often this is because the data contained in them is siloed, which makes it impossible to seamlessly pass critical information about one quality process (e.g., CAPA event management, change control, etc.) or department to another. As a result, communicating non-conformance data, for example, must be done manually, i.e., entered by hand, which not only results in lost time and resources, but also increases the chances for human error. While all of this is going on, large quantities of product lots are kept on hold awaiting nonconformance status, which greatly impacts the overall costs of production, as well as time to market.
As the above example illustrates, a disconnected, manual compliance management tool compromises a company's ability to achieve a bird's eye view of its entire compliance management process. This lack of visibility hinders the efficiency of the organization, causing quality "blind spots" that can lead to compliance-related penalties, fines, and recalls. Conversely, automated enterprise-level compliance management tools like MasterControl allow you to define, track, manage and report all of your quality processes- everything from CAPA to risk management - across the enterprise in one centralized database rather than having to track those processes across a host of disparate systems. This reduces your cost of compliance, saves your organization money, and increases your competitive advantage.
In today's competitive global economy, your organization's ability to get to market first is crucial. Improved efficiency, the hallmark of automated compliance management tools, is a key factor in the race to market. The faster an organization can implement automated compliance oversight controls, the faster it can achieve compliance success. MasterControl's flexible design ensures rapid installation, implementation, and validation, so you get your compliance management system up and running quickly - and improve your compliance status almost immediately. Moreover, using MasterControl for your compliance needs allows you to more effectively manage potentially brand-damaging (not to mention costly) product shortages or recalls and sustain your delivery of high-quality products.
Now more than ever, consumers are demanding better quality products at lower cost. This puts added pressure on manufacturers to demonstrate product superiority in order to retain its existing customers - and attract new ones. MasterControl is an end-to-end compliance management tool that significantly improves efficiency, accelerates compliance, and reduces cost by helping save users time and effort, all of which helps you deliver better, safer products. Better quality in the enterprise ultimately leads to improved public relations and enhanced shareholder confidence and brand equity, which, in turn will increase your long-term success.
The necessity to adhere to compliance regulations isn't going away and cannot be ignored. However, gone are the days when the impetus for implementing a strong compliance management program was solely to meet legal or regulatory obligations. There has been increasing global awareness that a rock-solid automated compliance management tool can pave the way to better enterprise-wide communication and more streamlined operations, both of which are necessary for organizational survival. Compliance is not just another law (or burden) to comply with; it should be viewed as growth enabler that can lead to tangible business opportunities.
As MasterControl is a leading provider of quality and compliance management software to regulated companies worldwide, MasterControl understands both the regulatory and business drivers that motivate our customers. Our ever-growing product portfolio of compliance management tools includes more the 60 critical, high-value, proven solutions that deliver rapid ROI and accelerate compliance, including document management, audit management, product lifecycle management, training management, bill of materials management, supplier management, and many other compliance-centric products.
To learn more about MasterControl's compliance management tools, and how they can help you gain a competitive business edge, contact a MasterControl Representative