Quality Management (QMS) Solutions

Quality Management (QMS) Solutions Are A Strategic Priority

Regulated companies worldwide are demanding a better way to manage their quality processes. A recent survey conducted by AMR Research on the top software components for organizations shows that quality management solutions top the list as a strategic priority. What's more, of the 350 life science companies surveyed in 2011 by an industry-leading global regulatory business news publication, 50 percent report having already switched from hybrid or paper-based quality management systems to electronic QMS solutions. If your organization is still relying on a hybrid or paper-based system to meet its compliance challenges, you are at competitive disadvantage. As a leading global provider of quality and compliance software, MasterControl is helping many regulated companies successfully transition to automated quality management solutions. Read about the best practices we have learned by downloading the information below.

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Why Regulated Companies are Implementing Electronic Quality Management Solutions

Why are electronic QMS solutions in such demand? Today, more than ever before, life science and general manufacturing companies are facing mounting regulatory pressures from the FDA, EMA, ISO, and other global regulatory agencies. This ever-increasing regulatory oversight coupled with growing customer demand for safer, more effective products, has propelled automated quality management solutions from an afterthought to a strategic requirement.

Regulated companies that do not deeply embed electronic quality management into their manufacturing and value chain operations weaken their competitive standings in the market and expose their brands to great risks and highly publicized recalls. In progressive companies, managers recognize that switching from hybrid or paper-based QMS solutions not only enhances organizational output and productivity, but also supports the next generation of quality management, which is driven by both the need to satisfy regulatory requirements and the genuine desire to improve product quality and safety. Some of the benefits of MasterControl's electronic quality management solutions include:

  • The cost of compliance is reduced: Rather than having to track your organization's quality process from a host of disparate systems, MasterControl's QMS solutions allow you to define, track, manage and report all of your quality processes, such as document management, CAPA, risk management, supply chain management, audit management, and training, in a single, centralized database. This not only increases your competitive advantage, but also reduces your cost of compliance.
  • Lengthy implementation and/or validation timeframes are avoided: Out-of-the-box and configurable, MasterControl's quality management solutions are able to accommodate your organization's existing business and IT infrastructures - unlike other quality solutions that require custom coding or lengthy implementation and validation timeframes. With MasterControl, you get your quality system up and running quickly, which means you start meeting your compliance goals almost immediately.
  • Risk to brand and corporate image are minimized: Using MasterControl's software to monitor your quality process enables you to more effectively avoid or minimize costly and embarrassing product shortages and/or recalls. Ultimately, this leads to increased brand equity as well as increased customer retention.
  • Delivery of better quality products is achieved: MasterControl's electronic QMS solutions help you reduce costs, increase efficiency, and reduce risk within your organization while helping you to achieve and maintain your required regulatory agenda. These benefits, which all effective software solutions should provide, result in the production and delivery of higher quality products.

What Sets MasterControl Quality Management Solutions Apart from Other QMS Solutions

MasterControl is a leading provider of quality management solutions to regulated companies worldwide. Unlike less flexible software, MasterControl been designed to integrate with other enterprise systems, ERPs, for example, quickly and easily. What's more, MasterControl allows you to create a unified method for managing all of your critical compliance requirements, from training and supplier management to processes and documentation, across the entire enterprise. Over the years, our product offerings have grown tremendously. Currently, our software portfolio includes more than 60 tools to help regulated companies save time, save money, and improve efficiency. With robust, integrated QMS solutions from MasterControl, you can manage all of your quality process including:

  • Supplier Management - Globalization, increased product complexity, outsourcing, and expansion into emerging markets have prompted the FDA and regulatory agencies around the globe to look more closely at how manufacturers manage their supply chain. Yet many electronic quality management solutions on the market today lack an effective tool for supply chain management. MasterControl Supplier™, an integrated component of the MasterControl quality suite, differs from other solutions in that it offers a single repository for accessing all of your supplier quality data and documentation, such as nonconformances, audit observations, contracts, and service level agreements. The simple user interface makes adding and tracking parts and suppliers easy. Robust quality sytems like MasterControl are able to link approved parts, materials, and services directly to a specific supplier and readily available for status review. All of this information is obtainable via MasterControl's built-in reporting tool, which allows you to filter and trend data relevant to each supplier. The audit process, related findings, and supplier corrective actions are managed through to completion. As far as QMS solutions go, it truly is one-stop shopping.
  • CAPA - The corrective action and preventive action (CAPA) process, the crux of any quality system, has been a major quality management issue for years. Corrective actions and preventive actions are a set of policies and procedures that an organization must follow to get to the root cause of a problem or event and to ensure that the appropriate actions are taken to rectify and avoid the problem or event in the future. The amount of open CAPAs an organization has is closely scrutinized by the FDA and other regulatory agencies, and there are many quality management solutions on the market today that have been developed to address this critical QMS issue. MasterControl CAPA™ is an easy-to-use software solution designed to automate and effectively manage the CAPA process and integrate it with other quality processes, such as audit, training, customer complaints and change control, for a holistic quality management. Robust QMS solutions like MasterControl CAPA can simplify this crucial, and often times highly complex, process.
  • Risk Management - Risk management and risk assessment tools are not new to quality management. Both have prompted the creation of numerous quality solutions designed to streamline and integrate quality-related risk activities and strategies. However, few QMS solutions offer what MasterControl Risk™ offers: a "one-stop-shop" that unifies all risk-related activities and documentation in a single, centralized repository. MasterControl Risk provides a complete and accurate picture of the risk landscape across product lines, business processes, and business units, precluding reputation damage from recalls of regulatory action. Effective quality management solutions like MasterControl Risk provide risk management capabilities in addition to managing the audit and CAPA processes.
  • Training - Improper or incomplete employee training can lead to actions which cause non-compliances and result in stiff fines and penalties. Keeping your workforce well trained - and being able to document that training - is a critical success factor for maintaining compliance in any regulated company. MasterControl Training™, one of MasterControl's flagship QMS solutions, automates the routing, tracking, documentation, training, and retraining of training tasks enterprise wide. Whenever there's a change in an SOP or other document linked to a course, all affected employees receive new training tasks and notification via email. Because training has become such integral part of compliance with the FDA, OSHA, and other regulatory agencies, effective quality management solutions like MasterControl Training are crucial to regulatory success.

For More Information On Quality Management (QMS) Solutions

Please feel free to contact a MasterControl representative about questions you may have about our quality management software solutions.