The provider of quality management systems in regulated environments offers a software system to manage the entire CAPA process according to FDA and ISO best practices
MasterControl, the developer and provider of total quality management systems, has created a software solution designed to aid companies in regulated environments and ensure they meet the requirements of the FDA and ISO. This corrective action software can be implemented in different industries and has the potential to improve product quality and safety.
Large companies can face major difficulties remaining compliant with industry-specific regulations while they continue to grow. CAPA software in these instances must be integrated with other quality processes throughout the company, including change control, document management, training, audits, and customer complaints.
In enterprise-level companies, all of these processes can conceivably initiate a corrective action. When this happens, the right department must be informed of the need and every action they take to rectify to problem must be carefully tracked and recorded. MasterControl’s solution was designed to address some of these challenges and make sure the company remains compliant with regulatory standards.
MasterControl’s software systems include a number of features to assist companies. It provides best-practice electronic forms and workflow routes that companies can customize to meet their individual needs, and the software interconnects with all the quality subsystems. This makes it possible to track quality incidents that lead to a necessary corrective action. There is also an advanced analytics and reporting system that monitors the entire management lifecycle so reports can be generated when necessary.
The MasterControl CAPA software system automates many of the normal processes that would normally require a large investment of time and money to accomplish. The connected systems and reporting capabilities of the MasterControl system are making it possible for companies to gain the oversight they need to maintain regulatory compliance and take their products to market.
produces software solutions that enable companies doing business in regulatory environments 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. MasterControl software is known for being easy to implement, easy to validate and easy to use. MasterControl solutions include quality management, document management/document control, product lifecycle management, audit management, training management, 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. For more information about MasterControl, visit www.mastercontrol.com, or call: 800-825-9117 (U.S.); +44 (0) 1256 325 949 (Europe); or 03-6801-6147 (Japan).