Product Information

CAPA Signs

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Get Back on Track with MasterControl CAPA™ With so many unknown root causes that can steer your CAPA process off course, it's easy to get lost in a maze of CAPA conundrums. MasterControl keeps customers' CAPAs on the right track by effectively managing how issues are input, processed, and funneled into the quality system. The unrivaled MasterControl CAPA solution gives quality professionals a superior methodology and highly collaborative tool to drive continuous quality improvement. MasterControl CAPA gives users: An easy-to-use software solution designed to automate and effectively manage CAPA processes and integrate them with other quality processes, such as change control, audit, training, nonconformance, and customer complaints. • Automatic routing, delivery, notification, follow up, escalation, and approval of CAPAs and all related documentation. • Electronic tracking of routing information and entered data, which makes it easy to identify nonconformance bottlenecks. • Automatic revision control that only makes the most current version of a document available, so users will not make the mistake of using obsolete or unapproved documents. • Seamless integration with the training process: Whenever an important change occurs (in product design, SOP, etc.) training tasks are automatically invoked upon approval of a new CAPA change. MasterControl CAPA Keeps All Departments on Course Customers throughout the world use MasterControl throughout their organizations to guide their skilled professionals through the twists and turns of CAPA navigation. Quality Benefits: • CAPA processes are integrated with the entire quality system, which allows a CAPA form to be launched directly from another form (e.g., customer complaint or nonconformance). • Best practice forms and workflows (including an "8D" process) guide quality teams through every step of CAPA implementation. • A CAPA form can be launched directly from another form (i.e. customer complaint, deviation report), connecting one process to the next while maintaining links so users can review a completed process to see what triggered a process. Regulatory Benefits: • MasterControl ensures that the quality system is compliant and always ready for inspections and audits. • Provides time-stamped audit trail, reporting, and electronic signature capabilities that fully satisfy FDA's 21 CFR Part 11 requirements. IT Benefits: • Web-based platform allows all employees involved in CAPA to stay connected from virtually anywhere. • Offers a broad selection of validation products and services that address different levels of validation needs based on individual risk assessment. • Seamlessly integrates with complementary MasterControl solutions. • Ensures that upgrades are fast, easy, and cost effective. Executives / Management Benefits: • Connectivity with other quality processes creates a "closed loop" approach to management. • Advanced analytics and reporting capabilities include standard and customized reports that can be summarized in multiple levels (i.e., by product, department, and root cause). • Integrates with existing document repositories and enterprise applications like ERP, LIMS, etc., without expensive custom coding. Let MasterControl Steer Your CAPA in the Right Direction MasterControl CAPA simplifies your overall efforts to investigate and correct quality issues to prevent recurrence. • Free Up Valuable Time and Resources: Automate tedious monitoring and trending of quality events and seamlessly escalate them to CAPA when warranted. • Staged Escalation Process: Ensure that resources are focused where they need to be: on the highest risk issues. MasterControl allows for effortless maintenance of traceability and justification for all decisions. • Have You Really Identified the Root Cause: The MasterControl CAPA solution guides users through the collection of relevant data, the proposal of potential root causes, and an evaluation of each one until the root cause is truly identified. About MasterControl Inc. MasterControl Inc. 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/ 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 customers with a complete information management solution across the entire enterprise. Corporate Headquarters: MasterControl Inc. Salt Lake City, UT United States Phone: 1 866 747 8767

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