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MasterControl Nonconformance™

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Data Sheet 1 Data Sheet MasterControl Nonconformance™ In the stringent FDA and ISO environments, a nonconforming product, material, or component could lead to costly rework and scrapping, or worse, a product recall. A product's quality, reliability, and safety depend to a great extent on its conformance to specifications and parameters that have been tested, proven safe, and approved. FDA's Current Good Manufacturing Practice (CGMP) regulations and the most popular ISO standards (ISO 9001, ISO 13485) all require proper disposition of nonconformances. How Can MasterControl Help You? MasterControl Nonconformance is a configurable and easy-to-use solution designed to automate, manage, and streamline the process for identifying, evaluating, reviewing, and handling nonconforming materials, components, parts, and finished products. Here's how it can answer key challenges faced by companies in handling nonconformances. Challenges MasterControl Audit Disconnected Processes: In manual or electronic systems like SharePoint, the reporting of and response to a nonconformance are likely to be disconnected, which could result in delayed resolution. A nonconformance process that's not connected to the corrective and preventive action (CAPA) system could pose serious problems in the timeliness and accuracy of data collection. Connected Processes: MasterControl's best-practice form and five-step process connect all responsible personnel for effective and timely disposition of a nonconformance. The solution offers the choice of maintaining a stand-alone nonconformance process for small-scale, localized incidents, or you may connect it to the CAPA process for automatic escalation when the situation warrants it. Poor Turnaround: A manual system is inherently inefficient. Paperwork may languish in someone's desk, and for a sequential process such as nonconformance, it could mean a delay in resolution of the incident. Fast Turnaround: MasterControl automates data collection, routing, and follow-up of nonconformance cases. The system tracks all active tasks for a user and provides tools for staying on top of things. Approvers can also review and sign electronically. All of these things help shorten cycle time. Challenges and Solutions

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