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MasterControl Field-Based Solutions (FBS) CAPA™

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Data Sheet 1 Data Sheet MasterControl Field-Based Solutions (FBS) CAPA™ If launching a formal corrective action preventive action (CAPA) is the only tool at your disposal to handle quality issues, your company is at risk of experiencing the proverbial death by CAPA – if it isn't already. To avoid this, quality management systems must support an objective approach to triaging quality issues and events. MasterControl FBS CAPA™ is a flexible, configurable best practice process solution that provides you with the option to initiate an issue review to evaluate a quality event using the FBS Issue Review form, or if needed, escalate directly to CAPA using the FBS CAPA form, depending on your company's business risk policies. Because FBS CAPA is built on MasterControl's common platform and integrates with the full FBS Library of process solutions, you can easily assign and launch action items, such as data gathering as part of your root cause investigation or specific remediations as part of your CAPA plan. You can also initiate any required document revisions directly from the FBS CAPA form. And thanks to the interconnectedness of MasterControl's process solutions, all actions taken to address a quality event and the rationale behind them are automatically recorded and tracked in the system, providing a digital audit trail that streamlines the audit process. Development Clinical Regulatory Quality Supplier Manufacturing Postmarket Cx Rx Qx Sx Mx Px Dx

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