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CAPA (corrective and preventive actions) are very integral part of any quality management system for Pharmaceutical industry. Effective CAPA ensures that the company is constantly working towards reducing the weakness, failures in the production and / or testing of drugs and digging deeper for investing the root causes and then learn and improve from these causes. CAPA empowers the organization to prevent the recurrence of the problem, correct the existing nonconformity of products or quality issues. If the FDA auditor will not satisfy with your system to manage CAPA can cost you warning letter or penalty. CAPA automation software solves all these hassles.
Different company has different perception about CAPA , some think this is the task given to them to complete in order to “stay compliant,” while others look at CAPAs as a number based metric that needs to be reduced. But the actual meaning of CAPA is effectively managing the complete life cycle in simple words a system which provides the tools for the identification, evaluation, and investigation of a deviation, but also the tools to determine, implement, and check effectiveness of a resolution. CAPA empowers a quality system to be self-correcting.
Most of the companies use manual paper based system for managing CAPA and face below mentioned complexities:
QEdge has been specially designed after experiencing the industry wide requirement to effectively manage the corrective and preventive action process and integrate it with other quality processes for attaining compliance.
QEdge – CAPA automation software solution helps organization to make sure all measures, identified in the past to solve issue or complaint related to quality are take care off and helps to make sure that same types of issues are not repeated. QEdge provide a single unified platform for electronically identify, evaluate, investigate and analyze the incidents. The closed loop quality management system within QEdge allows users to create change management through change control or CRF and monitor the same. CAPA would not be closed unless the change control associated with CAPA are confirmed to be closed.
How QEdge – CAPA automation software can benefit you:
QEdge Quality Management Software Suite
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