The increasing complexity and continuous changes in the regulatory environment push organizations to seek a more holistic and highly integrated approach to their audit management processes. Auditing is a vital function within a pharmaceutical company nowadays CAPA Management
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To understand how to achieve quality in a regulated industry, you need to know that corrective and preventative actions (CAPA) are essential elements of quality management in GxP environments. The CAPA process is a commonly used tool to achieve operational excellence by identifying and mitigating non-conformances and deviations, both internally and externally.
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Life science organizations developing or manufacturing pharmaceutical products will typically create, maintain and execute large amounts of standard operational procedures (SOP). The solid change control and deployment of SOPs are a fundamental to achieve compliance excellence.
Properly designed Standard Operating Procedures include step-by-step instructions as well as the following:
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Change management is specifically designed to evaluate, redesign, and implement new business processes, where processes are defined in standard operating procedures (SOPs). A well implemented change management pays back into improved business processes, efficient workflows, decreased project overhead, a better risk profile and an improved company culture.
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Post implementation training services often relateto process changes. With biomedion training services implementations are ready for success. The neuronOS Learning Management System (LMS) typically handles the processes related to ramp-up and adoption planning after larger implementations.
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As a common mechanism to discriminate events based on their relevance and to objectively categorize them, concentrating resources and efforts in good quality investigations of the root causes of relevant deviations.
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Audits, safety inspections, engineering surveys, and quality checks are common in life sciences. While they add overheads, they are necessary to keep organizations in business.
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