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Regulators globally have recognized the quality and compliance risks that are caused by a lack of data integrity. UL experts can assess your organization’s current data integrity practices and processes, identify risks, deliver targeted education, and help you build improved, sustainable data integrity processes.
Preparation is essential for any audit because of the escalating complexity and overlap of global quality regulations. Failure to meet audit requirements can severely impact the company, causing delays in product launch. UL partners with companies to develop an inspection infrastructure, processes for hosting and responding to inspections, and education for individuals on how to respond to an inspection.
Companies need to educate their GxP workforce on the latest regulations, so they can apply these requirements into their daily processes and procedures. UL provides educational solutions that enables companies to deliver GxP knowledge across multiple regions consistently and efficiently.
Only a few learning management systems provide training item "version" control, and this feature ensures that QA teams can successfully “up version” an SOP so that it automatically triggers a new training assignment, while also creating a time stamp. That's why FDA-regulated companies should make this a core requirement when evaluating systems.
For the company manufacturing sterlie products, a well-designed competency-based aseptic competency program addresses many business performance issues, such as reduced work stoppages, reduced risk exposure from FDA observations; minimized allocation of time, money, and human resources for CAPAs, and others.
UL’s Risk Management workshops, held in Hyderabad and Mumbai in March 2017, featured several industry leaders who shared insights into the role of risk management in pharmaceutical manufacturing. Download a summary of three critical topics that were discussed: how to remove silos that threaten quality culture, how to build a formal risk-based approach and a "risk office," and how to leverage TQM to improve overall quality.