With the global market reach of most large Pharma, together with their widely distributed operating units, companies are challenged with implementing efficient workflows and quality processes that ensure global regulatory compliance and inspection readiness. This is especially so in Safety and Manufacturing, where multiple local and regional processing units need to collaborate to process safety data or produce the final marketed product. Safety departments, with limited resources at local country offices, face challenges in the efficient and compliant handling of inbound safety data and outbound regulatory submissions. In the absence of well-defined global processes and shared reference systems, local units may adopt varying and disconnected systems for processing reported safety issues. This may potentially lead to shortfalls or delays in safety reporting, resulting in findings of non-compliance during audits and inspections. In addition, in the absence of a facilitated central compliance monitoring capability across distributed local offices, companies face challenges with ensuring global compliance on the one hand, and implementing corrective and preventive measures at the right company units on the other.
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