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To effectively manage compliance risk in today’s world of dynamic regulatory change, pharmaceutical organizations need to have visibility.
FREMONT, CA: Pharmaceutical firms operate in one of the most dynamic environments. Customer expectations are changing, and markets are transforming. Companies are struggling to drive rapid innovation without compromising their regulatory integrity. Changes in compliance by regulatory bodies like the US Food and Drug Administration (USFDA) has increased the significance of compliance management for drug manufacturers. Pharma businesses across the globe are compelled to alter their compliance practices to conform to changing regulations. The regulatory bodies across the globe are forcing pharma and life sciences companies to identify quality issues before they impact production.
Traditionally the pharmaceutical industry has been dealing with malpractices ranging from improper branding to masking safety information and disregarding quality manufacturing standards. This has led to regulators keeping a strict watch on the pharma companies. Enforcement agencies have become more active, and any violation of compliance of standards could affect the company’s reputation, risking its future. Compliance audits and inspections can represent major costs for pharma businesses. The best way to reduce this cost is by implementing a continuous readiness model. This can drastically enhance the efficiency of compliance programs and help prevent non-compliance.
Pharma organizations should always seek new opportunities to invest in compliance functions that touch on different business areas, including regulatory policy changes, supply chain, and data management. Additionally, companies across the globe are investing more time and resource in big data, hoping that it will mitigate their non- compliance issues. Being able to access data in real-time is the most effective way to monitor regulatory signs and compliance changes.
As regulatory changes continue to evolve, the industry must adapt and evolve while maintaining a swift pace of innovation to meet the expectations of customers across the globe. Now is the time for pharma companies to realign their compliance strategies with the wider interests of the organization.
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