Traditionally, IT compliance within pharmaceutical and life sciences organizations has been viewed through discrete regulatory lenses such as Sarbanes-Oxley (SOX), GxP (Quality), information security, and data privacy. This has often led to a decentralized approach prone to risk management gaps, control redundancies, inefficient allocation of resources, and fewer opportunities for synergies. This report discusses the benefits pharmaceutical and life sciences organizations can realize by shifting from decentralized controls and monitoring functions to an integrated IT compliance framework and monitoring organization.
An integrated and centralized IT compliance framework combines applicable compliance and regulatory controls into a single set of objectives. Having standard controls, a single assessment methodology, and common reporting tools across an organization can increase transparency and accountability.
Pharmaceutical and life sciences have experienced benefits such as:
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