Assuring EMA, FDA and MHRA data integrity

A Nudge In The Right Direction

The challenge of EMA, FDA and MHRA data integrity should be looked at in the context of good governance and the management of risk and compliance: a system-level response to a system-based problem.

Our white paper discusses the implementation of effective behavioural, procedural and technical steps and systems to ensure data is accurate, consistent and reliable throughout the lifecycle.

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Key Takeaways

Modernise your operational processes

Improve operational processes through digitalisation.

Strengthen internal controls

Adopt a risk-based approach to quality control and inspection.

Eliminate obsolete systems

Ensure the quality management system (QMS) is adequate.

Manage competence

Ensure awareness of ethical standards and code of conduct.

Model and manage risk

Manage uncertainty and the unexpected risk with robust systems.