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.
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.
Ensure awareness of ethical standards and code of conduct.
Model and manage risk
Manage uncertainty and the unexpected risk with robust systems.