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Data integrity requirements are not new. FDA, MHRA, and WHO have generated additional guidance to clarify requirements. Why? Numerous violations have been found in recent years that have led to warning letters, import alerts, and consent decrees.
Data Integrity Issues
• Data integrity issues can happen because of unintentional and deliberate behaviours and actions
• Unintentional issues are often the result of poorly designed processes and procedures, mistakes or lack of understanding.
• Deliberate issues are actions to deceive or mislead. These often occur as a result of trying to hide or cover up a mistake or issues. These include:
• Falsification of data, e.g. backdating documents, signing for actions not completed or witnessed
• Omissions or deletion of data
• It is ALWAYS better to explain mistakes or problems openly so they can be resolved quickly and accurately.
• Whether the data integrity issue is unintentional or deliberate, it impacts the safety and quality of our products.
• Even good intentions can lead to poor data
