Ensuring Integrity and Security of Laboratory Data

This webinar will provide a comprehensive understanding of the key FDA/EU requirements for integrity and security of laboratory data and offer recommendations and tools for effective implementation.

Why Should You Attend:

The FDA has found and reported multiple cases where companies manipulated electronic laboratory records to bring out-of-specification results into specifications. Since then FDA inspectors have focused during GLP, GCP and GMP inspections on security, availability, accuracy and integrity of 'complete' laboratory records. The FDA has trained inspectors to identify data falsification and recommended the same to industry QA departments and auditors.

In the last three years alone, the FDA issued over 30 warning letters and 483 form inspectional observations related to electronic records. The industry is unsure how to comply with FDA inspection requirements.

This webinar will provide a comprehensive understanding of the key FDA/EU requirements for integrity and security of laboratory data and offer recommendations and tools for effective implementation.