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LabX: Importance of Data Integrity in a GXP Regulated Laboratory
Data integrity is a hot topic for regulators and auditors, so make sure you understand the criteria for data integrity (ALCOA+) and apply them to your laboratory. Avoid the risk of incomplete data, lack of audit trails, and falsification of results occurring during inspections.
What will I learn?
What is data integrity?
Data Integrity definitions:
Why is data integrity important?
Data integrity is a critical component of pharmaceutical product quality and the submission information to regulatory agencies. In recent years an increasing number of inspections have revealed incomplete data, lack of audit trails, and falsification of results.
The US Food and Drug Administration (FDA) issued a stern warning that data integrity was a key focus of its enforcement efforts in July 2014. The UK Medicines and Healthcare Products Agency (MHRA) went further and issued GMP Data Integrity Definitions and Guidance for Industry in January 2015.
As regulators continue to tighten their inspection approaches, it is critical for managers and scientists in regulated GXP laboratories to understand the key issues surrounding data integrity and be able to demonstrate compliance.
This webinar will be of interest to: