New White Paper from Astrix Technology Group
Data Integrity in FDA-Regulated Laboratories
What you need to know
Verification of data integrity is a critical part of the FDA’s mission to ensure the safety, efficacy and quality of human and veterinary drugs, biological products, and medical devices. As such, the FDA’s expectation is that all data which is submitted to the Agency is both reliable and accurate.
In this white paper, we will review the FDA's recent draft guidance on data integrity and discuss important steps that your organization can take in order to avoid costly data integrity violations moving forward.