Data Integrity is not a new issue; indeed, it has been part of WHO, FDA and MHRA guidelines for many years. However, recently, the major regulatory agencies have sought to reinforce the importance of Data Integrity (DI), issuing further guidance and auditing accordingly.
It is not just an “India and China” issue where most FDA Warning Letters and EU Non-Conformance Reports have been issued, as there are well-published accounts of major regulatory findings and sanctions on pharmaceutical manufacturers and suppliers in the EU and USA.
“Verta helps you make certain your data is complete, consistent and accurate, supporting the delivery of high quality, safe and effective products to your patients. We work with you to develop an effective management strategy, including Risk Assessments, comprehensive Root Cause analysis of data integrity lapses and detailed Corrective/Preventative Action Plans. “
Contact firstname.lastname@example.org to see how we can help you ensure Quality and Regulatory Compliance