Data integrity remains a perennial hot topic impacting the pharma biotech industry and the trend has been picking up steam; the number of data integrity-related warning letters has increased consistently since 2010. A number of new guidance documents came out in 2016 by FDA, MHRA, EMA PIC/S and the WHO and yet companies continue to grapple with data integrity issues.
NSF conducted extensive research into warning letters issued from 2005 to 2017 for data integrity deficiencies. In this white paper, George Toscano takes a deeper look into where companies were struggling most and provides some essential advice. It also includes a European perspective on data integrity issues from expert Lynne Byers.
Read the complete white paper here
George Toscano has more than 20 years of experience helping companies in the global pharmaceutical, biologic and biotechnology markets develop and execute comprehensive quality systems solutions. He is a recognized data integrity expert and has conducted numerous audits and assessments to evaluate companies’ systems. In addition, he has led remediation activities related to data integrity deficiencies to help clients address regulatory enforcement actions.
As Vice President of Quality Systems, Mr. Toscano assists companies in the pharmaceutical, biologic and biotechnology industries, both foreign and domestic, in developing compliant quality and regulatory strategies. He also specializes in conducting GMP assessments of facilities and support to help companies address quality system deficiencies.