Andrea K. Kerrigan, FDA, outlines how validation, data integrity, and QRM determine whether digital tools and AI strengthen or undermine CGMP compliance.
|Articles|July 21, 2016
Secure Document workflows in Drug Development
Author(s)DocuSign
Intensified regulatory scrutiny of data and reporting has increased demand for authentication of documents used in bio/pharma development and manufacturing. Mollie Shields Uehling, CEO of SAFE-BioPharma an association working to provide high-assurance identity trust for cyber transactions, describes the role digital signatures can play in ensuring the integrity of documents used in drug development and manufacturing processes. The discussion includes applications for digital signatures in pharma research, development, and manufacturing; regulatory requirements for document authentication; and how digital signatures can improve document authentication and workflow within organizations and when collaborating with external partners.
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