"Remarkably little" case law over the last decade, when electronic signatures began to gain traction, fleshes out legal requirements for their validity, says corporate litigator David Isom of Information Law Group. But the 21 CFR Part 11 provision for them is helping. Several vendors provide e-signature systems, often PDF-based; among them, ISI. VP Ken VanLuvanee says in an interview that while electronic signatures suffice for closed systems, digital signatures--encrypted electronic signatures--are required for use in open systems. ISI currently provides an electronic solution, eCTDXPress, for FDA filings. But VanLuvanee says the company "is having conversations with SafeBiopharma," the life sciences digital signature champion. Article