e-Signature White Paper

Pharmaceutical companies are commonly driven by:

• Getting new drugs to market as quickly as possible
• Making the manufacturing process as efficient as possible
• Maintaining high levels of quality control
• Improving customer satisfaction.

All of this must be achieved while complying with a multitude of regulations: GLP, GMP, GAMP, GCP, PDMA and 21CFR Part 11.

Appropriate adoption of computer systems contributes to the achievement of all of these objectives, and many pharmaceutical companies have started to use computer applications in critical parts of their business, including:

		Discovery databases
		Data capture in clinical trials
		Clinical data management systems
		Document control (e.g. for management of SOPs in manufacturing)
		Batch process control
		Training
		Detailing

As pharma is a tightly regulated industry, there is a need to properly authenticate people so as to control access to systems and provide audit trail. There is also a need to authenticate people to allow them to electronically sign off on processes. The need for authentication exists throughout the value chain - from molecule to mouth. This document examines the nature of this requirement and explains how Daon's product meets that need.

Download Biometric Authentication & Digital Signatures for the Pharmaceutical Industry (2.2MB pdf)