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By Donald C. Singer

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Electronic signatures using biometrics must be designed to be unique to their owners. The electronic system is based on at least two distinct identification components, such as an identification code and password. Typically LIMS applications have a log-in event consisting of a user name, initials, or identifier, as well as a password. The execution of one of the two electronic signature components may constitute a log-in. Another identification code is needed for a valid electronic signing. During a continuous data recording session, all signings need only be verified by one component of the electronic signature.

The document outlines control of electronic records in closed and open computerized systems. Signature and record linking is addressed. Electronic signature components and controls are defined as well as controls for identification codes/passwords. The 21 CFR 11 document enhances the GALP with guidance on electronic signatures and the types of systems they can be implemented on. Valid electronic signatures used in a LIMS system ensure development of a compliant, paperless system. The 1998 FDA Guide to Inspections of Computerized Systems in the Food Processing Industry discusses inspection of computerized systems, particularly in the food processing field.

Historically, the use of black ink was directed to ensure that copying was complete. Other colors are now also acceptable as they are copied completely with newer equipment. Some 32 Part II: Critical Laboratory Operations companies require the use of inks other than black to denote an original signature, especially for approvals by the quality function. Be aware that the use of liquid ink will seep through the page and may obliterate data on the reverse side or become illegible. The identity of the individual making the entries must be traceable and unambiguous at all times.

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