Electronic Laboratory Notebooks Requirements, .PPTVIP

Digital Signatures with digital timestamps offer a major advantage: Any change to a signed document will invalidate the digital signature and timestamp Thus, the validity of the signature and timestamp itself provides evidence that the document has not been altered How was the record maintained, and has it changed? (cont’d) * An ELN employing true digital signatures and timestamps should satisfy the requirements of admissible evidence, but it’s a sliding scale Legal Requirements - Conclusions * Improve chances of success by: Digital signatures and timestamps, using (PKI) or equivalent A reputable and widely-used Certificate Authority and Timestamp Authority Strong user authentication Controlled access to stored documents People knowledgeable about the systems who can serve as witnesses Legal Requirements - Conclusions * Other Considerations Obsolescence: Aside from the storage medium, consider whether the format of the electronic document (e.g., .pdf) will be accessible long-term Content: Be conscious of how the system treats embedded/hyperlinked materials when a page is signed or document closed for storage “Hybrid” systems: If “wet” signed printouts of an ELN are used, consider serial numbers or other method to replicate the “bound” and “continuous” characteristic of traditional lab notebooks * Questions? Thank You John L. Gase (312) 616-5644 jgase@ Seattle1420 Fifth Avenue Suite 3670 Seattle, Washington 98101-4011Tel: (206) 428-3100Fax: (312) 616-5700Washington, D.C.700 Thirteenth Street N.W.Suite 300Washington, D.C. 20005-3960Tel: (202) 737-6770Fax: (202) 737-6776 ChicagoTwo Prudential Plaza, Suite 4900180 North Stetson AvenueChicago, Illinois 60601-6731Tel: (312) 616-5600Fax: (312) 616-5700Rockford6815 Weaver RoadSuite 300Rockford, Illinois 61114-8018Tel: (815) 963-7661Fax: (815) 963-7664 Electronic Laboratory Notebooks: Requirements, Selection Best Practices John Gase Leydig, Voit Mayer, Ltd. Scope of the Pre