Article Summary

Signed, Sealed and Indelible

Nicoe Vaughan-Spickers. Health Management Technology. Altlanta: Mar 2007. Vol. 28, Iss. 3; pg. 22, 3pgs

This article talks about a pharmaceutical company called Ferring Pharmaceuticals which identifies and develops products in the fields of urology, gynecology, fertility, gastroenterology, and endocrinology. It discusses how this company decided in 2004 to change from paper lab notebooks to an Electronic Lab Notebook (ELN). Lab notebooks are essential for creating what is called a " trail of evidence" that protects valuable intellectual property when new products are being developed by R&D groups in the life-science industry as well as other science-based industries. The information contained can contain the record on when a new invention was conceived as reduced to practice. This information is essential for patent protection and patent infringement cases.

The article begins by talking about how important it is in the healthcare, biotechnology, and pharmaceutical industries to bring new products to market more quickly. It greatly increases the opportunity for revenue and company growth. In order to do this these types of companies must constantly look for ways to streamline processes to allow research scientists to spend more time actually producing work and less time documenting their work. In doing this it is important to make sure that these processes continue to adhere to strict quality standards as many products made in these industries are regulated by governmental agencies like the FDA.

The article goes onto discuss how most companies in health care and pharmaceutical industries still rely on paper lab notebooks to protect intellectual property even though there are electronic software versions available. There are problems with paper lab notebooks which include illegible, incomplete or error filled notebooks that can make it impossible to repeat a key experiment. Also, often it can be extremely time consuming to find the right lab notebook since there can be dozens in a single lab. The reason companies have been hesitant to adopt an electronic version despite these issues is a perception that Intellectual Property protection can not be managed by electronic systems, in order to have this protection you need a signature and witness that can only be obtained by using a paper lab notebook.

Ferring Pharmaceuticals took the risk and switched to an ELN with very positive results. They believed by doing this that they would provide a way speed up information retrieval, make it easier to collaborate and share knowledge among its 100 scientists and different sites, and also to speed up documentation and data entry process. The company chose to use a digital time-stamp technology embedded in its Electronic Lab Notebooks so that the notebooks would be able to still be used for Intellectual Property protection. The software was called Surety's AbsoluteProof technology and it allowed for a unique timestamp token or seal to be generated for every electronic document produced in Ferring's ELN's. The timestamp or token was stored off site in a data center that was fully accessible, searchable and verifiable.

The system was easily implemented with a half-day specialized training for scientists. Scientists also had two week time frame to experiment with and test the ELN system before it was implemented. The user acceptance was high and the system has increased the efficiency of scientists by saving countless hours by getting rid of the manual process of documenting experiments in lab notebooks and having them signed and witnessed.

This article relates back to chapter 13 because it illustrates how a successful information system was designed and implemented. It also illustrates how important getting the end user involved is through training and input so that they will accept the new system once it is implemented. Also, it shows how a whole organization can change with the design and implementation of a new system. Ferring got rid of a completely outdated system and successfully implemented a new system that is still not widely accepted by the rest of the industry.