By Daniel R. Matlis
Let’s face it; our industry is paranoid about sharing information. I often hear of the concern for disclosure of Intellectual Property, legal issues or trade secrets as justification for this behavior.
Of course our industry has a legitimate need to guard Intellectual Property, competitive data and trade secrets. If your notebook contained the compound that would cure for the common cold, you wouldn’t want your competitors to get their hands on it.
So why would Pfizer share their approach to securing the contents of their e-notebooks?
According to George Rathbun, Pfizer’s Director of Regulatory Compliance and a member of the Board of Directors of SAFE-BioPharma Association: “Pfizer developed this white paper to share with the rest of the industry our experience introducing electronic laboratory notebooks and SAFE digital signature technology. This is consistent with Pfizer’s role as a leader in the development of the SAFE technology within the pharmaceutical industry.”
If you have ever been in a Life-Sciences R&D Lab, you have seen the traditional laboratory notebooks. They are numbered, paper-bound books used to document daily experiments and activities conducted by researchers. It is imperative that the books be dated, signed and witnessed on a daily basis. Once full, the paper notebooks are submitted to a Records Management organization for archiving. These steps are critical since information contained in these laboratory notebooks are often used to prosecute product patents.
The transition to electronic lab notebooks (eLN) has been a dream for many years. The benefits of eLN are clear, a reduction of paper, savings in records management, easier access to stored information, and generally, less record-keeping time for scientists.
One key challenge to the adoption of eLN has been the implementation of legally binding electronic technology to sign and witness the content of the eLN. To address this issue, Pfizer relied on the use of the SAFE digital signature, an industry driven standard that allows scientists to apply an easy to use time-stamped electronic signature. The SAFE digital signature addresses the following issues:
1) Provides for the legally equivalent to a “wet” or ink-based signature
2) Meets regulatory guidelines such as 21 CFR Part 11 and HIPPA in the USA, as well as their international counterparts
3) Ensures security and data integrity
4) As a standard, it is designed to support global use.
The newly published Pfizer white paper entitled “Pfizer Implementation of SAFE Digital Signatures for Electronic Lab Notebooks,” chronicles the introduction, development and adaptation of digitally signed electronic Lab Notebooks. The system has more than 2200 users within Pfizer and averages more than 1000 signatures per day.
Some in our industry might still be scratching their heads about Pfizer’s openness on this topic. I say Kudos to Pfizer for sharing their successful implementation of digitally signed electronic Lab Notebooks. As you know, I’m a big believer in learning from success.
To learn more about Pfizer’s implementation of eLN, I highly recommend reading the complete whitepaper. The Document can be can be downloaded from the SAFE-BioPharma Association’s website.