It’s easy for you to evaluate iExperiment through Amazon Web Services. A three-part tutorial is available, under the Free Trial tab in the navigation bar above, to guide you through i) the creation of an Amazon Elastic Compute Cloud instance using the iExperiment AMI, ii) configuration of iExperiment, and iii) adding your first researcher.

Completed PDF Records Implemented in iExperiment

iExperiment is now capable of generating an Adobe PDF document upon the completion of an experiment record. On the first page of the PDF record there is a signature area where both the author of the record and a witness can sign; see figure below. This is suitable for digital signatures, but may not be appropriate if you are still using hand-written signatures. Fortunately, the PDF creation process can be modified to meet these needs.

Figure: Top of a Completed PDF Record

The top of a completed PDF record prepared by iExperiment, Colabrativ’s enterprise electronic notebook. The record has been signed by the author, but has not been witnessed yet.

The creation of the completed record PDF is controlled by an EXtensible Stylesheet Language transformation (XSLT) file that can be modifed to meet the specific needs of the research organization. It is possible to change the XSLT file on the iExperiment server to:

• Add or remove signature lines.
• Change the styling for the record, including the font and font size.
• Add a watermark.
• If the signatures need to be placed on each page, the footer could be changed to contain the signature lines.

Browser Compatibility of iExperiment

iExperiment is built on Google Web Toolkit and is not compatible with all browsers. Currently, iExperiment works with Mozilla’s FireFox and Google’s Chrome, but does not work with Microsoft’s Internet Explorer or Apple’s Safari. Both Safari and Internet Explorer suffer from the same two problems:

1. The text editor fails to maintain preexisting text.
2. The file drag-and-drop capability introduces characters into the file names in Safari, and does not work at all in Internet Explorer.

The SAFE-BioPharma Association is a non-profit association formed by a group of pharmaceutical companies, including AstraZeneca, Pfizer and Johnson&Johnson, to establish a digital signature standard (SAFE-BioPharma digital signature) for the biopharmaceutical industry that would be accepted by federal agencies, such as the Food and Drug Administration. The driving force behind the need for digital signatures is cost and time savings that digital records enable. The acronym SAFE stands for Signatures and Authentication For Everyone.

Selection of SAFE-BioPharma Digital Signatures

Colabrativ, Inc. selected SAFE-BioPharma™ Digital Signatures for the following reasons.

• SAFE-BioPharma digital signatures are accepted by all of United States federal agencies (see SAFE-BioPharma is Cross Certified with Federal Bridge Certificate Authority), regulatory agencies in 27 European Union countries, and a majority of the pharmaceutical industry companies that utilize digital signatures. They are 21 CFR Part 11 compliant.
• SAFE-BioPharma offers both hardware and software based digital certificates. We were particularly interested in a digital certificate that an individual has control of, i.e. a digital certificate token (Aladdin eToken). Many digital signature options are signature services, where an individual’s certificate is accessed through the internet.
• There are three ways of identity proofing: online, use of a Notary, and Trusted Agent model identity proofing. We used both the online and a notary to establish the identities of our staff and a service provider. We felt that it was important to have an independent person establish an individual’s identity, and therefore we did not establish a SAFE-BioPharma Trusted Agent within Colabrativ, Inc.
• The SAFE-BioPharma™ Association has a large collection of information on digital signatures, and their use in their Info Center. In addition, members have access to the SAFE Implementation Toolkit that contains documents supporting the implementation of SAFE digital signatures.
• Cost ‐ We found that SAFE-BioPharma membership was one of the least expensive digital signature options. The cost of a SAFE-BioPharma membership is as little as $50 per user per year. Membership has a five person, three year minimum.
• The SAFE-BioPharma digital identity service is managed by Verizon Communications Inc.

Documents with Both Digital and Non-digital Signatures

There are a lot of organizations that we deal with that are not accustomed to digital signatures, and do not understand how they work. A digital signature is a wrapper around a document that both ensures that the document has not been changed since it was signed, and identifies the individual that signed the document in a verifiable way. I actually like Surety’s modern-day wax seal analogy. A nobleman’s wax seal both identified the sender of the letter and ensured that the envelope containing the letter had not been open or tampered with.

If you are an organization that does not have digital signatures for your staff, and are working with an organization that does, then you should observe the following procedure when jointly signing a document:

1. Printout the signature page and sign it.
   You may need to find an acceptable solution to a situation in which you do not want to sign the document before the other party has signed it. If you require this of an organization that would like a digitally signed document, you are doing them a disservice, because once you print out and scan the signature page, the digital signature can no longer be validated.
2. Compile the body of the document and scanned signature page into an electronic version.
   We use Adobe Acrobat X Pro to insert the scanned signature into a PDF document. We typically create a Microsoft Word version of the document without the signature page, open it with Acrobat, and then use the Tools – Pages – More Insert Options – Insert from Clipboard function in Acrobat to add the scanned signature page to the bottom of the document.
3. Send the document to the other party for their digital signature.

What you will get back is a document that has the benefits of a digital signature. It cannot be changed without invalidating the digital signature. If it has a SAFE-BioPharma digital signature on it, you will know that it is accepted by all of the federal agencies.

Digital Signatures Display

One final note – digital signatures are large (see below). They are difficult to read if they are squeezed into a typically signature box. This is not really an issue, since most programs that recognize and validate digital signatures allow you to examine the signature information. If for nothing else but esthetics, it is worth considering enlarging the signature area for a document that will be digitally signed.

Example of a Digital Signature

SAFE-BioPharma™ is a trademark of the SAFE-BioPharma Association.