Where Next for the Digital Age?

I found the BBC News story today regarding digitisation of the UK Courts system very interesting. The Government has plans to make courtrooms in England and Wales “fully digital” by the year 2016, ending what it described as “an outdated reliance on paper”. In addition to initiatives such as secure Wi-Fi in courts and the routine taking of evidence by video-link, the plans include getting “rid of our outdated paper-based system”.

This story just hit home once again to me the slow pace within the pharmaceutical and biotechnology industry of the adoption of digital technologies that facilitate a paperless environment. We’ve recently had the European Medicines Agency (EMA) issue a reflection paper on the management of clinical trial documents (the TMF) and they’re still urging caution on any reliance on digital records! At the same time we see the legal profession itself absolutely comfortable with a digital environment….. electronic signatures and all! And as we look at other sectors of industry – from banking and finance through to retail – they have mostly been using technologies that support a paperless office for many years.

This is the 21st century; a time when we have International Standards for digital certificates and European Directives for Electronic Communications and for Electronic Signatures. So isn’t it about time we broke down the final barriers to working digitally? Next time you create a document that has a wet-ink signature line, just ask yourself “Is there a technology out there that can enable me to capture that signature digitally and still remain compliant with the pertinent regulations?”. I’m willing to bet that 99% of the time, the answer will be a resounding “Yes”.


About rammellel

Records management consultant to the life sciences / pharmaceutical industry
This entry was posted in e-records, Litigation, Records management practice, Technology. Bookmark the permalink.

2 Responses to Where Next for the Digital Age?

  1. The use of digital signatures in the document are not legally binding.Signatures are not authenticated and also not verified according to process.But it needs to be legally binding to stop fake signatures counter.

    • rammellel says:

      I’m not sure I fully understand the comment made here…. although it appears to have come from somebody who promotes WordPress E-Signatures! This really only serves to demonstrate the lack of understanding and sheer misunderstanding about digital signatures. The assertion is made that “digital signatures in the document are not legally binding”. However, I can categorically state that a properly implemented digital signature is as legally binding – if not more so – than a traditional wet-ink signature. This is especially so if using a qualified digital certificate, as described in the European Directive on Electronic Communications and Electronic Signatures. The author then goes on to say “Signatures are not authenticated”. Again, this is a common misunderstanding. A qualified digital certificate has been authenticated by the Certifying Authority. It is no less authenticated than a wet-ink signature; in fact, other than a notarized signature, a wet-ink signature is often NOT authenticated. The issue is that many digital signature solutions (such as the WordPress e-Sign Plug-in) do not include a process for signer authentication and do not use qualified digital certificates belonging to the signer. Authentication relies upon trust of the email address only of the signer and a digital certificate is applied belonging to the software provider e.g. ApproveMe, DocuSign etc.

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