Wet signatures cost the pharma industry more than you think

Wet signatures, where a mark is made with a pen on a piece of paper, have long been the gold standard for providing an irrefutable mark of intent, identity and for agreement. For centuries, ink has held sway over legal and other important documents, with a scribble on a piece of paper proving any number of things. And that’s part of the problem. In the modern era, despite the much-publicised shift to digital, the pharmaceutical industry still places a premium on signed paper documents. Appropriately implemented, trusted or electronic signatures could swiftly remove the problems associated with keeping paper records – storage, degradation, loss, proof that the signature is real; the list goes on.

In heavily regulated sectors such as pharmaceutical, the potential benefits of e-signatures are clear, including an increased sense of credibility, greater information security, speed, and a better service experience. A busy hospital or health service provider can use e-signatures to speed up processes, from drug and equipment supplies to regulatory compliance, patient consent and staff contracts. Digital audit trails can record a document’s date, location and timestamp, as well as ensure actions that cannot be modified.

Figures suggest e-signatures can save the average pharmaceutical company more than 600 hours a year. So why are wet signatures still used so often?

The technology exists to have a complete digital transformation, yet the entire industry is still drowning in paperwork. The healthcare industry is heavily regulated for very good reasons. This means that practically everything must be fully documented, even down to the smallest medical aid such as a mask or syringe. Reams of paperwork are associated with each item. that might include who designed it to what specification, what material batch it was made from, who inspected and assembled it and so on. Each item also has a paper trail, complete with ink scribbles that are often illegible. These follow the item’s journey through the supply chain. And we all know how easy it is for the paper to go missing, get damaged or be filed in such a safe place that it is practically irretrievable several years later.

All this continues because of the trust given to wet signatures. But what is that and why do they remain so prevalent?

A scribble of ink on a piece of paper is meant to simultaneously represent the identity of the signer, a stamp of authenticity, and an irrefutable mark of intent. When of vital legal importance, a notary may be involved to witness the signature and to attest to the identity of the signer. But even then, the signature is only as trustworthy as the notary, assuming they correctly performed an identity verification and established authority to sign.

What about the majority of wet signatures in the pharmaceutical supply chain that are not witnessed by a notary? Can an illegible pen mark on paper really be relied upon by others, particularly several years later when people have moved on? Can it be proved or even known that the signature really captures identity, intent and authenticity? Is it authoritative?

The move to digital should not just be about replacing paper processes with virtual paperwork. Even though the reduction of paper achieved by digitising is good for the environment, it also has enormous opportunities for driving efficiency and improving the trust that can be placed in the information and its provenance.

Digital technologies exist that can capture and notarise evidence in a far better way. These solutions have the potential to:

• Capture the digital identity of the authorised signer
• Capture the digital identity of the authenticated witness
• Permanently timestamp the event
• Permanently attach rich evidence such as files, images, videos and screenshots
• Provide an irrefutable, indelible record that is instantly shareable
• Readily integrate into multi-party automated workflows
• Link the physical to digital with RFID or QR codes

For the pharmaceutical sector fully adopting e-signatures means they could choose the right tools for them to track items throughout the supply chain, automatically storing necessary evidence and immediately sending it to those who need to know, both within the organisation and beyond its boundaries.

Manufacturing data, quality inspections, regulatory compliance, material details, parts locations and shipping details, for example, could all be added to a continuously verifiable, complete and reportable history of each and every asset.

Imagine how much faster, more efficient and safer the pharmaceutical industry and the wider healthcare sector could be if those who need to know can instantly find out who did what and when? And importantly can verify and trust the information that is delivered.

Framed in the light of the ever-rising strain on global healthcare providers – especially on nationalised systems like the NHS – and the cost savings offered by simple provision of e-signatures become a no-brainer.

Last year’s UK government-commissioned Goldacre Review of health data made 185 recommendations, including a call for increased transparency and adoption of modern open working methods – which could be bolstered and secured by increased use of e-signatures.

Importantly digital signatures now stand up in a court of law. E-signatures have been legally recognised and binding in the US since 2000, while the EU agreed to recognise the validity of an e-signature in 2016.

A digital signature, with all its associated data, is easily a stronger, more valid proof point than a wet signature. As RKVST CTO, Jon Geater, said when quoted on the legality of e-signatures by the BBC around the time the new EU law was added to the stature books: “A [written] signature is simply weak evidence that somebody agreed to do something. It is not exactly unique or special, nor does it prove particularly well that a person was genuinely present or consenting.”

Analysis from Capgemini in 2017 revealed that companies using electronic systems and digital solutions are 26% more profitable than those that don’t. This figure has undoubtedly been superseded today.

Meanwhile, the tools and technology to replace slow, manual and often faulty signature processes only continue to improve. Beyond the sometimes painful and expensive basic digital signatures of the 2010s we now have initiatives such as the Internet Engineering Task Force (IETF) Supply Chain Integrity, Transparency and Trust (SCITT) working group to easily add digital provenance information to data, and instant verification of data authenticity in one click or less.

Pen and ink cost the pharmaceutical and other regulated industries more than you think. So, if a high integrity electronic process is good enough to stand up in a court of law, isn’t it time we hung wet signatures out to dry?