Reference story Aeterna Zentaris

The pharmaceutical company signs quality assurance documents, technical agreements, quality agreements, and deviation or change notifications entirely digitally using d.velop sign – ensuring full audit and inspection compliance.

• Quality assurance with legally compliant digital signatures
• Signatures authenticate contracts and clinical studies
• Next step: digital archiving of documents

Signing Contracts and Documentation in the Pharmaceutical Industry with d.velop sign

Aeterna Zentaris GmbH enables legally compliant global signing with a scalable solution

Aeterna Zentaris GmbH is a biopharmaceutical company specialising in the development and commercialisation of pharmaceutical and diagnostic products in the field of endocrinology. Headquartered in Toronto, Canada, its flagship product is Macrilen® (known as Ghryvelin™ in Europe), an oral test for adult growth hormone deficiency (AGHD). The company collaborates with various international partners and conducts global clinical studies. Today, Aeterna Zentaris employs 22 people across Germany, Canada, and the USA.

Daily use of digital signatures in the pharmaceutical sector

The biopharmaceutical industry is highly regulated. Signatures are required daily on a wide range of documents, including licensing agreements, technical agreements, quality agreements, distribution contracts, and deviation or change notifications for audit and inspection purposes.

Legally compliant signatures in quality assurance

Previously, Aeterna Zentaris used a basic electronic signature (EES) solution from a well-known provider. However, as regulatory requirements increased, the company needed to switch to Qualified Electronic Signatures (QES). “The requirements for electronic signatures have grown, so it became necessary to switch to QES,” explains Mile Obradovic, Head of IT at Aeterna Zentaris.

Vendor research and transition to d.velop sign

The previous provider could not meet the updated requirements. “It became incredibly complicated – they offered huge packages with thousands of licences,” says Obradovic. “I think we were simply too small for them.” He began researching alternatives and reached out to d.velop. “I remembered d.velop from earlier document management projects, so I gave them a call.”

d.velop impresses from the very first contact

Mile Obradovic was convinced from the very first interaction with d.velop. “The consultation, the demonstration of d.velop sign in a Teams session – everything just clicked,” he says. “In my experience, a project with a partner is most successful when you communicate on equal footing. You understand each other, the portfolio fits. If the gap is too wide, it becomes incredibly difficult.”

d.velop sign as a perfectly tailored signature solution

This was exactly the case with d.velop. A proposal followed, Aeterna Zentaris gave the green light, and onboarding began. “I can honestly say only good things about the collaboration,” says Obradovic. Just a few weeks passed between the contract award and go-live. For the past two months, Aeterna Zentaris employees have been using d.velop sign intensively.

In-house training at Aeterna Zentaris

The switch from basic to qualified electronic signatures required little adjustment for staff. “The look and feel was slightly different, but they were already familiar with the process,” Obradovic recalls. He personally handled onboarding and basic training. “Some colleagues had minor issues with the identity verification process during onboarding – but that’s completely normal. I was happy to help.” “If anyone has questions now, they either ask me or visit the d.velop website, where there are plenty of helpful training materials like videos and guides. Everything is available there at any time.”

6 steps to the introduction of an electronic signature

In this webinar, you’ll learn how we can successfully introduce the electronic signature in the organisation using six steps – from understanding the benefits to getting started with d.velop sign.

Agenda

• Why should I introduce a digital signature?
• d.velop sign as e-signature of the d.velop platform
• 6 Steps to introducing an e-signature
• Next Steps: How we get started digitally together

Start with just one click.

Signatures authenticate contracts and clinical studies

For Aeterna Zentaris, the legal certainty provided by a Qualified Electronic Signature (QES) is of utmost importance. This is due not only to the highly sensitive and strictly regulated nature of the biopharmaceutical industry, but also to the international scope of its operations. Many regulatory authorities require transparent and traceable documentation. In addition, the company’s network of collaborations is complex – involving partners, companies, universities, and clinics. In this context, signatures are used to authenticate a wide range of documents, from contracts to documented progress and results of clinical studies.

Next project with d.velop already in the pipeline

Looking ahead, Mile Obradovic sees further potential for collaboration with d.velop: “We have another project coming up that isn’t directly related to digital signatures or contract management, but could still be implemented using d.velop’s portfolio.” The focus of this upcoming project is on digital document archiving – and once again, d.velop is a strong contender, thanks in no small part to the positive experience during the QES implementation at Aeterna Zentaris.