AbbVie sets the stage for digital transformation with enterprise e-signatures on a global scale.

AbbVie is working to automate processes setting the stage for digital transformation with Adobe Acrobat Sign for enterprise e-signatures on a global scale.

Image source: Adobe Stock / Maksim Šmeljov.

Lori Crane is a problem solver, and had a revelation that, “there had to be a better way.” As senior manager of research & development (R&D) quality assurance (QA) within the Quality Systems group at AbbVie, she makes sure R&D documentation is compliant with global regulations and policies — and she’s always looking for ways to improve processes. As she says, “Anytime I can work smarter and make life easier for people, I’m all about that.”

For the past few years, Crane has been leading the charge to help AbbVie go paperless — an initiative with important strategic value for the global, research-based pharmaceutical company. AbbVie’s strategy is to deliver innovative medicines and to make a remarkable impact on people’s lives. To increase agility and free employees to focus on more complex work, the company is working to automate certain processes. Transitioning away from pen and paper is a crucial first step.

“AbbVie manages a lot of documents, from research and development to manufacturing processes to HR, purchasing, and legal,” says Crane. “Collecting multiple signatures through email and on paper takes time and administrative work, and we knew there had to be a better way to do it.”

A global solution for e-signatures would not only save time but provide an entry point into automation. Going paperless is also an important way AbbVie is furthering its sustainability initiatives.

The project team tackles compliance

One of the biggest hurdles Crane and her team had to overcome was regulatory compliance, particularly related to the Food and Drug Administration’s Title 21 CFR Part 11 and Good Documentation Practices (GDP). When it comes to clinical trials and manufacturing, these regulations help ensure that AbbVie and other pharmaceutical companies follow strict protocols for patient safety. E-signed documents need to be accurate, legible, and permanent — and facilitated through a qualified signing tool.

Getting the technology right and building out the compliance capabilities was a key piece of the initiative. Designing their solution around Adobe Acrobat Sign, Crane and her team focused on ensuring that heavily regulated documentation processes were highly secure and validated, with two-factor authentication, audit trail reporting, and support for proper storage and archiving. The next step was to roll out the technology to the entire company — a big lift for a small team. But with well-established governance, a solid support model worldwide, and champions across AbbVie to help promote the initiative, the team went live less than a year after kick-off - and things haven’t stopped moving ever since.

Rapid adoption during a pandemic

With an enterprise e-signature solution in place, Crane and her team launched two global campaigns — meeting virtually with people in R&D, operations, and commercial divisions across 30 countries.

When the COVID-19 pandemic hit and much of the workforce began working remotely, the e-signature option gained rapid adoption. The project team started onboarding a mind-boggling 2,000 new users every week. “In just over a year, we expanded our user base from 8,000 employees to 35,000,” says Crane. “The volume of e-signature transactions has grown 330 percent.”

With a completely digital signing process, two-factor authentication, and a clear audit trail, AbbVie always has a record of who signed and when. That reduces risk and eliminates rework associated with getting a clean signature. The solution keeps documents safe as they get processed, signed, and stored.

For all users, it’s an easier, more intuitive experience, consistent across AbbVie. Instead of getting an attachment through email, they simply click on a link and are guided through the signing process — even on a mobile device. That streamlines the process, delivering estimated time savings of 75 percent per document based on time trials run by Crane’s team.

Looking ahead to further integration

Crane and her team are not finished yet. They continue to evangelize the e-signature solution, providing global support and training to their colleagues in 70+ countries. And they are working with the AbbVie business technology team to integrate the solution with other internal systems and business applications.

“Integrations will help us broaden the use of e-signatures across AbbVie and give us more flexibility to automate processes,” says Crane.

It’s an exciting path forward — one that she and her project team are helping to pave.