In January we hosted a webinar that explored the ways that DocuSign is being used by Life Science companies to implement a successful digital strategy. And as those in the industry know – whether you’re launching medicines to treat Type 2 Diabetes or improving diagnostics – any life science company looking to go 100% digital needs to comply with 21 CFR Part 11 for regulated workflows and processes.
Our recent discussion highlighted how DocuSign’s Part 11 Module can be used for regulated business use cases for biotechs, pharmaceuticals, CROs, and medical device companies.
Below are the five key takeways from the conversation.
- A majority of attendees felt their companies were only halfway through their journey towards a 100% digital business.
Companies have invested millions to go digital in the life sciences industry, but we still print, sign and overnight documents. As IT and Business leaders, we need to advocate for digital strategies and lead change management processes to shift that paradigm. Our millennial workforce expects to use mobile devices for all their business transactions. Mobile and digital technology needs to be readily available or we will become extinct.
- Getting the compliance department on board to use electronic Part 11 signatures is a significant adoption challenge in most organizations.
Adopting digital technology for Part 11 regulated use cases falls under close regulatory scrutiny from the FDA. So despite the clear benefits of digital investment – accelerated time to market, reduced development costs, and improved process visibility – compliance business owners are often risk averse and not ready to embrace digital. Involving the compliance team from Day 0 is critical to the the success of any digital strategy.
- Education is needed to drive adoption of digital technologies in the cloud – particularly when it comes to retention and validation.
One of the most common questions we receive is whether we keep customers’ documents. Why is this so important? Because retention policies stipulated by the Part 11 regulation guide organizations to purge documents and keep them on their own systems, behind the company firewall. We recognize this is a common customer requirement in regulated businesses and you have the option to purge documents from DocuSign and file them on your own internal systems.
- You won’t be the first one to implement Part 11 eSignatures with a SAAS solution.
Several of the top 50 global pharmaceutical and medical device companies have adopted DocuSign’s Part 11 Module for regulated workflows and processes, and industry partners are hard at work building integrations to further enable our customers to run a fully digital business in clinical operations, quality, manufacturing and beyond. Our MOMENTUM user conference and life science webinar series feature many of these stories from AstraZeneca, ACIST Medical and more.
- We offer adoption best practices for deploying Part 11 electronic signatures for your regulated use cases.
First things first, get started on your digital strategy. And you’ll have an easier time mobilizing resources with senior level support. Beyond those basics, ensure that compliance, IT and business leaders are collaborating to identify high priority projects and use cases to pilot digital technology and get feedback from users. Setting up a Center of Excellence is a great way to have centralized support for provisioning new users, scaling digital initiatives efficiently across your organization, and documenting time and cost savings to build momentum.
Hungry for more? Tune into our on-demand webinar from January 20.
Looking for more reasons to go digital and get tips to jump start your success? Check out the following posts on why digital is at the forefront of pharma initiatives in 2016 and the 3 C’s of successful adoption for medical device manufacturers – and really all life science organizations.