Digital Signatures for Life Sciences: Digital Transformation in Support of Regulatory Compliance
How Adobe Sign helps life sciences companies maintain data integrity and comply with regulatory requirements.
by John Jolliffe
posted on 02-20-2019
Nearly every industry is in the process of “going digital,” searching for new ways to use technology to drive competitive advantage, operational efficiency, and enhanced customer experience.
But for life sciences companies, the competitive demands of digital transformation are made even more complex by some unique legal and regulatory requirements that fundamentally impact the way they create and manage both content and data.
Evidence suggests that companies are not always rising to the challenge, with around 30 percent of clinical trials being rejected by the FDA because of data integrity-related violations of Guidelines for Current Good Manufacturing Practice (CGMP). Common violations include forms that are incorrectly signed by the wrong individual, missing signature logs, forging of signatures or related documents, or use of pre-signed source documents.
Balancing clinical excellence with data integrity has emerged as a key strategic challenge for the industry. Whether managing clinical trials, gathering patient informed consent, or controlling good manufacturing practices, organizations require highly reliable, flexible, and trustworthy solutions if they are to successfully modernize business processes while complying with relevant regulations.
While compliance is frequently the driver, many companies are finding that the right digital signature solution can have many additional benefits, including a significant reduction in the cost of clinical development, shorter study timelines, better user experience, and higher data quality.
That’s why Adobe Sign and Trans Sped have worked together to ensure that Adobe Sign now works seamlessly with the unique trusted certificate infrastructure of Trans Sped, one of the most experienced digital certificate providers in the pharma and life sciences ecosystem.
As a result, life science companies can now flexibly deploy electronic and digital signatures (which includes both advanced and qualified electronic signatures in EU parlance) across desktop, mobile, and web devices, using both traditional and new cloud-based trust frameworks for online identity and trusted digital signatures. And it’s all in a way that enables them to comply with the most stringent e-signature laws and regulations, including the EU’s eIDAS Regulation, SAFE-BioPharma requirements, and FDA 21 CFR Part 11.
We think it’s an important contribution for a critical sector. Together, Adobe and Trans Sped are helping companies implement the International Council for Harmonisation (ICH) requirements for data and documents laid out in the E6(R2) Guidelines for Good Clinical Practice.
To learn more, you can download our White Paper E6(R2): Good Clinical Practice.
Topics: Industry, Digital Transformation, Healthcare
Products: Sign, Acrobat, Document Cloud