Learn the hidden cost of paper-based processes and wet signatures
Emerging life sciences companies need fast, efficient, and scalable processes to speed their time from R&D to commercialization. Starting with a cloud-first digital approach can prove to be a competitive advantage in the early phases of your company. At this stage of your journey, the critical goal for your company is to accelerate clinical studies to commercialize and grow while remaining agile and efficient. Often, startups lack the life sciences expertise and resources to be sure what cloud-based systems are needed first and best suited for your unique business needs. We can help you select the right vendor for your emerging life sciences company.
Manual paper-based processes are still widely used in many regulated organizations, often delaying product launches and increasing development and operational costs. Electronic document signing and cloud-based storage tend to be an afterthought, given all the other priorities in building a new company. Add in the complexity of meeting the U.S. Food and Drug Administration (FDA) regulatory requirements, and moving your paper-based processes to the cloud becomes a bigger challenge.
Early on, it is understandable that your company is hesitant to make significant technology investments because of budget constraints. Many companies believe it is more cost-effective to use paper processes and wet signatures for document signing. However, they fail to understand the long-term cost of a wet signature. The industry-known cost is that the average price of a wet signature is $50 per signee per document compared to eSignature. With the tremendous number of documents that need to be signed, and each document requiring an average of 3-4 signees, the costs can begin to add up very quickly. With the heavily regulated life sciences industry, documents often need to be updated and resigned every few months, leading to paper-based bottlenecks within your organization.
With globalization and remote work onset, a single document can require signatures from parties in different parts of the world. From a business continuity perspective, this can raise many challenges. By taking a digital-first approach, your emerging company can drive better R&D and clinical research and make it easier for your partners, sponsors, and research organizations to quickly view and sign documents electronically. eSignatures provide a more simplistic way to ensure you have a Quality Culture from the beginning and reduce the overhead and burden of paper. It also brings in and allows you to retain higher quality talent, that in the year 2022, expects electronic systems versus paper-based processes.
USDM has delivered hundreds of 21 CFR Part 11-compliant validation implementations for DocuSign and Adobe Acrobat Sign. Through our Cloud Assurance subscription, we also have capabilities to maintain the ongoing release management for any eSignature system, so you don’t have to worry about keeping your compliant state. Besides being able to focus on other business priorities, the benefits of offloading your eSignature system validation to USDM include:
- Complying with global regulations such as the California Consumer Privacy Act (U.S.), HIPAA (U.S.), Annex 11 (EU), GDPR (EU), ERES (Japan), and ISO 27001:2013
- Importing documents and data with pre-built integrations and GxP, regulated capabilities based on decades of best practices
- Authenticating patients, investigators, and employees around the world to speed your time to market
- Significantly reducing your regulated implementation and validation time
- Harmonizing your GxP standard operating procedures and processes (we can write your SOPs too)
- Maintain continuous cloud compliance, so you don’t have to worry about new releases
We can move fast! Read this case study to learn how we have perfected our DocuSign implementation to get you up and running in as fast as 7 days!
If you need more guidance on what IT systems to deploy at what phase of your commercialization journey, this webinar has some practical guidance – IT Systems for Emerging Life Sciences.