Summary
Emerging life sciences companies that cling to paper-based processes and wet signatures carry hidden costs that slow product launches and drain budgets. A cloud-first, digital signature approach accelerates R&D and clinical studies, simplifies global signing, and embeds a Quality Culture from day one. Done right, eSignatures are validated for 21 CFR Part 11 and kept compliant over time so your team can focus on getting to market.
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.
The true cost of a wet signature
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.
The hidden math: The industry-known cost of a wet signature is about $50 per signee per document. With 3-4 signees per document and documents that must be updated and resigned every few months, paper-based signing quietly compounds into a real drag on cost, speed, and quality.
Why digital-first wins for emerging companies
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.
eSignatures provide a more simplistic way to ensure you have a Quality Culture from the beginning and reduce the overhead and burden of paper.
Electronic signatures also strengthen the integrity of your records. Trustworthy, attributable, and tamper-evident signing supports the data integrity expectations regulators apply across GxP records, and a validated system makes those controls repeatable rather than manual.
How USDM validates and maintains your eSignature system
USDM has delivered hundreds of 21 CFR Part 11-compliant validation implementations for DocuSign and Adobe Acrobat Sign. Our risk-based approach aligns with modern Computer Software Assurance (CSA) thinking, focusing testing effort where patient safety and product quality risk is highest. 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
A digital-first eSignature path for startups
- Select the right vendor. Match a cloud eSignature platform to your unique GxP and business needs before you scale.
- Validate for compliance. Implement a 21 CFR Part 11-compliant, risk-based validation aligned to CSA principles.
- Harmonize your processes. Stand up GxP SOPs and global regulatory controls so signing is consistent everywhere.
- Maintain continuously. Keep the system in a compliant state through ongoing release management as the platform updates.
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. To keep validated systems audit-ready as they evolve, see our perspective on validation lifecycle management.
FAQ: Electronic signatures for emerging life sciences companies
Why are wet signatures so costly for a startup life sciences company?
The industry-known cost of a wet signature is about $50 per signee per document. Because each document often needs 3-4 signees and documents must be updated and resigned every few months, paper-based signing creates bottlenecks and steadily increases development and operational costs.
Do electronic signatures need to be 21 CFR Part 11 compliant?
For regulated life sciences records, yes. USDM has delivered hundreds of 21 CFR Part 11-compliant validation implementations for DocuSign and Adobe Acrobat Sign so your electronic signatures are trustworthy and defensible.
How fast can an eSignature system be implemented?
USDM has perfected its DocuSign implementation to get companies up and running in as fast as 7 days, helping emerging companies move quickly without sacrificing compliance.
How do I keep my eSignature system compliant after go-live?
Through the USDM Cloud Assurance subscription, USDM provides ongoing release management for any eSignature system, maintaining continuous cloud compliance so you do not have to worry about new platform releases.
What if I am not sure which systems to deploy first?
USDM can help you select the right vendor for your unique business needs and advise on what IT systems to deploy at each phase of your commercialization journey, from R&D to commercialization.
Ready to move off paper?
Take a digital-first approach to signing, validation, and ongoing compliance so your team can focus on getting to market. Contact us today to discuss a 21 CFR Part 11-compliant eSignature implementation for your emerging life sciences company, or download our Emerging datasheet to learn more.