In the life sciences industry, trust and compliance go hand in hand. Whether you’re a pharmaceutical company running clinical trials, a medical device manufacturer bringing new products to market, or a contract research organization (CRO) supporting regulated studies, your documentation processes must meet strict legal and regulatory standards.
One of those key regulations? 21 CFR Part 11, set by the U.S. Food and Drug Administration (FDA). It’s not just a checklist item; it’s a foundation for ensuring that digital records and electronic signatures are secure, traceable, and legally binding.
Meet SutiSign, an intelligent eSignature platform designed with compliance at its core. Built for organizations navigating complex regulatory environments, SutiSign helps companies across life sciences, healthcare, and biotech industries stay aligned with 21 CFR Part 11 requirements, without compromising on speed, usability, or scalability.
What is 21 CFR Part 11?
Put simply, 21 CFR Part 11 sets the FDA’s standards for using electronic records and electronic signatures in place of paper-based documents. Its goal isn’t to slow things down – it’s to ensure that when companies digitize their processes, they do so securely and transparently.
This regulation applies to any business that creates, modifies, maintains, archives, retrieves, transmits, or submits records under FDA-regulated activities. Think clinical trial agreements, manufacturing logs, quality control reports, or supplier contracts, all areas where digital transformation is happening fast, but compliance can’t be left behind.
Who Needs to Comply?
If your organization falls under any of these categories, chances are you’re already dealing with 21 CFR Part 11:
- Pharmaceutical companies
- Biotech firms
- Medical device manufacturers
- Contract research organizations (CROs)
- Clinical labs
- Cosmetics and food producers
Even if not every document you handle requires compliance, many of your critical workflows likely do. And the tools you use, especially online eSignature platforms, need to support this from day one.
What Does 21 CFR Part 11 Require From eSignature Platforms?
It’s more than just putting your name on a PDF. To be compliant, electronic signatures must meet specific criteria outlined in Subpart C of 21 CFR Part 11:
- Unique Identification: Each signature must be assigned to a single user and cannot be reused or reassigned.
- Identity Verification: Before allowing a signature, the system must confirm who the user is.
- Legal Equivalence: The eSignature must carry the same weight as a handwritten one.
- Signature Components: Non-biometric signatures must include at least two elements like a username and password.
- Audit-ready Trails: Every action must be logged with timestamps, reasons for signing, and printed names.
- Security Safeguards: Passwords must be protected, expird regularly, and systems must detect unauthorized access attempts.
How SutiSign Helps You Stay Compliant
SutiSign wasn’t built just to sign documents – it was built to secure them, track them, and prove their integrity when it matters most. Here’s how we align with 21 CFR Part 11:
Identity Verification & Unique Signatures:
Every user gets a unique ID. Before signing, identity checks are performed to ensure authenticity. No shared accounts. No impersonation. Just clear, auditable trails.
Signature Manifestation:
Each signature includes the signer’s full name, date, time, and reason for signing, all clearly displayed and permanently linked to the document.
Multi-Factor Authentication:
SutiSign supports strong authentication methods, including passwords, tokens, and other verification layers required under Part 11. This ensures only authorized users can sign sensitive documents.
Audit Trails & Logging:
From request creation to signing, every step is recorded. Timestamped logs show who accessed the document, what changes were made, and who signed, making audits stress-free.
Security Controls:
SutiSign includes robust transaction safeguards, automatic password expiration, and procedures for managing lost or compromised credentials. We also test devices and tokens regularly to ensure they haven’t been tampered with.
Integration With Regulated Workflows:
Whether it’s a clinical trial consent form, SOP approval, or a vendor agreement, the cloud-based eSignature platform integrates seamlessly into regulated business processes, helping you digitize without risking compliance.
Why Compliance Shouldn’t Slow You Down
A common misconception is that compliance slows down processes and adds unnecessary hurdles. In reality, when done right, it enhances efficiency, reduces risk, and builds trust across stakeholders.
With SutiSign, organizations don’t have to choose between speed and security. Our platform empowers teams to work faster while staying fully aligned with FDA guidelines.
Imagine being able to close supplier contracts remotely, approve SOP revisions in real-time, or collect patient consents digitally, all without worrying about regulatory missteps. That’s the power of a truly compliant smart eSignature software solution.
The Future of Secure Signing in Life Sciences
As remote work becomes the norm, global collaboration increases, and regulatory scrutiny tightens, having a trusted, compliant eSignature solution is vital to staying competitive and compliant.
SutiSign is designed to fully support 21 CFR Part 11 requirements, giving life science companies and their partners the confidence to move faster, reduce paper dependency, and maintain the highest standards of data integrity.
Whether you’re managing clinical documentation, supplier agreements, or internal approvals, SutiSign gives you the power to sign smarter.
Ready to simplify compliance while accelerating your digital workflows? Try SutiSign today and sign with confidence.
