Digital Signature Platform for Life Sciences

Go Paperless. Stay Compliant.
Replace slow, paper-based signing with a digital workflow built for life sciences and medical device companies. Secured Signing is fully 21 CFR Part 11 compliant, so you move fast without compromising regulatory standards.

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Get all your Life Sciences & Medical Devices documents signed easily

Patient Contracts

Clinical Trial Onboarding

Sales & Service Agreements

Monitoring Reports

Label Change Documents

Vendor Contracts

Patient Consent Forms

Staff Onboarding

FDA 21 CFR Part 11 compliant

Secured Signing meets all requirements for electronic records and signatures under FDA 21 CFR Part 11. Download our compliance overview for the full technical details.

Why Leading Life Science Companies Trust Secured Signing

Regulatory compliance

Meets 21 CFR Part 11, HIPAA, eIDAS, and EMA requirements out of the box.

Stronger verification

Advanced signer identification eliminates doubt about who signed what and when.

Faster turnaround

No more project delays from missing paperwork or time spent chasing signatures.

Reduced document risk

PKI-based signatures protect against data theft, forgery, and unauthorised access.

Sign on any device

A few clicks from any device, signed documents are automatically returned by email.

Fully Paperless Workflow

Cut storage costs and environmental impact, no printing, no filing, no clutter.

Seamless Integrations

Easily send documents by integrating into all the tools you use everyday, including your proprietary company systems.

FAQ about Secured Signing and FDA 21 CFR Part 11

Is Secured Signing compliant with FDA 21 CFR Part 11?

Yes. Secured Signing is fully compliant with FDA 21 CFR Part 11, which governs electronic records and signatures in the life sciences industry. We have been independently audited for FDA 21 CFR Part 11 and successfully passed the audit process. We also meet other regional regulatory requirements including HIPA and eIDAS guidelines. 

Secured Signing supports a wide range of life sciences documents, including patient contracts and consent forms, clinical trial onboarding documents, sales and service agreements, vendor contracts, label change documents, monitoring reports, and staff onboarding paperwork. 

We use X.509 PKI (Public Key Infrastructure) digital signatures combined with optional SMS two-factor authentication and ID verification to confirm signer identity. Every signed document includes a full audit trail, so you can prove who signed, when, and from where. 

Yes. Documents are tamper-evident using user-based PKI digital signature encryption, which minimizes the risk of data theft or forgery. Secured Signing is also SOC 2 Type 2 certified, ISO 27001 certified, and has been externally audited for FDA 21 CFR Part 11, demonstrating our ongoing commitment to security, availability, and confidentiality. 

Yes. Secured Signing integrates with a wide range of third-party platforms and also offers a robust API, allowing you to connect directly with your proprietary company systems or existing software tools. 

Secured Signing automatically sends reminders and notifications to signers who haven’t completed their documents, reducing the need for manual follow-up and helping ensure nothing gets missed. 

Yes. Signers can complete documents on any devicedesktop, tablet, or mobilewith just a few clicks. The signed document is then automatically emailed back to the relevant parties. For in-person signing, Secured Signing has a face-to-face (F2F) option. 

Streamline Your Document Processes with Secured Signing's Digital Signatures

To see exactly how our digital signing solution works and to get a custom quote to turn your science or medical forms into digitally savvy ones simply fill out the form below and one of our team will be in touch.