Digital Signature Software for Life Sciences

Go Paperless without the Compliance Risk.

Replace slow, manual signing with a digital workflow designed for Medical Device and Life Science innovators. Secured Signing delivers seamless 21 CFR Part 11 compliance to keep your business moving fast.

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Get all your Life Sciences & Medical Devices documents signed easily

Using advanced features that make your life easy

FDCA

How Secured Signing Meets FDA CFR 21 Part 11

Why Life Sciences & Medical businesses around the world use Secured Signing

Legal Compliance

We’re FDA 21CFR Part 11 compliant (click here to find out more) and meet regional requirements like HIPAA, eIDAS and EMA.

We're Paper Free

We don’t need paper – saving the environment and the clutter on your desk & in storage areas.

Better Identification

We improve signee identification and verification of signed documents – you’ll never have to question the identity of a signer.

Improved Processes

We speed up slow offline processes – no more project delays due to missing paperwork or time spent chasing signatures.

Increased User Experience

We improve user experience – with just a few clicks on any device documents can be signed and automatically emailed back. 

Improved Document Security

We ensure document security – minimizing the chance of data theft or forgery with our user based PKI Digital Signature.

Internal Compliance

We increase compliance by ensuring paperwork is signed properly the first time, never gets lost and gets stored in the right place.

Check what one of our Science & Medical clients had to say!

Reduced Time and Frustration for All Concerned

We issue the links and people get back to us overnight or even within the hour. We just set the deadline for each candidate, and the system takes care of the reminders for us. This invaluable feature has reduced time and frustration for all concerned. 

Secured Signing was very fast and responsive whenever we asked for something. Their customer service is amazing.

Kym Volp, Evolve Scientific Recruitment

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.