Introducing Donor Records

Make every FDA inspection a success

Give your team the tools it needs to hit your inspection goals with confidence.

Compliant

Donor Records is compliant with FDA 21 CFR 1271 and 21 CFR 11, and meets HIPAA compliance requirements.

Secure

Backed by enterprise-grade security, hourly backups, and 24/7 monitoring, your data is always safe.

Efficient

A friendly user interface with a mobile-first mentality ensures ease-of-use by both donors and administrators.

We provide smart and comprehensive FDA guidance

Compliance Concierge

Questions? Advice? Knowledge? Our experienced Compliance Concierge will prepare your team with the personalized guidance they need to confidently prepare for inspections.

Inspection checklists

We provide the tools you need to prepare for FDA inspections, including customizable quarterly checklists so your team is always on the same page.

We have you covered

Easily keep track of changes

With the ability to add notes on any change, a detailed timeline, and a donation Audit Trail, you can keep track of what the rest of your team has been working on so everybody's on the same page.

Notes

Add notes and comments to any change in the platform to keep everyone informed and working toward the same goals.

Audit Trail

View a detailed and easy-to-read Audit Trail so you know exactly what changes have been made and by whom.

Organization, covered

We have you covered when it comes to FDA compliance workflows. Save time by using our streamlined tools, and give it back to patient care.

Security is our priority

How secure is donor records?

We use physical, procedural, and technical safeguards to preserve the integrity and security of your donation information. We regularly back up your data to prevent data loss and aid in recovery. Additionally, we host data in secure SSAE 16 / SOC1 certified data centers, implement firewalls and access restrictions on our servers to better protect your information, and work with third party security researchers to ensure our practices are secure.

Transparent pricing

No contracts, no setup fees, no surprises

800 $
Monthly
Plus

Up to 100 donations per year

Up to 5 users

Standard support

21 CFR 1271 compliant

256 bit SSL encryption

HIPAA compliant

Custom branding

Audit Trail

Compliance Concierge

Multilingual donor questionnaires

FDA inspection checklists

3,200 $
Monthly
Premium

Up to 500 donations per year

Up to 15 users

24/7 prioritized support

21 CFR 1271 compliant

256 bit SSL encryption

HIPAA compliant

Custom branding

Audit Trail

Compliance Concierge

Multilingual donor questionnaires

FDA inspection checklists

7,400 $
Monthly
Enterprise

Up to 1,500 donations per year

Unlimited users

24/7 prioritized support

21 CFR 1271 compliant

256 bit SSL encryption

HIPAA compliant

Custom branding

Audit Trail

Compliance Concierge

Multilingual donor questionnaires

FDA inspection checklists

Get started today


Get started with Donor Records to streamline your tissue donation process, and take the guesswork out of FDA inspections.