The easiest way to manage your digital donation records
Donor Records gives your team the tools it needs to be organized and compliant when it comes to determining FDA tissue donation eligibility.
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.