Sperm and egg cryobank software that ties every vial to the donor eligibility file behind it
A sperm and egg cryobank is an establishment that recovers, screens, tests, stores and distributes reproductive cells, which the FDA regulates as HCT/Ps under 21 CFR Part 1271. The rules are specific. A donor eligibility determination is required for both the oocyte donor and the semen donor of an embryo, anonymous semen must be quarantined and the donor retested at least 6 months after donation, and records are kept for 10 years. Neurobird holds the donor, the vial and the release decision on one record.
| Requirement | Status | Next due | |
|---|---|---|---|
| DNR-2190, oocyte cohort, eligibility determined, released | current | in 42d | |
| VIAL-88412, quarantined, awaiting responsible person sign off | due soon | in 9d | |
| DNR-2214, anonymous semen, retest due in 11 days | current | in 120d | |
| VIAL-88677, shipped to consignee, tracking entry closed | overdue | 3d late | |
| VIAL-88677, shipped to consignee, tracking entry closed | current | in 64d |
Tick a requirement to file evidence against it.
Neurobird Sperm Egg Cryobank in short
- Hold the donor screening, the test results and the eligibility determination as one dated file
- Keep anonymous semen in quarantine until the retest at 6 months is actually complete
- Print the accompanying summary of records with the vial rather than reassembling it later
- 6 months Minimum interval after the date of donation before a new specimen must be collected from an anonymous semen donor and retested for every agent required at donation, with directed donors excepted. 21 CFR 1271.85
- 10 years Retention period for records, counted at least 10 years after the date the HCT/P was administered, or after its distribution, disposition or expiration when the administration date is not known. 21 CFR 1271.270
- Pricing runs 249 to 1650 US dollars per month across 3 tiers. Early access is free.
What sperm banks, egg banks and fertility laboratories actually deal with
Why it stays broken
A cryobank is a laboratory, a warehouse and a distributor at once, and the regulation treats it as all three. Donor screening is clinical, quarantine and release are quality functions, and the tank is inventory, so the one thing that must stay joined, the vial and the eligibility record that lets it leave, is exactly the join that falls between three systems. Part 1271 is precise about what must accompany the unit and silent about the software that would hold it, so most banks run the join on a spreadsheet and a filing cabinet.
Under 21 CFR 1271.85, an anonymous semen donor must give a new specimen at least 6 months after the date of donation, and 1271.60 keeps that semen in quarantine until the retest is complete.
IVF is an ART procedure in which an egg is removed from a mature ovarian follicle and fertilized by a sperm cell outside the body.
Neurobird Sperm Egg Cryobank Compliance Platform
One record per donor and one per vial: the screening review, the test panel and its dates, the eligibility determination and who made it, the quarantine state, the distinct identification code on the container, and the consignee the unit finally went to.
- 1Hold the donor screening, the test results and the eligibility determination as one dated file
- 2Keep anonymous semen in quarantine until the retest at 6 months is actually complete
- 3Print the accompanying summary of records with the vial rather than reassembling it later
- 4Track any unit from the donor to the consignee and from the consignee back to the donor
What changes with Neurobird Sperm Egg Cryobank?
The same work, read left to right: how it runs today, and how it runs once the record is in one place.
| Today | With Neurobird Sperm Egg Cryobank |
|---|---|
| The vial is in the tank and the eligibility summary that has to accompany it is in a folder on somebody's desktop | Hold the donor screening, the test results and the eligibility determination as one dated file |
| A retest comes due on a donor whose units have already been quoted to a clinic, and nothing in the system said so | Keep anonymous semen in quarantine until the retest at 6 months is actually complete |
| Tracking from a consignee back to the donor takes an afternoon of phone calls because the code lives in three systems | Print the accompanying summary of records with the vial rather than reassembling it later |
Who is this for?
The same regulation, three different operations.
You ship to clinics nationwide
Anonymous units, a quarantine period and a retest that decides whether the inventory is sellable. You need the 6 month clock attached to the vial, not to a technician's memory.
You work in cohorts
Oocyte donors carry a 30 day specimen window and a cohort that gets split between recipients. You need the eligibility file to follow every straw out of the cohort.
You store for your own patients
Mostly autologous and partner units, which are excepted from the eligibility determination but not from the labeling. You need the exceptions applied correctly and printed on the label.
What the rules say about donor eligibility
The FDA subpart that governs reproductive donors, the testing and timing it imposes, and the records that have to travel with a unit once it is released.
Minimum interval after the date of donation before a new specimen must be collected from an anonymous semen donor and retested for every agent required at donation, with directed donors excepted.
21 CFR 1271.85Retention period for records, counted at least 10 years after the date the HCT/P was administered, or after its distribution, disposition or expiration when the administration date is not known.
21 CFR 1271.270Window around recovery for collecting the donor specimen used in testing, extended to 30 days before recovery for donors of oocytes, peripheral blood stem cells or bone marrow.
21 CFR 1271.80Communicable disease agents every donor specimen must be tested for: human immunodeficiency virus type 1, type 2, hepatitis B virus, hepatitis C virus and Treponema pallidum, with chlamydia and gonorrhea added for reproductive donors.
21 CFR 1271.85Time an establishment has after beginning operations to register with the FDA and submit a list of every HCT/P it manufactures, with the registration updated annually in December.
21 CFR 1271.21The tracking section, which requires a system that runs from the donor to the consignee and from the consignee back to the donor, using a distinct identification code that carries no name, social security number or medical record number.
21 CFR 1271.290How does Neurobird Sperm Egg Cryobank work?
Open the donor
Relevant medical records reviewed for the risk factors the rule names, the specimen collected inside the window the rule allows, and the testing laboratory recorded with its CLIA standing.
Hold and release
Units sit in quarantine, clearly distinguishable from released stock, until a responsible person has documented the eligibility determination and, for anonymous semen, the retest has come back.
Ship with the file
Each container carries its distinct identification code, the eligibility statement and the summary of records, and the tracking entry runs in both directions from the moment it leaves.
Sperm egg cryobank software questions, answered
Key terms
- What is a sperm and egg cryobank required to do before releasing a unit?
- Screen the donor by reviewing relevant medical records, test a specimen collected inside the window at 21 CFR 1271.80, and have a responsible person document an eligibility determination. Anonymous semen additionally stays in quarantine until the donor is retested at least 6 months after the donation.
- What are the tests every donor has to have?
- Under 21 CFR 1271.85 all donors are tested for human immunodeficiency virus types 1 and 2, hepatitis B virus, hepatitis C virus and Treponema pallidum. Donors of reproductive cells are additionally tested for Chlamydia trachomatis and Neisseria gonorrhea unless the recovery method rules out genitourinary contamination.
How long do the records have to be kept?
At least 10 years, counted from the date the unit was administered. Where the administration date is unknown the clock runs from distribution, disposition or expiration, whichever is latest, so a unit that sits in a tank for years extends its own retention.
Does this replace our laboratory information system?
No. Testing stays where testing happens. This is the eligibility and release side: which donor a vial belongs to, what state it is in, who signed it out, and what has to accompany it when it ships.
Can it handle autologous and partner units?
Yes, and it treats them as the rule does. Those units are excepted from the eligibility determination under 21 CFR 1271.90 but still carry mandatory labeling, so the exception is recorded as an exception rather than as a missing file.
Why we are building this
We went looking for records that carry real consequences and are still kept by hand, and cryobanks kept coming up. A vial is worth a great deal, it cannot leave without a file, and in a lot of buildings that file is a folder and a spreadsheet standing between a tank and a clinic. That is a record problem, and record problems are what we build. The sections of Part 1271 we read while scoping this are linked above, so you can check our reading of them instead of taking our word for it. If we have a step wrong, tell us and we will fix it.
Where the requirement comes from
Primary sources, straight from the regulators.
- 21 CFR 1271.45, donor eligibility requirements Why an embryo needs an eligibility determination for both the oocyte donor and the semen donor.
- 21 CFR 1271.85, donor testing by tissue type The panel for all donors, the genitourinary additions for reproductive cells, and the 6 month retest.
- 21 CFR 1271.80, general requirements for donor testing Specimen timing, the CLIA certified laboratory requirement and what makes a donor ineligible.
- 21 CFR 1271.55, records that accompany an HCT/P The distinct identification code, the eligibility statement and the summary of records on the container.
- 21 CFR 1271.270, records and length of retention The records management system, electronic retention and the 10 year clock that starts at administration.
- 21 CFR 1271.290, tracking Tracking in both directions, and what a distinct identification code may and may not contain.
How much does Neurobird Sperm Egg Cryobank cost?
Priced per establishment because registration, eligibility and tracking are all establishment level duties. Donors, vials and shipments are unlimited on every tier.
- One establishment
- Unlimited donors
- Vial inventory
- Eligibility file
- Multiple storage sites
- Quarantine and retest clocks
- Consignee tracking
- Label printing
- Multi establishment view
- Shared donor catalogue
- Inspection export
- Priority support
Get free early access
Early access means we load your donor list, your tank inventory and your current release checklist before you type anything, and the account stays free while we do it.
Straight answer on where this is: The software is in development. Nothing is purchasable today. Early access means you shape it and pay nothing while we build.
Prefer email? Write to office@neurobird.com and a person will reply. No autoresponder.