One unbroken trace from premix to treated animal
Sequencing and flush rules enforced before a batch starts, prescription limits treated as hard boundaries, and one unbroken trace from premix to treated animal. Validation-ready for Regulation (EU) 2025/2091, Regulation (EU) 2019/4 and 21 CFR Parts 225 and 226, and kept current with regulatory change as part of the product, at no extra cost.
Veterinary GMP is its own regulation now
For decades EudraLex Volume 4 covered human and veterinary manufacturing together. Since 16 July 2026 it does not. Two Commission Implementing Regulations carry veterinary manufacturing practice and veterinary active substance practice in their own right. The requirements remain close to human GMP, but guidance became binding regulation, and that changes the inspection posture rather than the paperwork.
Medicated feed is a second regime on top. Carry-over between batches, prescription validity, treatment duration and the prohibition on antimicrobial prophylaxis are all hard limits, and they are the limits an inspector tests first because they are the ones a production schedule quietly breaks.
The controls below run on the same compliance engine every industry uses.
What's tailored for veterinary
Not just compliance mapping — here's where the modules themselves work differently for this industry.
Sequencing rules block an unsafe production order before the batch starts, rather than warning about it after; flush and cleanout record themselves as evidence.
Withdrawal period computes and carries to the treated animal automatically, including cascade defaults under Article 115.
Continuous signal management submits suspected adverse events on the 30-day clock, with the qualified person named on the file.
20 controls, 7 standards
Select a standard to filter
Working draft, not a certified mapping — our own reading of each framework's published scope, not a legal determination.
Coverage by geography
We watch the regulations so you don't have to
Standards don't stay still. The Compliance Engine tracks every one that applies to you: when a rule changes, it tells you what it affects, updates the system, and re-validates before anything goes live. You don't file a change request. It's already handled.
Medicated feed regime built alongside the GMP split
Carry-over limits, prescription validity and the antimicrobial prophylaxis prohibition shipped as hard limits in the same release that split veterinary GMP from human GMP.
Veterinary GMP split from human GMP
EudraLex Volume 4 no longer covers human and veterinary manufacturing together. Two Commission Implementing Regulations now carry veterinary manufacturing practice and veterinary active substance practice in their own right — guidance became binding regulation.
Every update runs through the same validation discipline as the platform itself — tested against the workflows it touches before it reaches a single client's floor. Nothing ships because a regulation changed; it ships because the change passed.
Withdrawal periods the system computes
Where a product is used off-label under the cascade, Article 115 sets statutory minimums rather than leaving it to judgement. The pack applies them and records the result against the treated group.
Three retention clocks, one plant
This is where veterinary operations most often drift, because the record classes look alike and the obligations do not.
Reporting clocks the system runs
| Jurisdiction | Trigger | Clock |
|---|---|---|
| European Union | Any suspected adverse event, to the Union pharmacovigilance database | 30 days |
| United States, 21 CFR 514.80 | Product or manufacturing defect report | 3 working days |
| United States, 21 CFR 514.80 | Serious and unexpected adverse drug experience | 15 working days |
| United States, 21 CFR 514.80 | Periodic drug experience reports | Every 6 months for 2 years, then annually |
Validation readiness
The controls above are enforced in the architecture, not configured on top of it.
- Validation packs (URS, IQ, OQ, PQ, RTM, GAMP 5) are available on the Dedicated tier.
- ISO 27001 certification is in progress.
- Inspection readiness is scored continuously by the Compliance Engine, not assembled the week before an audit.
For the technical detail behind these controls — encryption, access control, audit trail mechanics and backups — see Infrastructure & Security. For what sits in each workspace, see Modules.
Have a compliance requirement to walk through?
Tell us about your regulatory environment and we'll show you exactly how Factro fits.