Not a policy binder. Not a quarterly review. A deterministic rules engine that evaluates every operational event against your actual regulatory requirements, before the record is committed, not after the audit finding.
We codify the regulations you operate under into executable rules, then layer a governed AI copilot that translates every outcome into plain-language guidance with a citation attached. Delivered in four-week cycles, production-ready at the end of each one.
The regulation is clear. Your SOP documents it. Someone trained the team on it. Then a technician on a Tuesday afternoon hits a case the SOP does not quite cover, and the only thing between your organization and an audit finding is whether that person remembers correctly and has time to check.
That is not a training problem. It is an architecture problem.
The requirement exists in a policy document nobody opens. The event gets recorded without the required field, the record is committed, and the gap surfaces months later when an inspector asks for the trail.
Staff correctly recall a requirement and apply it to a case where a different rule governs. A Schedule II documentation standard applied to a Schedule III shipment. Both facts accurate. The conclusion is wrong.
An inspector asks how a decision was made. The evidence exists across an EHR, a spreadsheet, an email thread and someone’s memory. Reconstructing it costs a week of senior staff time under deadline pressure.
Compliance Intelligence has two layers, and the separation between them is the entire point.
We codify your regulatory requirements into deterministic, versioned rules: executable logic that evaluates each operational event and returns a pass, warn or fail outcome with an immutable audit record. No probability. No inference. If a rule fires, you can see exactly which requirement was evaluated and why.
When a rule fails, your team does not see an error code. They see what failed, why it matters and the specific steps to resolve it, in operator language, with a citation to the exact regulation behind it. The copilot never interprets regulation and never decides what is compliant. It translates an outcome the rules engine already validated.
That division of labor is why this architecture holds up in a regulated environment when a general-purpose AI assistant does not.
Every engagement starts with your actual requirements, not a template. These are frameworks we have already modeled into executable rules.
| Framework | Scope | What the rules engine enforces |
|---|---|---|
| DEA / Controlled Substances Act | Federal: all controlled substance handling | Receipt completeness, perpetual inventory, biennial count timing, record retention windows, custody chain integrity |
| DSCSA | Federal: prescription drug supply chain | Lot-level traceability, transaction history completeness, trading partner verification, suspect product handling |
| HIPAA | All PHI-handling entities | Role-based access enforcement, minimum necessary access, audit log completeness, disclosure tracking |
| USP Chapter 797 | Sterile compounding operations | Environmental monitoring cadence, beyond-use dating, batch release documentation, personnel qualification currency |
| State Board of Pharmacy | State-by-state requirements | Inventory cadence, technician supervision ratios, policy and procedure compliance, licensure currency |
| FDA 21 CFR Part 820 / QMSR | Medical device manufacturers | Design history file completeness, CAPA closure integrity, document control, supplier qualification |
| FDA 21 CFR Part 803 (MDR) | Medical device adverse event reporting | Reportability determination, 30-day and 5-day window tracking, event classification consistency |
| SOC 2 | SaaS handling sensitive client data | Security, availability, processing integrity and confidentiality control evidence |
Operating under something not on this list? The architecture is framework-agnostic. If the requirement can be written down, it can be codified.
Enterprise pharmacy operations platformThe rules engine. 28 rules across seven workflow families (Receiving, Movement, Waste, Audit, Expiration, Ordering and Credential) covering DEA, DSCSA, HIPAA, USP 797 and state Board of Pharmacy requirements. Load-tested at 35 events per second with p95 latency of 2.9 seconds.
The AI copilot. Plain-language guidance for pharmacy technicians on every outcome: what failed, why it matters, how to fix it, and the regulation behind it. Validated across a 30-scenario structured evaluation.
Read the case study →The rules engine determined what was compliant. The copilot only explained an outcome that had already been validated, with a citation, every time.
Software companies serving pharmacies that need compliance evaluation embedded in their product: DEA, DSCSA, USP 797 and state board requirements enforced at the transaction level.
Organizations handling controlled substances or sterile compounding where documentation timing and completeness carry direct regulatory exposure.
Pre-production and scaling manufacturers facing QMSR documentation requirements, MDR reportability determinations and post-market surveillance obligations that are outgrowing manual review.
Companies whose product touches a regulated process and who need the compliance layer to be defensible, not just present.
We scope each cycle to a single workflow family or regulatory framework. Narrow enough to finish completely. Real enough to matter operationally.
We work with your compliance team to map the actual requirements, connect to source systems and establish the governance model.
We codify requirements into deterministic, versioned rules and validate outcomes against your real operational records.
We layer cited explanations, add audit logging and access controls, and run the structured evaluation set.
Deployment into your environment, team walkthrough, documentation and the roadmap for expansion.
At the end of week four you decide whether to run another cycle. Luveo ran two. Most clients run three to six as they expand coverage across workflows and frameworks. How we work →
If we can scope it into a cycle, we will tell you exactly what that includes and what it costs. If we cannot, we will tell you that too.
Book a 30-minute scoping call →Hi. Ask me about our services, the four-week cycle, PHI and security, or the Luveo case study. Every answer links to where it comes from.