Reproducible
by design.
Regulated R&D can't run a black box in a validated path. If a result can't be reproduced bit-for-bit, audited end-to-end, and explained without an opaque model in the trust path, it doesn't survive a Part 11 inspection. We serve pharma R&D one way — software — anchored on Heisen, deterministic compute that returns the same answer every time and shows its work. No crane, no rigging, no hardware. Just compute you can validate and software built around it.
Deterministic
Heisen compute — same input, same output, every run
21 CFR 11
Electronic-records + signatures compliance built in
GAMP 5
Computerized-system-validation-ready by design
0
Black-box models in the GxP-validated decision path
Six exposures only deterministic software controls.
Pharma R&D risk lives in the compute + the data, not on a shop floor. The exposures below are why a black-box model fails a regulated R&D path and why deterministic, audit-trailed software is the only thing that holds. Every Maxor engagement in this vertical addresses them explicitly.
Irreproducible result
A result you can't reproduce bit-for-bit isn't evidence — it's an anecdote. Stochastic pipelines drift between runs. Heisen returns the same output for the same input, every time, so the result is defensible under inspection.
21 CFR Part 11 non-compliance
Electronic records + signatures in a regulated system must be attributable, secure, and tamper-evident. A system that can't prove who did what, when, and that the record hasn't changed, fails Part 11 — and the data with it.
Data-integrity (ALCOA+) breach
Attributable, Legible, Contemporaneous, Original, Accurate — plus Complete, Consistent, Enduring, Available. A gap in any of these invalidates the data lineage. The software enforces ALCOA+ at the point of capture, not in a retrospective clean-up.
Black-box model rejection
A regulator won't accept a decision driven by a model nobody can explain. Opaque ML in the trust path is a finding waiting to happen. Heisen keeps the decision path deterministic + explainable — every signal traceable to its input.
Validation burden (CSV)
Computerized-system validation is a tax on every non-deterministic, poorly-documented system. Software designed for GAMP 5 from the start — deterministic, documented, audit-trailed — collapses the validation burden instead of inflating it.
IP + data sovereignty
Drug-discovery data is the crown-jewel IP. Sending it to an opaque foreign cloud is a sovereignty + confidentiality exposure. Sovereign Canadian deployment keeps the compute + the data in-jurisdiction, on hardware you control.
One lane. Software, anchored on deterministic compute.
There's no hardware engagement for us in pharma R&D — no lift, no rigging. We serve the sector entirely through software, built on Heisen deterministic compute. Six concrete fits.
Deterministic compute engine
Heisen — deterministic, reproducible compute as the substrate. Same input, same output, every run, every signal explainable. The compute layer a Part 11 / GAMP 5 path can actually be validated against.
Cheminformatics + molecular modeling
Custom modeling + screening pipelines built on deterministic compute — reproducible results, audit-trailed parameters, no run-to-run drift to explain to an inspector.
ELN / LIMS integration + lab informatics
Custom integration across electronic lab notebooks, LIMS, and instrument data — one audit-trailed data plane instead of brittle point-to-point exports that break the lineage.
Data-integrity + ALCOA+ enforcement
Software that enforces attributability, contemporaneity, and tamper-evidence at the point of capture — the data-integrity posture an inspection looks for, built in rather than bolted on.
21 CFR Part 11 records + e-signatures
Electronic-records + electronic-signature infrastructure that meets Part 11 — attributable, secure, audit-trailed — wrapped around the custom application instead of retrofitted.
Clinical + research data platform
Custom platforms for research + clinical data with the lineage, access control, and sovereign deployment regulated R&D requires. Heisen embeds by API into your existing stack.
Pharmaceutical R&D in the field
From sector context to the lifts we engineer — a look at where this work happens.
The standards we build to.
Our deliverable is software, so the standards are the ones a regulated computerized system is validated against. Every build is designed to satisfy them from the first commit — not to be retrofitted into compliance later.
Electronic records + electronic signatures
The FDA rule governing electronic records + signatures. Our software is designed for attributability, security, and tamper-evidence — the Part 11 controls built into the application, not added at validation.
Good Automated Manufacturing Practice
The framework for computerized-system validation. We build to GAMP 5 from the start — deterministic, documented, risk-categorized — so validation is a confirmation, not an excavation.
Good practice (GLP / GMP / GCP)
The umbrella of good-practice regulations across lab, manufacturing, and clinical. Our software respects the GxP path the data has to travel — deterministic compute keeps that path defensible.
Data-integrity principles
Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, Available. Enforced at the point of capture by the software, the way an inspector expects to see it.
Computerised systems (EU GMP)
The EU GMP counterpart to Part 11 for computerised systems. Builds destined for EU-regulated work are designed to satisfy Annex 11 in parallel with Part 11.
International Council for Harmonisation
ICH guidelines (Q-series quality, E-series efficacy) shape the data + process our software supports. Referenced so the platform fits the regulatory submission it ultimately feeds.
One pillar of four. Software, full stop.
Pharma R&D is the cleanest software-only engagement in the portfolio. Three of the four pillars don't apply — and we say so. The fourth is the entire story.
Sealed plans + emergency response
Not applicableNot applicable. Pharma R&D has no crane lifts for us — there's no heavy-equipment engagement in a research lab. Lift planning isn't part of this vertical.
Distribution + training + implementation
Not applicableNot applicable. CRANEbee simulates multi-crane operations — none exist in a research environment. No crane, no simulation.
Distribution + advisory + training
Not applicableNot applicable. Pharma R&D doesn't run the heavy-material handling Murlink serves. The engagement here is purely software — no rigging.
Deterministic engineering platform
The entire engagement. Heisen deterministic compute as the substrate — reproducible, audit-trailed, no black-box in the validated path — plus custom software (Part 11, GAMP 5, data integrity, cheminformatics, ELN / LIMS integration). Sovereign, Canada-built. Heisen embeds into your existing stack by API.
Deterministic R&D compute, built for the validated path.
In pharma R&D, the custom build is the whole engagement — and it's anchored on Heisen. We build deterministic, audit-grade, Part 11-ready software for research : same engineering posture, same team from kickoff to go-live, sovereign by default. Reproducible compute the regulator can actually accept. Engineered in Canada, owned by you.
Heisen — our deterministic intelligence layer — is optional on any build: embed it or not, your call. Either way it plugs into a fresh custom app or your existing third-party software via API.
Heisen deterministic modeling pipeline
Cheminformatics + molecular-modeling pipelines on Heisen deterministic compute — reproducible bit-for-bit, audit-trailed parameters, explainable signals. The model output survives a Part 11 inspection because it can be reproduced and explained.
Part 11 / GAMP 5 data platform
An electronic-records platform with built-in attributability, e-signatures, and ALCOA+ enforcement — validation-ready by design, so CSV confirms the system instead of excavating it.
ELN / LIMS integration + sovereign data layer
A deterministic integration layer across ELN, LIMS, and instrument data with sovereign Canadian deployment — the crown-jewel R&D data stays in-jurisdiction, on hardware you control.
Scope your pharma R&D software build.
Tell us the research workflow, the systems it has to talk to, and the regulatory path. A senior lead responds within one business day with a scoped engagement and a path to first deliverable.