Legal Framework:

Plain-English Summary:

Olexian Instrumentation is evidence tooling. It turns a run into a portable, offline-verifiable evidence bundle that helps teams answer:

“What ran? What changed? Can we prove it later?”

“It does NOT certify compliance, guarantee safety, or replace regulatory judgment.”

A boundary map with two sections: the left side titled 'OLEXIAN IS' in a blue box listing 'Instrument, Evidence generator, Deterministic, Offline-verifiable'; the right side titled 'OLEXIAN IS NOT' in a red box listing 'A compliance authority, A safety guarantee, A cloud service, A monitoring/telemetry platform'; a note below stating evidence, not certification, does not guarantee compliance or safety, runs locally, offline verification supported.

Greetings Scientists,

Olexian Instrumentation is a for-profit software project built to strengthen trust in high-consequence engineering, by making systems easier to audit, reproduce, and explain. Our products produce evidence artifacts that help teams answer: what ran, what changed, and whether results can be independently verified later, offline, using the same recorded evidence.

Olexian Instrumentation does not certify regulatory compliance, does not guarantee safety outcomes, and does not replace the judgment of regulators, auditors, or the customer’s own quality and safety programs. Our outputs are evidence bundles and verification results; interpretation, risk acceptance, and compliance decisions remain the responsibility of customers and/or regulators. Olexian Instrumentation does not control or alter customer system behavior, and it is not a monitoring or telemetry platform by default.

This project was created from a genuine desire to help the human race build safer technologies by making engineering claims more testable, reviewable, and resilient under scrutiny. We believe that clear boundaries, verifiable artifacts, and fail-closed verification practices reduce preventable risk and improve accountability—especially where mistakes carry real consequences.

For avoidance of doubt, nothing in this letter or in Olexian’s materials should be construed as legal, regulatory, or compliance advice. Customers should consult their own qualified legal counsel and regulatory advisors to determine how to apply Olexian’s evidence outputs within their specific obligations, jurisdictions, and risk posture.

Sincerely,
Frederick White (Founder)
Olexian Instrumentation

Naming Notice:

Naming notice: We have renamed our public product from OCP (an internal codename) to,

OEP — Olexian Evidence Platform. We are actively updating our website and materials to reflect this change. If you encounter “OCP” anywhere in public-facing content, please notify our team so we can correct it and keep the naming consistent.

What We Offer:

Evidence Bundles (Core Output):

We provide tooling that can produce a self-contained evidence bundle for a run, which may include:

  • A record of inputs, toolchain context, and outputs (“what ran”).

  • Integrity metadata enabling later verification that recorded artifacts were not altered after the run.

  • Structured PASS/STOP outcomes when required evidence is missing/unknown/altered.

  • Deterministic verification reports when the workflow supports deterministic replay/verification.

Offline Verification (Key Property):

Evidence bundles are designed to be verified later, offline, by independent parties using the provided verification process.

Local-First Operation:

Olexian is designed to run locally in your environment. You control where your artifacts live and who receives them.

What we do NOT Offer:

Not Compliance Certification:

  • We do not certify compliance with FDA/CE/ISO/IEC or any other regulatory regime.

  • We do not act as a notified body, auditor-of-record, or compliance authority.

Not a Safety Guarantee:

  • We do not guarantee safety outcomes, correctness of your system, or fitness for a specific medical/clinical use.

  • Evidence is not a substitute for hazard analysis, clinical evaluation, or human oversight.

Not a Monitoring / Telemetry Platform:

  • We do not provide continuous monitoring services by default.

  • We do not provide surveillance, behavioral tracking, or “always-on” data collection.

Not a Control System:

Olexian does not change your system’s behavior and does not decide outcomes:

  • No actuation.

  • No operational decisions.

  • No pass/fail compliance verdicts.

Customer Responsibilities:(Ownership & Liability Clarity)

You (the customer) remain responsible for:

  • System design, validation, and safe operation.

  • Correct configuration and use of Olexian in your workflow.

  • Interpreting evidence outputs and deciding what they mean for release, submission, or audit contexts.

  • Meeting regulatory requirements and engaging qualified auditors/regulators where required.

Definitions (to Reduce Ambiguity):

Evidence Bundle: A packaged set of artifacts + metadata produced from a run intended for later verification.

Verification: Checking that artifacts match recorded integrity metadata and that deterministic checks (where applicable) reproduce expected results

PASS/STOP: An internal evidence completeness/integrity outcome, not a regulatory approval.

Deterministic: Under declared constraints (e.g., pinned environment/toolchain/inputs), identical inputs produce identical verification outputs.