Pharma & Life Sciences · the same standard, extended
The accountability standard, read in life sciences.
Electronic records, signatures, and trial data engineered to satisfy 21 CFR Part 11 — tamper-evident and independently verifiable, not validated once and trusted. Instantiated for Part 11 and ALCOA+ data integrity. The eight axes never change; only what they mean here does.
Don't trust us — the integrity of this page is recomputable in your own browser
Patent-pending — U.S. Provisional 63/921,717
For life sciences
Who it's for, what it promises, how it's proven.
How it works
From a record to a proof, in four moves.
The mechanism is the same for every record and every access. Nothing here asks you to trust a vendor's word — the last step is something you do yourself.
The record is written
A record (or an edit to one) is committed and bound into an append-only chain — sensitive fields encrypted at the record.
Every access is stamped
Each read or change becomes a WORM event — who, what, when — that nobody can quietly remove or rewrite after the fact.
Access is gated
A person authenticates with a phishing-resistant passkey; access is least-privilege and the access itself is recorded.
You recompute the proof
Open the verifier and recompute the hash yourself. If the record changed, the hash changes — integrity resolves to math, in your browser.
One framework · eight axes
The eight axes — read in life sciences.
The canonical axis codes, names, and roles are frozen by the engine and shown unchanged. Only the gloss — what the axis means in life sciences — is specific to this domain. No axis is relabeled; no named entity is measured.
PO · Physical & Outdoor
Somatic foundation
Manufacturing & lab foundation — GMP facilities, equipment qualification, and the soundness of the operations record.
NM · Nutritional & Metabolic
Somatic foundation
Materials & resource intake — APIs, reagents, and the validated supply that feeds production and research.
ER · Emotional & Relational
Resilience wing
Patient, investigator & partner trust — relationships across trials, sites, and the patients ultimately served.
SC · Social & Communal
Spirit term
Regulatory & scientific standing — coherence with FDA / EMA, sponsors, and the scientific community.
RS · Religious & Spiritual
Resilience wing
GxP ethics & data-integrity adherence — fidelity to ALCOA+, GCP / GMP, and the duty to the patient.
ES · Environmental Stewardship
Environment term
Records & sample stewardship — custody of trial data, batch records, and chain-of-custody for samples.
TA · Technological & Adaptive
Technology term
Validation & systems modernization — CSV, Part 11 tooling, and adaptive lab and manufacturing systems.
PV · Purposeful & Vocational
Purpose exponent
Approval & vocational fitness — licensure, GxP certification, and fitness to develop and produce.
The composite is multiplicative — you can't paper over a missing pillar to lift the score — and the consistency exponent rewards steadiness across all eight. See the canonical eight axes →
Engineered for the rules, not badged against them
How the standard maps to 21 CFR Part 11 & ALCOA+.
We don't ask you to take a certificate on faith — a logo on a page proves nothing you can check. Each obligation maps to a mechanism you can inspect or recompute — the difference between asserting compliance and demonstrating it.
| Obligation | How the standard satisfies it | Status |
|---|---|---|
21 CFR §11.10(e)Audit trail (time-stamped, retained) |
Every access is an append-only, chain-stamped WORM event — who, what, when — that no one can quietly remove. | Built |
21 CFR §11.10(a)Validation; accurate, reliable records |
Records bind into a SHA3 hash-chain; any alteration changes the leaf and is detectable. You recompute the hash yourself. | Built |
21 CFR §11.10(b)Accurate, complete copies of records |
A verifiable export — a portable, independently-checkable record of provenance and access that an auditor can re-verify. | Built |
21 CFR §11.200Electronic signature controls |
WebAuthn passkey sign-in — phishing-resistant, with no shared secret to steal or replay. | Built |
21 CFR §11.10(c)Protection of records for accurate retrieval |
Retention classes and legal hold are enforced on the chained record; even disposition is itself a logged, tamper-evident event. | Built |
ALCOA+Attributable, Legible, Contemporaneous, Original, Accurate (+ Complete, Consistent, Enduring, Available) |
End-to-end provenance — each step is a chained leaf, so chain-of-custody is reconstructable and tamper-evident from creation onward. | Built |
CSV / EU Annex 11Computer-system validation package |
A validation package and IQ/OQ/PQ evidence for a regulated deployment are roadmap deliverables — ask us where each system stands. | Roadmap |
Status is honest. Each row is Built (the mechanism exists in the gold stack) or Roadmap (the Pharma / Life Sciences-specific instantiation is planned). Medicine is the one live, shipped domain today. This maps mechanism to obligation — it is not a claim of certification, because the standard is to prove integrity, not badge it.
Same engine · illustrative archetype
An illustrative life sciences archetype, scored by the same engine.
Illustrative profile: a developer / manufacturer with rigorous GxP discipline and data-integrity controls, strengthening end-to-end provenance and independent verification.
These are illustrative inputs — not a measurement of any named entity. Feed them through the same public compute() on The Standard page, change any slider, and recompute it yourself.
What you get
The standard, in your hands.
- The accountability score — your eight axes scored by the public engine, recomputable by anyone.
- The tamper-evident record — records and access history on an append-only chain.
- The in-browser verifier — recompute any record's integrity yourself, no trust required.
- A verifiable export — a portable, independently-checkable account of who-saw-what, when.
- Encrypted data at rest — field-level AES-256-GCM on sensitive fields (rolling in).
- A standard, not a lock-in — the proof is open math you can run even if you leave.
Questions QA and a validation lead ask first.
Do you provide a Part 11 / CSV validation package?
A validation package (IQ/OQ/PQ, traceability) for a regulated deployment is roadmap work; the underlying audit-trail, integrity, and e-signature mechanisms are built. Talk to us about your validation scope.
How does this fit with my eTMF / LIMS / MES?
It adds tamper-evident provenance and independent verification alongside your validated systems. Tell us your stack.
If you go away, can we still verify our trial data?
Yes. Integrity is open math over an append-only chain — independent re-verification does not depend on us.
What's live today versus on the roadmap?
Medicine is the live, shipped anchor. For life sciences the core Part 11 mechanisms are Built; the validation package is Roadmap.
Why one framework covers it
The same formula, the same chain, the same verifier.
Accountability has the same shape in life sciences as anywhere else: a foundation, the relationships built on it, the capability to adapt, and the consistency to sustain it. The proof is identical — and it resolves to math, not to our word.
One formula over eight axes
The composite is multiplicative and the consistency exponent rewards steadiness — so you can't fake a missing pillar to lift your standing. The same engine that scores every domain.
One append-only chain
The record — and every access to it — sits on a chain where nobody can quietly rewrite the past. Tamper-evident by construction, not by promise.
One verifier anyone can run
Don't trust us — recompute the chain in your own browser. Every domain runs the exact same proof. Open the verifier →
Looking for another regulated world? The same standard reads in all ten domains. Medicine is the one that is live and shipped today — see the live anchor →