The evidence

Citations and the audit trail

What a citation contains, how the hash-chained Part 11 record makes a run tamper-evident, and how to re-open a verdict long after the meeting that used it.

Two mechanisms make an assessment defensible rather than merely persuasive. Citations say where each number came from. The audit trail proves the record has not changed since.

They serve different readers: the citation is for the colleague who does not believe you, the audit trail is for the auditor who arrives two years later.

What a citation contains#

A citation is not a footnote to a source name. It is enough information to reproduce the number yourself.

The source
Which public database or record the figure came from.
The query
What was actually asked of that source — the filter that produced this figure and not a different one.
The snapshot date
When the record was read, so the figure can be checked against the record as it stood.
The link
A route back to the public record itself, so you can read the original rather than our summary of it.

The hash-chained record#

Every run writes to an append-only audit record aligned to 21 CFR Part 11. Each entry references the cryptographic hash of the entry before it, so the record forms a chain.

  1. Cited

    Each figure is written with its source, its query and the snapshot date it was read on.

  2. Hashed

    Citations, inputs, scorer versions and outputs are written to the append-only record, each entry referencing the hash of the entry before it.

  3. Replayable

    Export the chain and replay the run. A retroactive edit breaks the chain and is detectable — which is what tamper-evident means in practice.

Re-opening a decision later#

The point of all of this is what happens months after the decision. A verdict produced today can be re-opened, and everything needed to interrogate it is still attached to it.

  • The inputs the run used, including which of them you stated and which were modelled.
  • The exact public records the run read, at the version it read them.
  • The analysis versions that produced each number.
  • Who signed off on what, when, and with what stated reason.

When the evidence moves under a signed decision#

Public records get superseded. A label is updated, a trial reports, a patent lapses. A signed decision that rested on the old version does not silently become wrong — it gets flagged.

When a cited source behind a signed deliverable is superseded, the task is re-opened as requiring a fresh signature. The original signature and its evidence stay in the record; a new one is required to carry the decision forward.

Related

Next

Your team

Expert roles & sign-off

Seven expert workspaces draft the documents your decision needs; your team reviews them and signs with a Part 11 electronic signature that pins the evidence it was based on.

Open

The evidence

Where the numbers come from

Around fifty live public-data connectors, seven of them load-bearing, each pinned to the snapshot it was read from — and an honest ledger of the ones that returned nothing.

Open

Your data

Your data

What the platform stores, where it is processed, what it is never used for, and how long it is kept — in plain terms, with the legal detail linked.

Open

See a verdict you can actually check.

Send us a protocol — or just a molecule and an indication. We'll return a fully cited feasibility assessment you can trace, line by line, back to public data — yours to defend in a bid, take to your board or investment committee, or hand to a regulator.

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