Make every raw result defensible from the moment it is produced.
Seal protocols, assays and instrument outputs with a UTC-synchronised external timestamp, without uploading proprietary data to another SaaS platform.
Evidence record
Biotech & Clinical
The problem
What makes this hard to prove today
Most evidence problems are not about whether a file exists. They are about whether you can show what it was, when it existed and that it has not changed since.
Local workstation clocks are not audit-grade
Device time can be changed and is weak evidence in an inspection. Regulators expect a time source outside the operator's control.
Heavy ELN and LIMS validation is out of reach
Smaller labs, academic core facilities and spinouts need a lightweight way to seal records without a long IQ/OQ/PQ programme.
Raw outputs can be edited before submission
Chromatography peaks, mass-spec output, blots and sequencing files need an early, tamper-evident anchor.
Changes need a documented reason
Annex 11 and ALCOA+ expect an audit trail and a reason for modification, not just a final file.
What you get
An evidence pack you can actually use
IP Vault produces the sealed record. Your team keeps control of the files and decides who receives the verification link.
Protocol and assay seals
Hash a protocol, raw output or dataset without sending the underlying file to IP Vault.
Externally sourced time
The digest is signed by an eIDAS-qualified timestamp authority and anchored to Bitcoin.
A change record
Record why a revision was made and link it to the prior certificate for a traceable history.
An inspector-ready package
Declaration, manifest and proof files in a ZIP your team keeps and controls.
How it works
Three steps, no new storage platform
Hash the record locally
The assay, protocol or dataset is fingerprinted in memory. The raw file is not uploaded to IP Vault.
Seal it with external time
The digest is timestamped through the qualified authority and anchored to the Bitcoin blockchain.
Store and hand over the evidence
Keep the evidence pack in your own cloud or local archive and share the verification record with QA, a partner or an auditor.
Regulatory context
Designed around regulated record-keeping
IP Vault is designed to produce an ALCOA+-aligned evidence record. It does not replace a validated ELN, LIMS, QMS or your own Part 11 compliance programme.
Who it is for
Built for teams that have to show their work
Common questions
The short answers
Does this make us Part 11 compliant?
Do you receive our raw data?
Can we keep our existing LIMS?
Can we record why a record changed?
Create the record now, decide who sees it later
Start with a single protection run. Keep the archive, share the verification link, and add revisions when the work changes.
Other solutions