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Timevolt / Exact dossier version filed with a regulator
Regulated products

Regulatory submission archive checklist with a dated exact-package copy.

Regulatory submission archive checklist with a dated exact-package copy. Keep your original source records together, then date the exact files. It does not prove identity, authorship, truth, location, consent, sending, delivery, approval, ownership, compliance, acceptance or who wins.

Try a file locally

Your photos and files stay on your device, so keep them.

EXAMPLE
Exact dossier version filed with a regulator
1 Nov 2026
Authority time: 14:02 UTC · example
Bitcoin block time: 14:10 UTC · example
Last checked: 15:02 UTC · example
✓ Dated◆ Permanent
Now keep it safe: three things
  1. Keep your photos and files unedited. The receipt only matches the originals. Put them in an album such as “My records”.
  2. Save this receipt to your camera roll.

    Keep the receipt file too. The image is a handy copy; checking needs the file.

  3. Email it to yourself.Email it to myself

    Your mail app opens a draft. Attach your receipt image and receipt file. Don’t attach your photos or documents. Timevolt does not send it or know whether it was sent.

Your record, one step at a time.

Your photos and files stay on your device, so keep them.

Local preview: files are fingerprinted here. Notes and progress stay in this browser. Keep downloaded copies; browser storage is not a backup.

0 items
How?

Add the exact original files for this part of the record. Keep them unchanged; a different export or edit has a different fingerprint.

Add link and screenshots

The link is recorded, not fetched or verified.

    0 items
    How?

    Record the date, time, place and who you spoke to. New notes are saved separately rather than editing an old note.

    How to keep notes that hold up
    Write it down

    By making a receipt you agree to the Terms and Privacy Policy. The Bitcoin record is permanent.

      By making a receipt you agree to the Terms and Privacy Policy. The Bitcoin record is permanent.

      How to keep notes that hold up

      Write notes as soon as you can. Keep the original account rather than replacing it later; the venue decides what weight it gets.

      1. Write it down straight away, on paper or in the box on a step.
      2. Put the date, time and place at the top, and who you spoke to.
      3. Use their words where you can; separate what you saw from what you were told.
      4. Sign or initial a paper note, photograph it and add the photo.
      5. Never edit an old note. Add a new dated entry when something changes. A device save time is not independent time evidence or proof of event order.
      Exact dossier version filed with a regulator
      Exact dossier version filed with a regulator

      01 · Keep the exact files

      Keep the original files for exact dossier version filed with a regulator. Include any existing photos, signed records and source-system exports.

      Records to keep: Submission package (PDFs, data tables) as filed

      Exact dossier version filed with a regulator

      02 · Date the file’s code

      Your device fingerprints the selected file or manifest. Dated follows an independent timestamp; Permanent follows Bitcoin anchoring.

      An independent time, tied to the exact bytes.

      Exact dossier version filed with a regulator

      03 · Keep the evidence

      Keep the original files and complete receipt separately, alongside any existing venue, signature and workflow records.

      Keep the originals too. A changed or compressed copy has a different fingerprint.

      Try a file. It stays here.

      Make a test receipt on this device.

      By making a receipt you agree to the Terms and Privacy Policy. The Bitcoin record is permanent.

      or drop a file here

      Real cases: why the saved copy matters.

      Real cases where dated records mattered. We don’t claim a time receipt would have changed the result.

      US federal · 2013

      Reported test dates must match the actual work

      A drug firm reported tests as done earlier than they really were. Its US arm pleaded guilty to drug-law and false-statement crimes. Separate civil claims ended in a settlement.

      Summarized on Oct 29, 2026

      Read the source ›
      US federal, Pennsylvania · 2023

      A clearance letter needs a real agency decision

      An employee made letters claiming medical-device clearance without filing the applications. The employee pleaded guilty to a serious drug-law offense. Sentencing was still to come in that report.

      Summarized on Oct 29, 2026

      Read the source ›

      Related cases

      US federal, Florida · 2023

      Trial records must reflect real participants

      Related: Invented clinical trial data

      Clinic staff invented trial data and listed people as trial participants when they were not. A jury found two people guilty of fraud crimes, and one also guilty of a false statement to the agency. Sentencing was still to come.

      Summarized on Oct 29, 2026

      Read the source ›

      What courts, schemes and regulators say.

      Positions below refer to the cited rule or record type, not endorsement of Timevolt. This service is not represented as an eIDAS qualified timestamp provider. A non-qualified timestamp does not receive the qualified timestamp presumption.

      Needs something else · United States FDA CDER/CBER covered drug and biological-product submissions; excludes device submissions

      FDA nonbinding2014guidance

      Receipt dates versus filing/review decisions

      Guidance distinguishes arrival date, technical deficiencies and later decision to file/receive for review. Applicable regulations take precedence; not an endorsement of a third-party timestamp.

      Source summary as of 2026-10-29. Check the current source and applicable local rules.

      Read the source
      Needs something else · US FDA CBER current electronic submissions

      CBER ESG NextGen FAQ

      ACK3 rejection, receipt and package handling

      Technical rejection means the repository could not process the package; weekend/holiday CBER dates and complete submission handling are source-specific. Timestamp does not establish transmission, center receipt or acceptance.

      Source summary as of 2026-10-29. Check the current source and applicable local rules.

      Read the source

      Other ways to do this

      Prices change. Check each provider’s site for current prices and service details.

      • Veeva Submissions

        Provides authoritative submission planning/content and archive workflow.

        Visit site

      • EXTEDO

        Provides regulatory document management, publishing, validation and review.

        Visit site

      • FDA ESG NextGen

        Provides official transmission, status and center receipt evidence.

        Visit site

      Related workflows.

      Quarterly user access review: the reviewer list, decisions and removals frozen as submittedAccess or license request, manager approval and grantQuarterly user access review: the list shown to the reviewer, each keep/remove decision and proof removals happenedHuman-in-the-loop approval before an AI agent executes a high-impact action (refund, payment instruction, production change, customer message)Who was physically present at a members' or condo board meetingHuman-made process record

      Proves / Doesn’t prove

      Proves

      A completed time receipt shows that the exact selected file existed by the independently witnessed time. You can check whether a later copy has the same bytes. It does not establish creation time, authorship, identity, event order, location or the truth of the contents.

      Doesn’t prove

      It does not prove identity, authorship, truth, location, consent, sending, delivery, approval, ownership, compliance, acceptance or who wins.

      It does not prove identity, authorship, truth, location, consent, sending, delivery, approval, ownership, compliance, acceptance or who wins.

      These are the bounds of a completed proof. The local tester does not establish any time. The chosen court, scheme or regulator decides what to accept.

      Questions, answered plainly.

      Your file stays on your device. During normal receipt creation, your device sends a randomized code made from its fingerprint, plus encrypted recovery data. It doesn't send the plain fingerprint or the random value that opens the code. Keep the original file and the complete receipt for checking. Privacy Policy.

      Does a dated dossier prove FDA received it?

      No. FDA's official gateway provides submission routing and center receipt status; a separate file date proves no transmission.

      Source summary as of October 30, 2026. Check the current source and its scope.

      Context for this answer
      Is an arrival date the same as review acceptance?

      No. The2014nonbindingguidance expressly separates receipt dates from later filing or receipt-for-review decisions.

      Source summary as of October 30, 2026. Check the current source and its scope.

      Context for this answer
      Can a package have a date and still be rejected?

      Yes. CBER lists technical rejection reasons including corrupt files and invalid formats.

      Source summary as of October 30, 2026. Check the current source and its scope.

      Context for this answer
      Should I preserve all files under one package reference?

      CBER says a complete non-eCTD submission should be under one core ID and does not gather separately submitted documents into a complete submission.

      Source summary as of October 30, 2026. Check the current source and its scope.

      Context for this answer
      Can a receipt certify the contents or clearance?

      No. The admitted forged-letter example shows why file existence and genuine regulator clearance are different facts.

      Source summary as of October 30, 2026. Check the current source and its scope.

      Context for this answer

      The file tester runs on your device. It does not issue a timestamp or take a payment.

      Keep the records you already have.

      Keep your original files and any existing official records while the receipt service is being prepared.