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Timevolt / Validated system release: test evidence and QA approval locked before go-live
Life sciences IT

Keep the exact test package and QA release approval together.

Keep the exact test package and QA release approval together. Keep your original source records together, then date the exact files. It does not validate a system, establish a signer’s authority, prove tests happened, or satisfy electronic-record rules by itself.

Try a file locally

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

EXAMPLE
Validated system release: test evidence and QA approval locked before go-live
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.
      Validated system release: test evidence and QA approval locked before go-live
      Validated system release: test evidence and QA approval locked before go-live

      01 · Keep the exact files

      Keep the original files for validated system release: test evidence and qa approval locked before go-live. Include any existing photos, signed records and source-system exports.

      Records to keep: Test scripts, results, deviation list, QA approval

      Validated system release: test evidence and QA approval locked before go-live

      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.

      Validated system release: test evidence and QA approval locked before go-live

      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

      Related cases

      Related cases from nearby fields. We don’t claim a time receipt would have changed the result.

      US FDA oversight · 2020

      Keep raw lab files and a change history

      Related: lab data access and audit trails

      The FDA said a lab let staff delete raw files and change dates. Its change log was not working. A warning letter called the lab's reply too weak and asked for fixes.

      Summarized on Oct 29, 2026

      Read the source ›
      US FDA oversight of India manufacturer · 2023

      Keep failed test results with the release file

      Related: drug manufacturing validation records

      The FDA found missing source pages, weak audit trails and an omitted failed result from a drug validation batch. It called the firm's reply too weak and asked for wider review and fixes. This was a warning letter.

      Summarized on Oct 29, 2026

      Read the source ›
      US FDA oversight · 2022

      Keep the reasons for deleted tests

      Related: laboratory test system controls

      The FDA found deleted test methods, stopped runs and changes without sound controls. It asked for system lists, separate access rights and a plan to fix audit trails. The warning's later closure was not checked.

      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 · US FDA regulated records within scope

      FDA electronic-record inspections

      21 CFR 11.10 Controls for closed systems

      The rule addresses validation, access, complete copies, record protection and secure time-stamped audit trails. A hash or external date stamp alone does not provide these controls.

      Source summary as of 2026-10-28. Check the current source and applicable local rules.

      Read the source
      Needs something else · US medical-device production and quality systems

      FDA software assurance review

      Computer Software Assurance guidance February 2026

      Current risk-based software-assurance guidance concerns production and quality-system software; preserve applicable testing and assurance evidence rather than asserting that a receipt is validation.

      Source summary as of 2026-10-28. Check the current source and applicable local rules.

      Read the source
      Needs something else · US FDA records

      FDA electronic-record inspections

      Part 11 scope and application guidance

      Applicable predicate-rule retention and availability obligations remain. Copies and archived formats must preserve record content and meaning; this guidance does not endorse a hash or external date receipt as compliance.

      Source summary as of 2026-10-28. 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.

      • ValGenesis

        Provides digital validation platform with test execution, traceability and lifecycle records.

        Visit site

      • Veeva Validation Management

        Provides controlled validation workflow captures tasks, user actions, signatures and reporting in an audit trail.

        Visit site

      • Controlled paper or hybrid package

        Keeps paper and electronic records together under the applicable requirements.

        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 validate a system, establish a signer’s authority, prove tests happened, or satisfy electronic-record rules by itself.

      It does not validate a system, establish a signer’s authority, prove tests happened, or satisfy electronic-record rules by itself.

      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.

      Is this a validation platform?

      No. It dates a selected release-evidence package. Testing, approvals and controlled system records still need their own process.

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

      Context for this answer
      Does a time receipt meet Part 11?

      A timestamp alone does not provide the validation, access, copying and record-history controls described by the rule.

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

      Context for this answer
      Which software-assurance guidance is current?

      The FDA page opened for this research identifies the February 2026 final guidance and says it supersedes the September 2025 version.

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

      Context for this answer
      Can I replace raw system records with screenshots?

      Not automatically. FDA has criticised static outputs that failed to preserve the complete dynamic laboratory record.

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

      Context for this answer
      What belongs in a release package?

      Keep the test version, results, unresolved-deviation record and approved release copy, together with references to their controlled originals.

      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.