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.
Healthcare AI
PCCP change record checklist: preserve the authorized plan, exact software version and validation evidence.
PCCP change record checklist: preserve the authorized plan, exact software version and validation evidence. Keep your original source records together, then date the exact files. It does not establish FDA authorization, successful validation, correct implementation, clinical safety or regulatory compliance.
Your photos and files stay on your device, so keep them.
EXAMPLE
Update to an AI medical device software made under an approved predetermined change control plan, with test evidence
1 Nov 2026
Authority time: 14:02 UTC · example
Bitcoin block time: 14:10 UTC · example
Last checked: 15:02 UTC · example
Bitcoin block time: 14:10 UTC · example
Last checked: 15:02 UTC · example
✓ Dated◆ Permanent
Now keep it safe: three things
- Keep your photos and files unedited. The receipt only matches the originals. Put them in an album such as “My records”.
- Save this receipt to your camera roll.
Keep the receipt file too. The image is a handy copy; checking needs the file.
- 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?
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 upWrite 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.
- Write it down straight away, on paper or in the box on a step.
- Put the date, time and place at the top, and who you spoke to.
- Use their words where you can; separate what you saw from what you were told.
- Sign or initial a paper note, photograph it and add the photo.
- 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.
Update to an AI medical device software made under an approved predetermined change control plan, with test evidence
Update to an AI medical device software made under an approved predetermined change control plan, with test evidence
01 · Keep the exact files
Keep the original files for update to an ai medical device software made under an approved predetermined change control plan, with test evidence. Include any existing photos, signed records and source-system exports.
Records to keep: Hash of the update package, test report and plan version
Update to an AI medical device software made under an approved predetermined change control plan, with test evidence
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.
Update to an AI medical device software made under an approved predetermined change control plan, with test evidence
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.
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.
FDA
Authorized PCCP scope
Only changes included in and implemented in accordance with an FDA-authorized PCCP may use its pathway without a new submission for each covered change. A timestamp grants no authorization.
Source summary as of 2026-10-28. Check the current source and applicable local rules.
Read the sourceFDA final guidance
Nonbinding AI device PCCP guidance issued 18 August 2025
Guidance describes modification plans, development and validation methods and impact assessment. A dated package cannot replace required data, implementation or quality records.
Source summary as of 2026-10-28. Check the current source and applicable local rules.
Read the sourceFDA Health Canada and MHRA
Joint PCCP guiding principles
Joint principles support controlled intended changes while noting jurisdictional differences. They do not endorse this product or establish a universal signoff interval.
Source summary as of 2026-10-28. Check the current source and applicable local rules.
Read the sourceOther ways to do this
Prices change. Check each provider’s site for current prices and service details.
Related workflows.
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 establish FDA authorization, successful validation, correct implementation, clinical safety or regulatory compliance.
It does not establish FDA authorization, successful validation, correct implementation, clinical safety or regulatory compliance.
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 an internal change plan count as an authorized PCCP?
No. FDA may authorize a PCCP through the device marketing submission; an internal plan or receipt alone does not do that.
Source summary as of October 30, 2026. Check the current source and its scope.
Context for this answerWhat should the package index cover?
The intended modification, modification protocol and impact assessment, with the associated validation evidence.
Source summary as of October 30, 2026. Check the current source and its scope.
Context for this answerCan every future model update use the same plan?
Only covered modifications implemented in accordance with the authorized PCCP use that pathway.
Source summary as of October 30, 2026. Check the current source and its scope.
Context for this answerDo two signatures prove testing happened?
No. The cited FDA warning described approval records without supporting completed verification and review evidence.
Source summary as of October 30, 2026. Check the current source and its scope.
Context for this answerAre the same PCCP rules global?
No. The joint principles state PCCPs may be developed and implemented differently in different jurisdictions.
Source summary as of October 30, 2026. Check the current source and its scope.
Context for this answerThe 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.