Controlled document · Baseline diff
SRS v1.1 → SRS v1.2
Lucora RM · Baseline Diff
What changed between SRS v1.1 and SRS v1.2
Continuous Glucose Monitor, Generation 2 · controlled comparison report
From
SRS v1.1
Approved 2026-01-19 10:11 UTC
Approver: Dr. Mei Lin
Items: 198 · Links: 462
Hash: a3c1…7e22
To
SRS v1.2
Approved 2026-03-27 14:02 UTC
Approver: Dr. Mei Lin
Items: 210 · Links: 498
Hash: e3b0…b855
This report enumerates every change to items, trace links, statuses, and identifiers between two approved baselines. It is generated from the immutable audit log; for each change, the author, timestamp, and content hash are preserved and verifiable. Use this report alongside the audit export package for design-control review submissions or notified-body inspections.
End of §1 · continues
§2Change Summary
Items added
+12
across 5 types
Items removed
−2
explicit deprecations
Items modified
14
8 substantive
Status changes
23
19 → approved
By artifact type
| # | Type |
In v1.1 | In v1.2 |
Added |
Removed |
Modified |
Status Δ |
Coupling impact
The new Cloud Sync subsystem (4 items added) introduces 11 outbound trace links into existing items. Sensor FW remains the most highly coupled subsystem (47 internal + 18 external links).
End of §2
§3Items Added
Twelve new items appear in v1.2 that were not part of v1.1. Each is shown with its initial author and the trace links established at creation.
| # |
Type |
ID |
Title |
Author |
Created |
Status |
End of §3
§4Items Removed
Two items present in v1.1 are no longer part of v1.2. Removal of an approved item requires a Part 11 justification (captured below) and updates downstream trace coverage.
| # |
Type |
ID |
Title |
Removed by |
Justification |
End of §4
§5Items Modified
Field-level diffs for items whose substantive content changed between baselines. Trivial copy-edits (whitespace, capitalization) are aggregated at the bottom and not shown individually.
End of §5
§6Status & Approval Changes
Items whose lifecycle status transitioned between baselines. Approvals are bound to Part 11 e-signatures (see §9).
| # |
Type |
ID |
Title |
From → To |
Approver |
Timestamp |
End of §6
§7Trace Link Changes
Trace edges added, removed, or whose link-type changed. Coverage gaps closed during this baseline window are flagged.
7.1 Links added
7.2 Links removed
7.3 Coverage impact
Coverage closed
+4
requirements newly verified
Coverage opened
1
previously verified, now lacking V&V
End of §7
§8Renumbered Items
Identifier changes are highly controlled (§4.7). Each renumbering carries a separate signed justification and is preserved in the item's display_id_history. Redirects ensure prior references continue to resolve.
| # |
Type |
Old ID |
New ID |
Reason |
Authorized by |
Timestamp |
End of §8
§9Signature Trail
Part 11 electronic signatures captured during the v1.1 → v1.2 window. Signatures bind a signer's authenticated identity, server-attested timestamp, content hash, and meaning of signature.
| # |
Signer |
Role |
Meaning |
Scope |
Timestamp (UTC) |
Hash |