Regulatory compliance

What qTrace covers —
and what it doesn't

qTrace is a provenance and audit-trail layer for digital pathology analysis in QuPath. Each section below maps our features to specific regulatory articles, and clearly states what remains with your laboratory's LIS, QMS, or IT infrastructure.

ISO 15189:202221 CFR Part 11GLP / ALCOA+IVDR 2017/746ICH E6 GCP

How integrity works today

The mappings below rely on these four mechanisms. Each one applies only under the condition shown.

Recorded

Core

Every QuPath workflow step is written to a .qtrace JSON file next to the image, with the contributor and a workstation timestamp.

Signed

Compliance licence

Validate & Stamp signs the stamp with the validator’s Ed25519 key, unlocked by a passphrase. The name comes from the KYC-verified licence.

Checked

Compliance licence

After a stamp, any change to the stamped session, the .qpdata or satellite files is detected — in QuPath and with the open-source qtrace-verify tool.

Anchored

Cloud Workspace Push

Pushed certificates are timestamped with OpenTimestamps on Bitcoin — independent proof that the record existed at that time.

Current limits

  • Sessions that are not stamped are recorded but not tamper-evident.
  • Timestamps come from the workstation clock until a certificate is anchored.
  • Changes are detected, not prevented: .qtrace files are ordinary files on your disk.
  • The signing passphrase is asked once per QuPath session, not at every signature.
  • qTrace is not a validated system and not a medical device.

ISO 15189:2022 + A11:2023

Partial support

ISO/TC 212 · EN ISO 15189:2022 + A11:2023 (eCEN/EVS)

Medical laboratories — Requirements for quality and competence. qTrace records the digital pathology analysis performed in QuPath (part of the examination process, §7.3) and provides evidence for the documentation and traceability obligations below. It does not make a laboratory ISO 15189 compliant.

✓ What qTrace covers

  • §7.3.1 d)Operator recorded per session. With a Compliance licence, the validator name comes from the KYC-verified licence and cannot be edited in the stamp dialog; without one, the name is self-declared
  • §7.3.6Analysis steps recorded and exported as a Groovy replay script (MetaScript)
  • §7.3.2Replay of a recorded workflow on the same or another image (Player module, installed with Core) — supports reproducibility checks; comparing results remains with the lab
  • §7.4.1.8New sessions are appended to the .qtrace; after a stamp, any later change to the stamped session, its .qpdata or satellite files is detected and flagged
  • §7.5Manual detection and annotation corrections recorded with operator and timestamp (Dashboard Card 7); a justification can be entered but is optional today
  • §7.6.3Integrity of validated sessions — Ed25519 signature over the stamp, SHA-256 of the image and .qpdata. Changes after stamping are detected, not prevented
  • §8.4.1Records created at the time of each act — ActionLogger listens to QuPath’s workflow events in real time
  • §8.4.2–3Records kept as open JSON next to the image; optional off-site copy of certified cases via Cloud Workspace Push
  • §8.8Dashboard indicators (Cards 1–7) available as input to management review (§8.9)

⬜ Remains with your laboratory

  • §7.2Pre-analytical processes (sample collection, transport) — handled by your LIS/LIMS
  • §6.5Equipment calibration and metrological traceability — physical instruments, out of scope
  • §7.3.4Measurement uncertainty (MU) evaluation — laboratory's statistical responsibility
  • §7.3.7.2Internal Quality Control (IQC) programmes — dedicated QC software required
  • §6.2Personnel competence records and training programmes — your HR/QMS
  • §8.4Access control, backup and retention of record files — .qtrace files live on your workstation or share; permissions and archiving remain with your IT
  • §8.8.3Internal audit programme — qTrace provides the data, audits remain with the lab

In short: qTrace provides records and signed evidence for the QuPath analysis part of the examination process. Accreditation, access control and retention remain with the laboratory.

Sources

  • —EN ISO 15189:2022 — Medical laboratories: Requirements for quality and competence · ISO/TC 212, published via EVS/eCEN
  • —A11:2023 — Amendment 1 to ISO 15189:2022 · corrigendum, published 2023

21 CFR Part 11

Partial support

FDA · 21 CFR Part 11 — Electronic Records; Electronic Signatures (eCFR, up to date 25 June 2026)

Sets criteria under which the FDA considers electronic records and signatures trustworthy and equivalent to paper. qTrace provides record and electronic-signature building blocks for QuPath analysis records. It is not a validated system and does not by itself make an installation Part 11 compliant.

✓ What qTrace covers

  • §11.10(e)Computer-generated, time-stamped record of each QuPath workflow step (ActionLogger). Timestamps come from the workstation clock; stamped sessions are protected by signature, unstamped sessions are not
  • §11.10(b)Human-readable and electronic copies — .qtrace JSON, PDF certificate, batch ZIP export
  • §11.50(a)Signature manifestation: printed name (from the KYC-verified licence), date-time (ISO 8601 UTC) and meaning of the signature — all inside the signed bytes
  • §11.70Signature linked to its record — the Ed25519 signature covers the stamp and the SHA-256 of the image and .qpdata; the .qtcert certificate covers the stamped session. Any edit fails verification
  • §11.100(b)Signer identity verified (Stripe Identity KYC) before a Compliance licence and signing key are issued
  • §11.200(a)Two components: the licence and the passphrase that unlocks the private signing key. The passphrase is requested once per QuPath session, not at every signing

⬜ Remains with your laboratory

  • §11.10(a)System validation (IQ/OQ/PQ) of the full installation — no vendor validation package is provided today
  • §11.10(d)Limiting system access to authorised individuals — record files are local; access control is provided by your OS and IT
  • §11.10(f)(h)Operational system checks and device checks — IT infrastructure responsibility
  • §11.10(i)(j)Personnel training documentation and written accountability policies — your QMS
  • §11.100(c)FDA Letter of Non-Repudiation Agreement — organisational obligation, not a software feature
  • §11.200(a)(1)Re-entry of signature components for later signings in the same session — your SOP should require restarting QuPath or locking the workstation between signers
  • §11.300ID/password management controls (rotation, loss management) — your IT department

In short: qTrace provides electronic-record and electronic-signature building blocks (signed stamps, KYC-verified signer, signature manifestation). System validation, access control and signing procedures remain with the laboratory.

Sources

  • —21 CFR Part 11 — Electronic Records; Electronic Signatures · eCFR Title 21, Chapter I, Subchapter A, up to date 25 June 2026

GLP / ALCOA+

Partial support

FDA CGMP Data Integrity Guidance (Dec 2018) · MHRA GxP Data Integrity Guidance (Mar 2018) · PIC/S PI 041-1 (Jul 2021) · OECD GLP ENV/MC/CHEM(98)17 · WHO TRS 996 Annex 5 (2016)

ALCOA+ defines nine attributes any laboratory data record must satisfy to be considered reliable by regulatory authorities (FDA, EMA, MHRA, ANVISA). It is a principle-based framework applied across GLP, GMP, and GCP — not a single regulation. qTrace contributes to each attribute for analysis records produced in QuPath; the list below states how, and where the limits are.

✓ What qTrace covers

  • AttributableEach session records a contributor. With a Compliance licence, the validator is KYC-verified and bound to the stamp by an Ed25519 signature; without one, the name is self-declared (OS login as fallback)
  • LegiblePlain-text JSON, readable in any text editor without qTrace
  • ContemporaneousActionLogger records each QuPath workflow step as it happens, with workstation timestamps
  • OriginalSessions are appended to the .qtrace rather than rewritten; for stamped sessions, the signed certificate preserves what was validated and any later divergence is flagged
  • AccurateCaptured directly from QuPath, no manual transcription; manual corrections recorded separately with operator and timestamp
  • Complete (+)Workflow steps, classifier changes (with SHA-256), annotations, extension list and parameters. Interactive-only tools (e.g. SAM) and some extensions are only partially captured — see the extension catalogue
  • Consistent (+)Versioned JSON schema, ISO 8601 UTC timestamps, identical format on every machine
  • Enduring (+)Open JSON format with no qTrace dependency, stored next to the image; optional off-site copy via Cloud Workspace Push; exit bundle verifiable without qtrace.ca
  • Available (+)Dashboard filters by project, contributor and status; batch ZIP export; files readable without qTrace installed

⬜ Remains with your laboratory

  • Wet lab dataPCR, spectrophotometry, centrifugation records, paper lab notebooks — your ELN/LIMS; ALCOA+ applies to all lab data, not only digital analysis
  • SOPs / DMSWritten procedures and work instructions must themselves be managed in an ALCOA+-compliant document management system (QMS/DMS)
  • TrainingPersonnel competence and qualification records — regulated ALCOA+ data, belongs in your HR/QMS system
  • Scanner / WSIRaw whole-slide images and scanner acquisition metadata (calibration, lighting, scan parameters) — scanner vendor and imaging archive responsibility
  • RetentionBackup, archiving and retention periods for .qtrace files — your archiving policy; qTrace does not guarantee a retention period
  • CSV / GAMP 5Computer System Validation of the full installation (workstation, OS, network, QuPath) per OECD GLP Consensus Doc n°17 / GAMP 5 — laboratory obligation

In short: qTrace contributes to each ALCOA+ attribute for QuPath analysis records, with the limits stated above.

Sources

  • —FDA — Data Integrity and Compliance With Drug CGMP · Guidance for Industry, December 2018
  • —MHRA — GxP Data Integrity Guidance and Definitions · Revision 1, March 2018

IVDR 2017/746

Partial support

EU Regulation 2017/746 · Official Journal L 117, 5.5.2017 — on in vitro diagnostic medical devices (CELEX:32017R0746)

IVDR regulates IVD device manufacturers and health institutions that make and use devices in-house. qTrace is not a medical device and is not CE-marked. For labs using QuPath in this context, qTrace records how each analysis was run — material that can feed the documentation below. It does not establish compliance or eligibility on its own.

✓ What qTrace covers

  • Art. 5(5)Health institution exemption — among its conditions are an appropriate QMS and ISO 15189 compliance; qTrace records can serve as evidence for the QuPath analysis part
  • Art. 10(3)Performance evaluation (Annex XIII) — .qtrace sessions document how each analysis was run
  • Art. 10(4)Technical documentation input — software version, classifier SHA-256 and parameters recorded per session
  • Art. 68(3)Performance study data — analysis steps recorded as they happen with the operator; stamped sessions are signed and verifiable
  • Art. 73(5)Performance study report — batch export and replay script document the analysis method
  • Art. 78Post-market surveillance — accumulated .qtrace sessions can serve as a real-world dataset for PMS reports

⬜ Remains with your laboratory

  • Art. 10(7)Record retention periods — your archiving policy; qTrace does not guarantee retention
  • Art. 10(8)Quality management system — qTrace records can feed it; the QMS itself remains with the manufacturer or institution
  • Art. 17–18EU Declaration of Conformity and CE marking — manufacturer obligations; not a software feature
  • Art. 24–26UDI assignment and Eudamed registration — manufacturer obligations
  • Art. 29Summary of Safety and Performance (class C/D devices) — document authored by the manufacturer
  • Art. 48Conformity assessment by Notified Body — third-party certification process
  • Art. 56Performance evaluation plan and clinical evidence generation — statistical analysis and regulatory authoring remain with the manufacturer
  • Art. 59Informed consent and subject personal data management — sponsor/lab obligation under GDPR

In short: qTrace is not a medical device. It records how QuPath analyses were run, which can feed IVDR documentation prepared by the manufacturer or health institution.

Sources

  • —Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 · OJ L 117, 5.5.2017, CELEX:32017R0746 — official text read from docs/Normes/

ICH E6(R3) GCP

Partial support

ICH Harmonised Guideline E6(R3) — Good Clinical Practice · Step 4, 06 January 2025 · database.ich.org

ICH E6(R3) is the global standard for Good Clinical Practice in clinical trials. The R3 revision (January 2025) strengthens requirements for data integrity, audit trails, and computerised systems governance (§4 Data Governance). qTrace records the QuPath image-analysis part of trial data; it is not a validated computerised system on its own.

✓ What qTrace covers

  • Princ. 9.4Record traceability for QuPath image analysis — who did what, when, with which parameters
  • §3.16.1(e)Capture → .qtrace → signed certificate → optional Cloud Push, for the QuPath analysis part of the data life cycle
  • §3.16.1(i–j)Manual corrections recorded with operator and timestamp; a justification can be entered (optional today)
  • §3.16.1(l)Stamped certificates carry an Ed25519 signature anyone can verify; pushed certificates are also anchored with OpenTimestamps (Bitcoin), so later tampering is detectable without trusting qTrace
  • §3.16.4(a)Direct access for monitors and auditors — plain-text JSON, batch ZIP export, shareable verification page
  • §4.2.1(b)Data captured with metadata — operator, timestamp, QuPath version, extension list, classifier SHA-256 and parameters alongside each workflow step
  • §4.2.2(a)(ii–iii)Workflow actions recorded as they happen, with ISO 8601 UTC timestamps from the workstation clock
  • §4.2.4Corrections attributed to the operator, original detections kept in the record; justification optional today

⬜ Remains with your laboratory

  • §2.12Investigator source records for trial participants (medical records, case report forms, adverse event logs) — clinical participant records outside the QuPath analysis workflow
  • §4.2.2(a)(i)User access logs — qTrace does not log logins to the workstation or to QuPath
  • §4.2.2(b)Protection of the audit trail from being disabled or modified — .qtrace files are local and unstamped sessions are not tamper-evident; file access control remains with your IT
  • §3.16.3 / §4.2.7Retention and protection over the full retention period, backup and disaster recovery (§4.3.3) — your archiving policy
  • §4.1Blinding safeguards in data governance (randomisation codes, treatment unblinding procedures) — not applicable to pathological image analysis workflows
  • §4.3.2 / 4.3.4Personnel training on computerised systems + full system validation (IQ/OQ/PQ, CSV per GAMP 5) — laboratory and sponsor obligations
  • §3.16.2Statistical programming, analysis plan QC, and traceability of data transformations for final analysis — sponsor/biostatistician obligation
  • §3.13Safety assessment, adverse event reporting, and SUSAR pharmacovigilance — sponsor obligation
  • §1 / §2.8IRB/IEC submissions, ethical approvals, and informed consent procedures — institutional and sponsor/investigator obligations

In short: qTrace records the QuPath image-analysis part of trial data. Access logging, audit-trail protection, retention and system validation remain with the investigator/sponsor.

Sources

  • —ICH E6(R3) — Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice · Step 4, adopted 06 January 2025 — database.ich.org

qTrace is a compliance tool, not a compliance programme

No single software product can make a laboratory fully compliant with any of these regulations. Compliance requires a combination of validated tools, qualified personnel, written procedures, and organisational governance. qTrace contributes records and signed evidence for the QuPath analysis part of that effort; it is not itself a validated system, and it is not a medical device.