Consensus OS prepares and checks. A qualified person decides and signs. Here is how it works, where it runs, how it is evaluated and what it looks like.
Every use case is the same operation: a reference set, one or more source sets, and a traceable verdict that a person signs.
The questions QA raises in the first meeting, and how the platform is built around them.
No. Qualitum is decision support. Your QMS and document system stay the system of record. Qualitum prepares the work and hands it over for approval.
A qualified person on your side, with an attributable e-signature. Agents prepare and check. They never approve or sign.
Every verdict links to the page and sentence behind it, so a reviewer checks it in seconds. Several models must agree. Where they don’t, the line goes to a person.
Every extraction, check, edit and signature, logged with who, when and which source revision. The audit trail is designed around Annex 11 and 21 CFR Part 11.
Start where the risk is lowest, such as supplier selection, and assess it under your own risk-based approach. We provide the architecture and validation evidence. Documentation
The approach doesn’t depend on it. Human review and sign-off are built into every workflow, so the process holds under today’s rules.
Your documents never leave the environment you control.
A 3-week backtest on a closed evaluation with 3 or more bids and a finished human assessment. No live-decision risk. Success criteria are agreed with you before we start.
From the document workspace to the signed report. Illustrative data from a pharmaceutical equipment project.
Drop in the URS, the vendor quotations, mechanical and functional specs, layouts, alarm lists, P&IDs and signed change orders. Qualitum reads each one, identifies what it is, and makes it addressable at chapter and page level.
| Document | Recognised as | Revision | Pages | Indexed | Used by |
|---|---|---|---|---|---|
| LYO4 - SKAN Isolator - URS Uploaded 12 Jun 2026 · 41 pages | User Requirement Spec | v2.1 | 41 | 247 requirements | Master source |
| CH14.303.A.0239_CO002.pdf | Basic Concept | 26.08.2025 | 24 | Indexed | DQ · 38 refs |
| CH14.303.A.0239_HDS001.pdf | Hardware Design Spec | v1.0 | 52 | Indexed | DQ · IQ · 61 refs |
| CH14.303.A.0239_FS001.pdf | Functional Spec | v1.2 | 88 | Indexed | OQ · 94 refs |
| CH14.303.A.0239_LA002.pdf | Layout drawing | Rev C | 6 | Indexed · OCR | DQ · 12 refs |
| CH14.303.A.0239_AL001.pdf | Alarm list | v1.0 | 19 | Indexed | OQ · 27 refs |
| MS - Mechanical Specification_51906.pdf | Mechanical Spec | v3.0 | 34 | Reading… 68% | - |
| Complete_with_Docusign_Automation_CO.pdf | Signed change order | - | 4 | Indexed | Change control |
Qualitum splits the specification into atomic, testable requirements, assigns a stable ID, and records exactly where each one came from: section, page, and the sentence itself. GxP relevance and criticality are proposed at the same time.
| URS ID | Requirement | Source section | Page | GxP | Criticality |
|---|---|---|---|---|---|
| U3.3-1 v1.0 | Isolator description - Operator will use gloves, which are integrated in the isolator, and tools, which are inside the isolator, to execute tasks in the aseptic core. | 3.3 General Technical Requirements | 5 | No | Informational |
| U3.3-2 v1.0 | Operating modes - the following operating modes must be foreseen: Production · VHP decontamination (aeration included) · Standby. | 3.3 General Technical Requirements | 5 | Yes | Major |
| U3.3-3 v1.0 | Material transfer - pre-sterilised and not pre-sterilised parts can enter and leave the isolator without affecting the decontaminated status of the chamber. | 3.3 General Technical Requirements | 5 | Yes | Critical |
| U3.3-4 v1.0 | General - all cables and optical fibers shall be passed inside the isolator through gas tight bulkheads. The entire working area within the isolator must be cleanable. | 3.3 General Technical Requirements | 6 | Yes | Critical |
| U3.3-5 v1.0 | Air handling system - air during production and aeration: supply air always from surrounding Zone C area and exhaust in the same classified area. | 3.3 General Technical Requirements | 7 | Yes | Major |
| U3.10-22 v1.0 | The system should automatically generate an audit trail for user actions that create or modify electronic records including electronic signatures. | 3.10 ERES Requirements | 27 | Yes | Critical |
| U3.8-05 v1.0 | All rotating or otherwise moving parts should be correspondingly protected during operation against contact by hand - designed in accordance with EN ISO 13857. | 3.8 Health, Safety and Environment | 16 | No | Major |
The detail panel names the root document, the revision, the chapter and the page, and highlights the exact wording in the original PDF beside it. Nothing is paraphrased silently: if the platform rewrote a sentence to make it testable, both versions are shown.
Each requirement is classified for GxP impact, patient risk, data integrity and detectability. Qualitum proposes the classification with its reasoning, the quality lead confirms or overrides it, and the resulting test strategy - which protocols the requirement will appear in - follows automatically.
The traceability matrix runs each requirement against each document in the project and returns the chapters that actually answer it - with chapter number, page and a supporting quote. Where the engine finds several plausible answers, it presents them as candidates rather than guessing.
| URS ID | Requirement | CO002 · Basic Concept | LA002 · Layout | HDS001 · Hardware Design |
|---|---|---|---|---|
| U3.3-1 | Isolator description - operator will use integrated gloves and internal tools to execute tasks in the aseptic core. |
Awaiting selection7 Key features / legend 7 Key features / legend 12 Concept P&ID |
Awaiting selection3 Layout 3 Layout |
Awaiting selection4 Utility supply table |
| U3.3-2 | Operating modes - production, VHP decontamination (aeration included), standby. |
7 Key features / legend 19 · 114 Production mode normal 15 · 704 Conditioning phase 16 · 708 Aeration 1 phase 9.1 |
No relevant chapter | 6 Control philosophy 8.7 |
| U3.3-3 | Material transfer - pre-sterilised and non pre-sterilised parts enter and leave without affecting decontaminated status. |
Awaiting selection11 Leak test & decontamination options 12 Concept P&ID |
Awaiting selection3 Layout 3 Layout |
9 Transfer systems 6.4⚠ |
| U3.3-4 | All cables and optical fibers passed through gas tight bulkheads; entire working area cleanable. |
No relevant chapter | 3 Layout 8.2 |
12 Penetrations & bulkheads 9.3 |
| U3.3-9 | Glove integrity testing must be possible without breaking the decontaminated state. |
No relevant chapter | No relevant chapter | Gap - no evidence Raise design question to vendor |
Each candidate carries its chapter name, chapter number, supporting quote, page and confidence. The reviewer selects, edits or adds a candidate; the decision, the reviewer and the timestamp go to the audit trail. Confidence is never used to auto-approve a critical requirement.
Load two or more supplier quotations and Qualitum answers the only question that matters: for each of your 247 requirements, does this offer meet it - fully, partially, or not at all? Every verdict carries the supplier's own wording and the page it appears on.
| URS ID | Requirement | Source section | Page | Vendor 1 ▾ | Vendor 2 |
|---|---|---|---|---|---|
| U3.8-05 v1.0 | All rotating or otherwise moving parts should be correspondingly protected during operation against contact by hand - designed in accordance with EN ISO 13857. |
3.8 Health, Safety and Environment | 16 | Partial ⚠ "Transparent safety guard, complete machine protection made of aluminium profiles…" 8.0p.6 |
Partial ⚠ "The guarding is built up in aluminium profiles…" 7.1p.4 |
| U3.8-17 v1.0 | All equipment and installations must be designed in such a way that it is possible to use the LOTOTO (Lock-out / Tag-out / Try-out) system during maintenance. |
3.8 Health, Safety and Environment | 18 | Partial "The system includes a 'lockable main switch'…" 8.4p.11 |
Not addressed Not mentioned in the document. |
| U3.3-38 v1.0 | Machine must be designed for manual feeding and removing of the trays. |
3.3 General Technical | 8 | Partial ⚠ "The products are placed crosswise by a…" 6.2p.9 |
Meets "The machine is a stand-alone manually fed…" 9.5p.3 |
| U3.10-22 v1.0 | The system should automatically generate an audit trail for user actions that create or modify electronic records including electronic signatures. |
3.10 ERES Requirements | 27 | Partial "The data to be stored are: machine…" 6.6p.19 |
Not addressed "Software interface TBD" |
Confidence is not decoration. It reflects how directly the source text answers the requirement, whether the wording is verbatim or inferred, and whether other passages in the same document contradict it. Open the score and the platform highlights the passage in the supplier's own PDF.
Validation status is normally a monthly slide built by hand. Here it is a live view: how much of the URS is evidenced, how much is tested, where confidence is thin, what is blocking, and who owns the next action.
| U3.3-9 | No design evidence for glove integrity testing | Vendor question · open 6 d |
| U3.10-22 | Audit trail scope partial in both offers | Clarification CL-014 |
| U3.3-3 | Transfer system match below threshold (6.4) | Awaiting reviewer |
| U3.12-08 | Material certificate not in the document set | Document request |
| OQ-114 | Test step edited after approval - re-signature needed | QA signature |
Every approved requirement produces test steps written against its own acceptance criteria, in your company's protocol format. Each step keeps the URS ID, the design evidence it was derived from, and the reason it exists. Steps with no requirement behind them cannot be created.
| Test ID | Traces to | Test step | Acceptance criteria | Derived from | Status |
|---|---|---|---|---|---|
| OQ-041 | U3.3-2 | Select Production mode at the HMI. Record the mode indicator, differential pressure and air velocity after stabilisation. | Mode indicator reads "Production". Δp ≥ 15 Pa. Air velocity 0.36–0.54 m/s. | CO002 §7 Key features / legend · p.8 HDS001 §6 Control philosophy |
In review |
| OQ-042 | U3.3-2 | Initiate VHP decontamination cycle. Record conditioning, decontamination and aeration phase transitions. | All four phases execute in sequence. H₂O₂ residual < 0.5 ppm at cycle end. | CO002 §15 · 704 Conditioning phase CO002 §16 · 708 Aeration 1 |
In review |
| OQ-114 | U3.10-22 | Create an electronic record as User A. Modify one field. Open the audit trail. | Entry shows user ID, UTC timestamp, previous value and new value. Record is not overwritten. | Risk classification - Critical 21 CFR 11 §11.10(e) |
Approved |
| OQ-115 | U3.10-22 | Attempt to delete an audit trail entry using an administrator account. | Action is refused. Attempt is itself recorded in the audit trail. | Negative test required by criticality rule | Approved |
| OQ-088 | U3.3-4 | Verify all cable and fiber penetrations against the bulkhead schedule; perform a chamber leak test. | Leak rate ≤ 5% of isolator volume at twice operating pressure. | HDS001 §12 Penetrations & bulkheads CO002 §11 Leak test options |
Draft |
Testers record the observed result against the acceptance criteria, attach photographs or instrument printouts, and sign. A failing step raises a deviation on the spot, links it to the requirement, and blocks the protocol from closing until it is resolved or justified.
| Test ID | Acceptance criteria | Observed result | Attachments | Signed | Outcome |
|---|---|---|---|---|---|
| FAT-018 | Δp ≥ 15 Pa in production mode | Δp = 52 Pa, stable over 30 min | Trend export.pdf | J. Meier · 09:41 M. Baškovč · 09:44 | Pass |
| FAT-019 | Air velocity 0.36–0.54 m/s at working height | 0.41 m/s across 9 measurement points | Grid measurement.xlsx 2 photos | J. Meier · 10:12 M. Baškovč · 10:15 | Pass |
| FAT-047 | H₂O₂ residual < 0.5 ppm at cycle end (drying phase excluded) | 0.8 ppm after 4 h aeration; cycle extended to 5 h 20 to reach 0.4 ppm | Sensor log.csv Cycle report.pdf | J. Meier · 14:03 | Deviation DEV-004 |
| FAT-051 | Glove leak test executable without breaking decontaminated state | Not executable - test port not fitted on gloveport 4 | 1 photo | J. Meier · 15:20 | Deviation DEV-005 |
| FAT-052 | Alarm A-114 triggers at Δp < 10 Pa within 5 s | Alarm raised at 3.2 s, logged and acknowledged | Alarm log.pdf | J. Meier · 15:48 M. Baškovč · 15:49 | Pass |
A revised URS clause, a design change, a new supplier revision - Qualitum runs the impact across the whole chain and lists the design evidence, test steps, executed results and signatures affected. Approve the change and the addendum protocol is drafted with only the delta re-tested.
Qualitum records who did what, when, from where, and what the value was before and after - including every action taken by the AI engine, named as such. Signatures carry the signer's printed name, the meaning of the signature and the record it applies to, and cannot be transferred or reused.
| Timestamp (UTC) | Actor | Action | Detail |
|---|---|---|---|
| 22.07.2026 08:14:02 | Qualitum engine AI | Requirement extracted | From URS v2.1 §3.3.2 p.5 · confidence 9.1 · verbatim |
| 22.07.2026 08:14:02 | Qualitum engine AI | Criticality proposed | Major · reasoning stored · model+prompt version recorded |
| 22.07.2026 09:31:47 | M. Baškovč Reviewer | Criticality overridden | Major → Critical · rationale: "affects decontaminated state" |
| 22.07.2026 09:32:10 | M. Baškovč Reviewer | Evidence confirmed | CO002 §7 selected from 4 candidates · 3 rejected |
| 04.07.2026 11:02:55 | A. Kern QA | Protocol approved · e-signature | Meaning: "Approved for execution" · OQ v0.3 |
| 22.07.2026 16:44:19 | System | Signature invalidated | Triggered by CC-2026-018 · re-signature required |
Requirement traceability matrix, DQ report, IQ/OQ/PQ protocols and summary reports, deviation log, vendor comparison and clarification list - generated from the live data in Word, Excel or PDF, in the customer's own templates, with citations preserved as footnotes.
| Deliverable | Format | Template | Last generated | State |
|---|---|---|---|---|
| Requirement Traceability Matrix 247 requirements · 18 documents | Excel · PDF | NVS-QA-TM-04 | 22 Jul · 09:16 | Current |
| Design Qualification Report Includes candidate rationale appendix | Word · PDF/A | NVS-QA-DQ-02 | 18 Jul · 14:02 | Signed |
| OQ Protocol & Summary Report 142 steps · 5 deviations | Word | NVS-QA-OQ-07 | 22 Jul · 16:50 | Regenerate - CC-2026-018 |
| Addendum Protocol - CC-2026-018 Delta only · 9 steps | Word | NVS-QA-AD-01 | - | Ready to draft |
| Vendor comparison & clarifications 2 offers · 31 clarifications | Excel · PDF | Internal | 21 Jul · 11:30 | Current |
| Deviation log 5 open · 12 closed | Excel | NVS-QA-DL-01 | 22 Jul · 17:02 | Current |
| Audit trail extract Full project · 14 812 entries | PDF/A · CSV | - | On demand | Generate |