Category
Feasibility
25% in progress
Prototype
1 in progress
Verification
Qualitative only
복잡하게 얽힌 도메인 프로세스를 분석해 요구사항·설계·검증·운영을 하나의 제품 흐름으로 잇는 기획자 김한들입니다.
제품 기획부터 검증·운영까지, 도메인 중심 B2B 제품을 6년째 만들고 있습니다.
Faithfully mirrors the screen flow and functional structure of the real UI spec (a lab automation system for researchers); all proprietary product names, personal data, and internal document IDs are replaced with fictitious values. Click through a single flow: Home → enter Prototype → select Lab-book → add/open a test → experiment plan → Well information (auto-generated) → select method → data upload → result → acceptance criteria.
25% in progress
1 in progress
Qualitative only
| Lab-book | Revision No. | Updated date | Status | Progress | Note | |
|---|---|---|---|---|---|---|
| Lab-book 2 | 1.0 | 2026-07-28 | In progress | — | ||
| Lab Book_StabilityPanel | 1.0 | 2026-07-28 | On hold | Oligo redesign in progress | ||
| Lab-book 1 | 1.0 | 2026-04-05 | Completed | M&M 13 Selected |
| No. | Test | Status | Progress | Note | |
|---|---|---|---|---|---|
| 1 | 3-1 Bulk product small-scale production stability test (Batch test) | In progress | — | ||
| 2 | Cross-reactivity check | To do | — | ||
| - | 2nd Multi-target selection_sensitivity (Customized test) | To do | — |
The researcher prepares the plate by pipetting by hand, checking each well position visually.
Generate a liquid handler protocol file and dispense with the instrument. The same layout file as Well information is exported automatically.
| File name | PCR raw data | Well information | PCR instrument | Note | ★ | ||
|---|---|---|---|---|---|---|---|
| admin_2026-07-23_14-25_BR205025_plate1 | Nobaseline ✕ | Baseline ✓ | Well information 1 / Plate 1 | CFX96 | Retest | ||
| admin_2026-07-23_14-26_BR205030_plate2 | Nobaseline ✓ | Baseline ✓ | Well information 1 / Plate 2 | CFX96 | — | ||
| Well | Fluorophore | Analyte | Ct | Melt Tm | Result |
|---|---|---|---|---|---|
| A1 | FAM | Analyte 1 | 24.3 | 82.1 | Positive |
| A2 | HEX | Analyte 2 | 26.7 | 79.4 | Positive |
| A3 | Cal Red 610 | Analyte 3 | - | - | Negative |
| A4 | Quasar 670 | IC | 29.5 | - | Valid |
| Fluorophore | Analyte | Template pDNA |
Ct | Melt peak height | Melt Tm | Ct Pass Criteria | History | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Min | Max | Average | Min | Max | Average | Min | Max | Average | Ct Max | ||||
| FAM_L | Analyte 1 | Template 1 | 23.1 | 25.4 | 24.2 | 410 | 480 | 446 | 81.9 | 82.6 | 82.2 | 30.0 | — |
| FAM_H | Analyte 2 | Template 2 | 25.9 | 27.8 | 26.9 | 390 | 455 | 420 | 79.0 | 79.8 | 79.4 | 32.0 | — |
| HEX_L | Analyte 3 | Template 3 | — | — | — | — | — | — | — | — | — | 33.0 | — |
| HEX_H | Analyte 4 | Template 4 | 28.0 | 30.5 | 29.4 | 360 | 410 | 388 | 84.1 | 84.9 | 84.5 | 35.0 | — |
| Quasar 670_L | IC | — | 27.2 | 29.0 | 28.1 | 300 | 360 | 330 | — | — | — | 32.0 | — |
| Product Category | ID | Item Name | Disease Category | Product | Regulatory Body | Purpose | Status | Created Date | ||
|---|---|---|---|---|---|---|---|---|---|---|
| Panel A | 5736 | Add PCR instrument support - Panel A Detection | Human Papillomavirus | Panel A Detection | CE-IVDR | Product maintenance | - | 2026-08-28 | ||
| Panel B | 5728 | Target oligo update - Panel B Master Assay | Respiratory Infection | Panel B Master Assay | CE-IVDD +4 | Product maintenance | Ready | 2026-08-26 | ||
| Panel B | 5727 | Add PCR instrument support - Panel B Master Assay | Respiratory Infection | Panel B Master Assay | CE-IVDR | Product maintenance | Ready | 2026-08-26 | ||
| Panel C | 5704 | Probe change - Panel C Assay | Gastrointestinal Infection | Panel C Assay | CE-IVDR | Product renewal | - | 2026-08-07 | ||
| Panel A | 5673 | Dummy project 12222 | Urinary Tract Infection | - | - | New product development | - | 2026-07-03 |
| Name | Organization | Process Authority | ||
|---|---|---|---|---|
| Haneul Lee | hnlee_1@labworks.io | Strategy Planning Team 2 |
There are no Exp Groups.
| No. | Stage | Experiment name | Condition repeats per experiment | |||||
|---|---|---|---|---|---|---|---|---|
| Template | Negative Sample | NC | PC | |||||
| ⠿ | 1 | Feasibility | Test A | |||||
| ⠿ | 2 | Feasibility | Test B | |||||
| ⠿ | 3 | Feasibility | Test C | |||||
| ⠿ | 4 | Verification | Test D | |||||
| ⠿ | 5 | Verification | Test E | |||||
| ⠿ | 6 | Verification | Test F | |||||
| Type | Analyte | Template | Channel · Temp. | Preparation method | Vendor | Isolate/Strain No. | |
|---|---|---|---|---|---|---|---|
| pDNA | PA66 | PA66_3306 | FAM · Low | 10⁸ Dilution NS Spiking | Korean isolate | - | |
| pDNA | PA45 | PA45_3403 | FAM · Mid | 10⁸ Dilution NS Spiking | NIBSC | 14/104 | |
| pDNA | PA58 | PA58_3366 | FAM · High | 10⁸ Dilution NS Spiking | NIBSC | 14/264 | |
| pDNA | PA51 | PA51_3642 | HEX · Low | 10⁸ Dilution NS Spiking | Korean isolate | - | |
| pDNA | PA59 | PA59_3427 | HEX · Mid | 10⁸ Dilution NS Spiking | Korean isolate | - | |
| Strain | PA16 | Ref. Strain A | HEX · High | NS Spiking | CellBank Korea | 30035 |
| Template | Status | Stock Conc. | Spiking factor | Final volume (µL) | Final conc. (1×LoD) | |
|---|---|---|---|---|---|---|
| PA66_3306 | Not calculated | /mL | 3,941 copies/mL | |||
| PA45_3403 | Not calculated | /mL | 5,643 IU/mL | |||
| PA58_3366 | Not calculated | /mL | 2,263 IU/mL | |||
| Template | Concentration | Test A combination | IC spiking | Consumption by experiment | Total |
|---|---|---|---|---|---|
| Stock PA26 | 10⁸ copies/rxn | - | - | Used after dilution · no direct consumption | - |
| Stock PA66 | 10⁸ copies/rxn | - | - | Used after dilution · no direct consumption | - |
| Stock PA45 | 10⁸ copies/rxn | - | - | Used after dilution · no direct consumption | - |
| Stock PA69 | 10⁸ copies/rxn | - | - | Used after dilution · no direct consumption | - |
| Stock PA58 | 10⁸ copies/rxn | - | - | Used after dilution · no direct consumption | - |
25% in progress
Not covered
Qualitative only
| Lab-book | Revision No. | Updated date | Status | Progress | Note | |
|---|---|---|---|---|---|---|
| Lab-book 1 | 1.0 | 2026-04-05 | Completed | M&M 13 Selected | ||
| Lab Book_StabilityPanel | 1.0 | 2026-07-28 | On hold | Oligo redesign in progress | ||
| Lab-book 2 | 1.0 | 2026-07-28 | In progress | — |
| No. | Test | Status | Progress | Note | |
|---|---|---|---|---|---|
| 1 | 3-1 Bulk product small-scale production stability test (Batch test) | In progress |
Plan 100% Exp. 40% Result 0% Disc. 0% |
— | |
| 2 | Cross-reactivity check | To do |
Plan 0% Exp. 0% Result 0% Disc. 0% |
— |
Template dilution / manufacturing — done manually
Mastermix/Template dispensing — manual or automation
The researcher prepares the plate by pipetting by hand, checking each well position visually.
Generate a liquid handler protocol file and dispense with the instrument. The same layout file as Well information is exported automatically.
| File name | PCR raw data | Well information | PCR instrument | Note | ★ | ||
|---|---|---|---|---|---|---|---|
| admin_2026-07-23_14-25_BR205025_plate1 | Nobaseline ✕ | Baseline ✓ | Well information 1 / Plate 1 | CFX96 | Retest | ||
| admin_2026-07-23_14-26_BR205030_plate2 | Nobaseline ✓ | Baseline ✓ | Well information 1 / Plate 2 | CFX96 | — | ||
| Well | Fluorophore | Analyte | Ct | Melt Tm | Result |
|---|---|---|---|---|---|
| A1 | FAM | Analyte 1 | 24.3 | 82.1 | Positive |
| A2 | HEX | Analyte 2 | 26.7 | 79.4 | Positive |
| A3 | Cal Red 610 | Analyte 3 | - | - | Negative |
| A4 | Quasar 670 | IC | 29.5 | - | Valid |
| Product | Regulatory | Last Run | Experiments | Handoff Status | DMR | |
|---|---|---|---|---|---|---|
| Panel D Panel D Multiplex (EU) | CE-IVDR | 2026-08-28 | 17 | DMR in progress | › | |
| Panel A Panel A Detection | CE-IVDR | 2026-08-20 | 12 | Handed off | › | |
| Panel B Panel B Master Assay | CE-IVDD | 2026-08-14 | 9 | Not started | › |
| Product Size (rxn/kit) | Cat No. | Product Proper Number (4 char) | Item Code (5 char) | Barcode | C/D (1 char) | UDI Barcode | Expiry Date | Storage Temp. | |
|---|---|---|---|---|---|---|---|---|---|
| 100rxn | CAT-6600X | PAND | - | - | C | - | - | - | |
| 100rxn | CAT-6600X | - | - | - | - | - | - | - | |
| 50rxn | CAT-6600Y | - | - | - | - | - | - | - |
| In-process Product Type | In-process Product Name | Cat No. | Remarks | |
|---|---|---|---|---|
| MOM | CAT-6600Y | - | ||
| - | - | - | ||
| - | - | (Additional experiment) IC(NC) test, 72h Aging test |
| In-process Product Name | Vol. (μL) | |
|---|---|---|
| EM5 | 5 | |
| EM5 Buffer | 5 | |
| ABC MOM | 5 | |
| Template | 5 | |
| Total | 20 |
| Step | No. of Cycles | Temperature | Duration | Plate Read | |
|---|---|---|---|---|---|
| 1 | 1 | - | - | - | |
| 2 | GO TO Step 1, Wrap Around: 1 more times | - | - | - | |
| 3 | Temp. Range: 60 ~ 90 ℃ (s/℃) | - | - | - |
| Channel | Analyte | pDNA | Melt Criteria Min Peak height | Min Tm(℃) | Max Tm(℃) | Concentration 1 (Ct / RFU / Peak height) | Test | ||
|---|---|---|---|---|---|---|---|---|---|
| FAM_L | Target A_groL | Test 1 | |||||||
| FAM_H | Target A_groL | Test 2 | |||||||
| HEX_L | Target B_grp1 | Test 3 | |||||||
| HEX_H | Target B_grp1 | Test 4 | |||||||
| Cal Red 610_L | Target C_scr | Test 5 | |||||||
| Ch5_L | - | Test 9 | |||||||
| Ch6_H | - | Test 6 | |||||||
| Analyte | Acceptance Rule | Applied | |
|---|---|---|---|
| Target A | Ct ≤ 35.0 and RFU ≥ 500 | Yes | |
| Target B | Ct ≤ 35.0 and RFU ≥ 500 | Yes | |
| Target C | Ct ≤ 35.0 and RFU ≥ 500 | No | |
| IC | Ct ≤ 32.0 | Yes |
| Analyte | Ct Min | Ct Max | RFU Min | Melt Tm Min(℃) | Melt Tm Max(℃) | |
|---|---|---|---|---|---|---|
| Target A | 🗑 | |||||
| Target B | 🗑 | |||||
| Target C | 🗑 | |||||
| IC | 🗑 |