Custodyn — Platform Walkthrough

VISCHARI SOLUTIONS × INLABCO

Custodyn · 01 / 20

Overview

Custodyn — the Electronic Logbook for regulated labs

Domain Expertise by Inlabco · Built by Vischari Solutions

Custodyn Platform

One auditable chain that traces the asset, the environment, and the sample — pre-mapped to Indian and global compliance, built to work where LIMS can't: in the cold room and inside the LN₂ tank.

✓ Equipment Digital Twin

✓ Compliance-as-Config

✓ Inspection Mode & Audit Replay

✓ Excursion-to-CAPA automation

✓ Offline-first capture

✓ Biobank & IVF verticals

Domain by Inlabco

Built by Vischari Solutions

09 June 2026

Version 1.0

20 Slides

~25 minute walkthrough

VISCHARI SOLUTIONS × INLABCO

Custodyn · 02 / 20

The Problem

Where LIMS stops working

The blind spots in today's lab record

Audit risk

❄️

The cold room & LN₂ tank

LIMS assumes a desk and a browser. Witnessing and logging break down at −80 °C and inside liquid nitrogen — exactly where the high-value samples live.

📋

Paper logbooks

Calibration, PM, breakdown and usage still live in Word forms and binders. No live qualification status, no replayable trail.

🔌

Disconnected systems

Equipment, environment and sample data sit in three systems. Reconstructing a chain of custody for an auditor takes days.

⏱️

Excursions caught late

A freezer breach is found at the next manual check. Impact assessment and CAPA start from scratch, often days later.

RI Witness and Matcher witness in the lab, but not through vitrification, storage and thawing inside LN₂. That gap is documented — and unaddressed.

VISCHARI SOLUTIONS × INLABCO

Custodyn · 03 / 20

Positioning

One auditable chain: asset · environment · sample

🧬

The Asset

Every freezer, incubator and tank carries a Digital Twin: IQ/OQ/PQ, calibration, PM, breakdown, AMC, retirement.

🌡️

The Environment

Temperature, LN₂ level and conditions mapped continuously — from room to rack to box to position.

🧪

The Sample

Each aliquot carries its full thermal history, consent state and integrity score, from collection to release.

⬇️ linked in one timeline ⬇️

One replayable audit trail

Pre-mapped to 21 CFR Part 11, EU Annex 11, NABL, CAP, NABH, ICMR, ISO 20387 / 15189 and ART Act 2021.

VISCHARI SOLUTIONS × INLABCO

Custodyn · 04 / 20

Architecture

One core platform, two specialised verticals

Core Platform · horizontal

🧬

Equipment Digital Twin

⚙️

Compliance-as-Config

🛡️

Inspection / Audit Replay

🔁

Excursion-to-CAPA

📱

Offline-first Capture

📝

Logbook Builder

Custodyn Biobank

3D thermal mapping, Sample Thermal Passport, Integrity Score, consent lifecycle, LN₂ & cryo-position tracking.

Custodyn IVF

Cryo-native electronic witnessing, media & consumable batch witnessing, end-to-end ART chain, ART Act 2021 pack.

VISCHARI SOLUTIONS × INLABCO

Custodyn · 05 / 20

Auth

Secure login with compliant e-signature

Sign in to Custodyn

Email Password

Two-factor required for QA, Manager and Auditor roles. Every signed action re-prompts for the meaning of the signature.

VISCHARI SOLUTIONS × INLABCO

Custodyn · 06 / 20

Permissions

Four roles, one permission model

Role × capability

System-enforced

Role	Log entries	E-sign / review	Config regime	Approve CAPA	Release samples	Audit replay
Lab Technician / Operator	✓	—	—	—	—	—
QA / Compliance Officer	✓	✓	✓	✓	—	✓
Lab Manager / Biobank Director	✓	✓	—	✓	✓	✓
Auditor / Read-only Inspector	—	—	—	—	—	✓

Mandatory rules (audit-trail capture, e-sign on signed steps, withdrawal cascade, deletion via approval) cannot be toggled off by any role.

VISCHARI SOLUTIONS × INLABCO

Custodyn · 07 / 20

Equipment

Equipment Digital Twin — one timeline per asset

FRZ-08 · ULT −80 °C Freezer · Thermo TSX

Qualified · PQ valid to 14/11/26

01

Procurement

12/01/24

02

Installation

03/02/24

03

IQ

05/02/24

04

OQ

08/02/24

05

PQ

14/02/24

06

Released

15/02/24

07

Calibration

14/05/26

08

PM

20/05/26

09

Breakdown

02/06/26

10

AMC repair

04/06/26

11

Re-qualification

in progress

12

Retirement

pending

Linked records: 3 calibration certs · 6 PM logs · 1 breakdown report · 412 environmental readings · 1,840 samples currently held.

VISCHARI SOLUTIONS × INLABCO

Custodyn · 08 / 20

Compliance

Compliance-as-Config — toggle a regime, rules enforce

Regulatory regimes

Pre-validated profiles

Regime	E-signature	Audit trail	Second review	Status
21 CFR Part 11	Required	Immutable	On signed steps	On
EU Annex 11	Required	Immutable	On signed steps	On
NABL / ISO 15189	Required	Immutable	Configurable	On
ISO 20387 (biobank)	Required	Immutable	Configurable	Available
CAP / NABH	Required	Immutable	On release	Available
ICMR · ART Act 2021	Required	Immutable	On distribution	Available

Switching a regime on reconfigures e-sign prompts, audit-trail depth and review gates across the whole platform — no custom development.

VISCHARI SOLUTIONS × INLABCO

Custodyn · 09 / 20

Dashboard

Live operations dashboard

Site overview · Kochi facility

Last refresh: 2 min

Qualified Assets

318

of 342 total

Open Excursions

4

2 critical

CAPAs in progress

7

1 overdue

Calibrations due 30d

12

3 this week

Qualification compliance · last 12 weeks

Asset status mix

VISCHARI SOLUTIONS × INLABCO

Custodyn · 10 / 20

Audit

Inspection Mode & Audit Replay

Replay · Sample BBK-2241-A3

Time-travel to12 Apr 2026 ▾

Timestamp	Event	Asset / location	By	Signed
02 Feb 26 · 09:14	Collected & accessioned	Reception	A. Pillai	✓
02 Feb 26 · 11:40	Stored → Box 14, Pos A3	FRZ-08 · Shelf 2 · Rack 5	A. Pillai	✓
14 Mar 26 · 03:22	Excursion −68 °C for 41 min	FRZ-08	System	—
14 Mar 26 · 09:05	Impact assessed · no compromise	FRZ-08	R. Menon (QA)	✓
12 Apr 26 · 16:18	Retrieved for aliquoting	FRZ-08 → BSC-02	S. Nair	✓
12 Apr 26 · 16:51	Returned → Box 14, Pos A3	FRZ-08	S. Nair	✓

Reconstructs the full state of any asset, area or sample as it was on the selected date — one click, nothing to assemble by hand.

VISCHARI SOLUTIONS × INLABCO

Custodyn · 11 / 20

Change Control

Excursion-to-CAPA automation

Deviation DEV-2026-038 · auto-opened

Critical

Cold-chain breach · FRZ-03 (LN₂ vapour)

Trigger: −150 °C for 23 min · 04 Jun 26, 02:11 · 96 samples in scope

Auto-attached: thermal history (±6 h), affected sample list, asset qualification state.

Step 1

Deviation opened

Automatic · 02:11

Step 2

Impact assessment

QA · proposed disposition

Step 3

CAPA-2026-019

Open · due 18 Jun

Step 4

Closure & sign-off

pending

VISCHARI SOLUTIONS × INLABCO

Custodyn · 12 / 20

Mobile

Offline-first capture for cold rooms & LN₂ areas

Cold Room A · Log

Offline

Scan asset / sample

FRZ-08 · Box 14 · Pos A3

Temp

−79 °C

LN₂ level

68%

3 entries queued · sync when back online. Timestamps preserved.

VISCHARI SOLUTIONS × INLABCO

Custodyn · 13 / 20

No-code

Logbook Builder — your SOP forms, digitised

Build logbook · Freezer Daily Temperature Log

From SOP-EQ-014.docx

Field label

Field type

Acceptable range

On out-of-range

Signing rule

VISCHARI SOLUTIONS × INLABCO

Custodyn · 14 / 20

Custodyn Biobank

Thermal Passport, Integrity Score & live consent

Sample BBK-2241-A3 · plasma aliquot

Consent: review

Location chain

Freezer FRZ-08 −79 °C
└ Shelf 2 −79 °C
  └ Rack 5 −78 °C
    └ Box 14 −78 °C
      └ Position A3

Integrity Score

82

2 freeze-thaw · 1 excursion · 38 min out

Thermal Passport · 72 h

Consent withdrawal cascades automatically to every aliquot of this donor and blocks release. MTA/DSA and IRB gates apply on distribution.

VISCHARI SOLUTIONS × INLABCO

Custodyn · 15 / 20

Custodyn IVF

Cryo-native witnessing & the end-to-end ART chain

Cycle ART-1187 · Patient masked · Day 5 vitrification

Dual-witnessed

1

Gamete

2

Embryology

3

Cryo / LN₂

4

Transfer

Step	Witness A	Witness B	Media / batch	Expiry
Insemination (ICSI)	S. Nair ✓	R. Iyer ✓	Fert · LOT G-2207	FEFO ok
Day 3 check	S. Nair ✓	R. Iyer ✓	Cleavage · LOT C-1183	FEFO ok
Day 5 vitrification	S. Nair ✓	R. Iyer ✓	Vitri · LOT V-0455	7 d
Cryo-store · Tank 2 / Cane 8	System ✓	R. Iyer ✓	—	—

Witnessing persists through vitrification, storage and thawing inside LN₂ — the documented blind spot of RI Witness and Matcher.

VISCHARI SOLUTIONS × INLABCO

Custodyn · 16 / 20

Audit

Immutable, signed audit log

Audit trail · today

Read-only · exportable

Time	User	Action	Reference
09:14	A. Pillai	Logged daily temp −79 °C	FRZ-08
09:48	R. Menon	Configured regime → ISO 20387 on	Site settings
10:05	System	Opened deviation (excursion)	DEV-2026-038
10:22	R. Menon	E-signed impact assessment	DEV-2026-038
11:30	S. Nair	Witnessed Day 5 vitrification	ART-1187
12:02	P. Das	Requested sample release	BBK-2210-B1
12:09	System	Blocked release · consent withdrawn	BBK-2210-B1
14:41	Auditor (RO)	Replayed chain of custody	BBK-2241-A3

VISCHARI SOLUTIONS × INLABCO

Custodyn · 17 / 20

Reports

Reports & compliance packs

Report library

Export CSV / PDF

🧬

Asset qualification status

🌡️

Excursion summary

🔁

CAPA register

📅

Calibration due

🧊

Sample integrity

📜

Consent & withdrawal

🧫

ART cycle audit

🛡️

Full audit trail

Compliance packs bundle the reports an auditor asks for under each regime — NABL, CAP, ISO 20387, ART Act 2021 — into one export.

VISCHARI SOLUTIONS × INLABCO

Custodyn · 18 / 20

Roadmap

From pilot to go-live

Phase 01

Discovery & regime

Confirm site workflows, roles, and the compliance regime(s) to enforce. Map existing logbooks.

Phase 02

Configure & pilot

Stand up the core, build logbooks, onboard one freezer farm or one IVF lab as a pilot.

Phase 03

Validate

IQ/OQ/PQ of the platform, e-sign and audit-trail verification, user training and SOP alignment.

Phase 04

Roll out & support

Expand site-wide, enable the vertical (Biobank / IVF), and move to ongoing support and AMC.

VISCHARI SOLUTIONS × INLABCO

Custodyn · 19 / 20

Decisions

Items to close before build

Compliance regime(s) — which regimes is the site audited against, and which is primary at go-live?
Pilot scope — single freezer farm, biobank, or IVF lab for Phase 02?
Vertical — Custodyn Biobank, Custodyn IVF, or core-only for the first deployment?
Sensor integration — connect existing temperature / LN₂ monitoring, or capture manually first?
Identity — SSO / Active Directory, or Custodyn-managed accounts?
Logbook inventory — how many existing SOP forms to migrate in Phase 01?
Hosting — cloud, on-premise, or hybrid, given data-residency rules?
Validation ownership — who signs the IQ/OQ/PQ of the platform itself?

Approximately one hour, 8 items.

VISCHARI SOLUTIONS × INLABCO

Custodyn · 20 / 20

Approval

Pilot engagement sign-off

Confirmation to proceed

By signing below, the undersigned confirm that the Custodyn platform scope, roles, compliance regime and pilot approach described in this walkthrough are an accurate representation of the engagement, and authorise the design and pilot phases to begin.

For the Client

Name

Designation

Date

For Inlabco & Vischari Solutions LLP

Name

Designation

Date