Every lot released by a person, every device traceable to the customer.
Quality holds and certificates of analysis, in-process checks, outsourced sterilisation, recalls and GS1 labels. Tathven Agentic ERP runs a medical-device or biotech plant from the raw polymer to the hospital invoice, with an AI assistant that never releases anything on its own.
Sterile disposables, devices and kits, made in clean rooms, sterilised in-house or outside.
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Biotech and diagnostics
Reagents, kits and consumables that live and die by their lot and expiry.
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Contract manufacturers and their suppliers
Polymers, components and packaging that must be cleared before they are used.
The pain points
And how Tathven answers each one
Quality and release
1
Nothing moves until quality says so
The pain
Material arrives and is used before anyone has tested it. Or it sits in a corner for a week because nobody knows it is waiting. The release lives on a paper form that an auditor has to take on trust.
How Tathven solves it
Items marked as quality-controlled arrive on hold and cannot be issued until they are cleared. Only a person with the clearance right can release a lot, in full or in part, and must write down why. A second person’s approval can be required for each decision. Every decision is journaled with who, when and why, and the journal is never edited.
✨ How the agentic ERP helps
Ask “which lots are waiting for a quality decision?” every morning. The assistant never clears a lot itself.
Stock waiting for a quality decision cannot be issued.Every clearance, with who cleared it and when.
2
A certificate typed by hand
The pain
Test results are written in a register, and the certificate of analysis is typed from them later. Sooner or later a number is copied wrong, or a lot goes out with a test missing.
How Tathven solves it
Specifications are versioned, test results are recorded against them, and the certificate of analysis prints from the recorded results. A lot cannot be released to use until every required test has passed. The supplier’s own certificate is filed against the lot, and a corrected certificate becomes a new version, not a replacement.
3
An out-of-spec result, and then what?
The pain
A result fails. Someone retests until it passes, the investigation is an email thread, and the same defect comes back next quarter.
How Tathven solves it
An out-of-spec result opens a laboratory investigation with the retest rules built in. Defect reports are numbered and carry the root cause, corrective and preventive actions with owners and due dates, and an effectiveness check, with reminder mails until they close. A defect report can be raised from a production run’s rejects, from a lot, or from a customer’s complaint ticket. A Pareto view shows which defects keep coming back.
4
A recall that takes days
The pain
A supplier warns that a polymer batch is suspect. Finding every device made from it, and every hospital that received one, takes days of spreadsheets.
How Tathven solves it
Search by your own lot code or the supplier’s batch code. The recall view traces the lot through stock movements, issues and orders to every customer and parcel it reached. Each item is tracked by batch or by serial number. Labels print as GS1-128 barcodes with the GTIN, lot, manufacture and expiry dates, and scanning a label finds the item and lot.
✨ How the agentic ERP helps
Ask “which customers received lot 2417?” and the assistant answers from the same trace.
Each item with its live lots and stock.
5
“Who approved this, and when?”
The pain
Auditors ask who approved a release or changed a price. The answer is a signature on paper, or nobody remembers.
How Tathven solves it
The approval matrix decides which documents need approval and by whom, with a second person where you require one. Electronic signatures can be switched on for each document type: the signer re-enters their password and states what the signature means (for example, released or approved), and the signature is bound to that record. Change history keeps the old and new values of audited records.
✨ How the agentic ERP helps
Documents that need a signature cannot be prepared by the assistant at all. A person signs them.
Who approves what, with a second person where you require one.Old and new values, who changed them and when.
Production
Production orders, each with its status and progress.
6
The clean room is the bottleneck
The pain
Clean-room time, welders, sterilisers and leak testers are booked on a whiteboard. A rush order upsets the week, and nobody sees which orders slip.
How Tathven solves it
Each clean room, welding line, steriliser and tester is a work centre with its own machines, working calendar, machine-hour rate and operator pool with skills and leave. Production orders are scheduled on a board against what each machine can do, and auto-schedule places open orders by due date.
✨ How the agentic ERP helps
Ask “which production orders are running late, and why?” or “what happens if this rush order goes first?” The assistant reads the schedule, then prepares a reschedule or overtime for you to confirm.
One day on the schedule board, machine by machine.
7
Checks done on paper, after the run
The pain
First-piece and in-process checks are recorded on a sheet at the machine. A failed check is found after the batch is made.
How Tathven solves it
Each operation can carry its own checks: a measurement between limits, a yes/no or a note, taken at first piece or at stop. A failed check marks the run. A run cannot be stopped while a required check is outstanding, and a defect report can name the check that failed.
The shop floor screen: start, pause and stop each run.
8
Sterilisation sent outside
The pain
Devices go to an outside steriliser and come back days later. What was sent, what came back and what is still there lives in challans.
How Tathven solves it
A job order sends the batch to the sterilisation contractor, at the contractor’s rate card, with a date it is due back. Material is issued against the job order, and the balance comes back against it. GST’s ITC-04 return for goods sent to job workers is built from the same records. If you sterilise in-house, the steriliser is a work centre like any other.
✨ How the agentic ERP helps
Ask “what is still with the sterilisation contractor?”
9
Machines that stop, and nobody writes down why
The pain
A welder breaks down, a clean room has an excursion, and the reason is never recorded. Utilisation is a guess.
How Tathven solves it
The shop floor screen starts, pauses and stops runs, with good and rejected quantities and the reason for every stop. Utilisation and OEE show how much of each machine’s time made good product, and what the idle time was spent on. Preventive maintenance is planned per machine, and a daily mail lists what is due or overdue.
✨ How the agentic ERP helps
Ask “how much downtime did the welding hall have this month, and why?”
Utilisation and OEE by work centre, with why machines stood still.
Planning and costing
10
Expired stock used, fresh stock left behind
The pain
Components and reagents expire on the shelf because the newest lot was picked first. Buying is done by feel.
How Tathven solves it
Goods issue picks first-expiry-first, and expired lots are kept out of it. Material planning works out what open orders need against stock and open purchases, and proposes the purchase and production orders for you to confirm. A weekly mail lists the lots near their expiry.
✨ How the agentic ERP helps
Ask “what should I reorder this week?” and the assistant prepares the purchase order for you to confirm.
The material plan: what to buy or make, and by when.Stock bin by bin, lot by lot.
11
What a device really costs
The pain
The standard cost was set once. Material prices, scrap and contractor rates have moved since, and margins on some devices have quietly gone.
How Tathven solves it
Costing orders work out the cost of a run from the bill of materials, job rates, expected wastage and your overhead. The cost-drift view compares the actual cost of completed orders with the standard and shows which devices have drifted, by how much. Anything left in work in progress when an order is closed goes to a variance account, not into stock.
✨ How the agentic ERP helps
Ask “which devices has cost drift flagged?”
Actual cost against standard, device by device.A bill of materials for every device.
Sales and finance
12
Hospitals, distributors and government buyers
The pain
Hospitals buy on credit, distributors want terms, government orders come through GeM, and a consignment leaves before anyone checks the money. Returns come back and go straight onto the shelf.
How Tathven solves it
Every buyer has its own credit days and limit. An order is cleared for dispatch only when it is paid, unless the buyer is on credit terms and within them. A carrier dispatch cannot be saved without its tracking number. Government orders come in through the GeM connector. A customer return goes back into a lot on quality hold, so it is checked before it can be sold again.
13
GST and the books, closed on time
The pain
Devices, parts, packaging and services carry different GST rates. The month never closes because stock and accounts disagree.
How Tathven solves it
A medical-device HSN catalogue sets devices and diagnostic kits at 5%, and parts, packaging and services at their own rates. Every stock movement reaches the books by itself. GST returns (GSTR-1, GSTR-3B and the annual return) are built from the tax ledger, and a month can be locked once it is closed.
Every voucher in the day book, with its GST lines.
One system, and an assistant you can trust
14
An assistant that knows the rules
The pain
In a regulated plant, nobody wants software that does things on its own.
How Tathven solves it
Tathven’s AI assistant answers from your own data, within your own access rights:
lots on hold;
recalls;
late orders;
downtime;
cost drift.
It can prepare a purchase order, a schedule change or overtime, and move documents through their approval steps, each on a card you check and confirm. It never clears a lot, never signs, and cannot touch documents that need an electronic signature.
15
One system, not five
The pain
Quality, production, stock, sales and accounts in separate systems means the batch record is stitched together for every audit.
How Tathven solves it
Quality decisions, production runs, stock movements, sales and the books are one system, linked by the lot. Tathven AI Workspaces keeps specifications, supplier certificates and documents beside the records they belong to. The CRM turns a customer complaint into a ticket, and the ticket into a defect report.
Feature by feature
What you get
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Quality holds
Quarantine on receipt, release by a named person with a reason, second-person approval, decision journal.
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Specifications and certificates
Versioned specs, test results, certificate of analysis, supplier certificates.
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Investigations and CAPA
Out-of-spec investigation, defect reports with corrective and preventive actions, effectiveness checks, Pareto.
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Traceability
Batch or serial tracking, GS1-128 labels with GTIN, lot and expiry, scanning, recall to customer and parcel.
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Production
Work centres with machines and operator pools, scheduling board, in-process checks, shop floor runs, utilisation and OEE, maintenance.
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Job work
Outsourced sterilisation and processing, material issue and return, ITC-04.
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Planning and costing
First-expiry picking, near-expiry mails, material planning, costing orders, cost drift, production variance.
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Sales
Credit terms and dispatch rules, hospitals and distributors, GeM, returns into quality hold.
An assistant that answers and prepares, and never releases or signs.
Tathven Agentic ERP
Start with your next lot.
Bring your specifications, your clean rooms and your contractors. Tathven Agentic ERP brings the rest. Choose Inventory or Manufacturing, and grow without changing systems.
