For medical device manufacturers

Your ERP plans what is on the bill of materials, and in a device plant that is a real list: purchased components and subassemblies, sterile barrier packaging, labels and IFUs, the medical-grade adhesive that goes into the joint. Those it can see. What it does not plan is the second list, the materials the process consumes rather than the ones the device is built from: cleanroom gloves, gowns and coveralls, wipes and swabs, solvents and process aids, single-use tooling, calibration and metrology items, sterilization and environmental monitoring supplies. Nothing plans those, because there is no BOM line to plan them from. And the two lists cross in an awkward place. Nine of the twelve families a device plant stocks arrive lot-controlled, and most of the lot-controlled ones sit on the off-BOM side, which means the materials your procedures care most about are the materials your planning system sees least. Arda puts the same scannable card on both lists. The off-BOM materials get a reorder signal for the first time, and the on-BOM ones get a second one at the point of use.

Arda is a replenishment system, not a quality system, so it does not build your device history record and it does not replace lot genealogy in your ERP or eQMS. What it changes is the condition that most often puts a gap in those records. When a bin runs out mid-build, someone improvises, and the improvisation is what becomes a deviation. Arda keeps the material there. Alongside that, every scan is a dated event, so the pull and reorder history for each bin is available rather than living in one person's memory or a spreadsheet updated on Fridays.

Yes, and it is designed to leave both alone. Your ERP keeps doing planning, costing and on-BOM material. Your QMS keeps doing document control, records, nonconformances and CAPA. Arda runs one loop, the replenishment loop, and slots in where ERP and MRP are weakest: the off-BOM materials the floor burns through that never appear on a bill of materials. It integrates with QuickBooks, NetSuite, Odoo, Xero, Shopify, Stripe, Airtable, Make and Zapier, plus a REST API, so there is no rip and replace and nothing in your validated stack has to move.

Arda is not a validated quality system and no vendor can hand you validation. ISO 13485 clause 4.1.6 and 21 CFR 820.70(i) put validation of software used in the quality system on the manufacturer, for its intended use, in its own environment, at a depth proportionate to risk. The same is true of 21 CFR Part 11: compliance is a property of how you implement and control a system, not a badge a product carries. What that means in practice is that you define Arda's intended use, decide whether it touches a quality record, and validate accordingly. Most teams start Arda outside the validated boundary, on off-BOM consumables, which is both the fastest way to prove it and the lowest-risk place to begin.

Two bins of the same item sit at the point of use, each sized to cover the supplier's lead time plus a cushion. The floor consumes the first bin, then pulls the second forward. With Arda, the card on the empty bin gets scanned and the reorder fires automatically, so the first bin is refilled before the second runs down. Nobody counts and nobody reads a number off a screen. Inside a controlled environment the card and its placement are yours to specify under your own contamination control procedure, the same as any other item you bring through the ante-room.