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Purchasing. Inventory. Planning. Costing. Invoicing. Seal ERP. On the floor's record.

Seal ERP runs on the record production and quality already keep, batch record or device history record. Nothing is keyed across or reconciled.

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Lot 26-0917 in Seal ERP on Monday 23 November: when E. Marchetti, the Qualified Person, certifies and releases its 41,339 vials, 17 days after the fill (of 41,860 filled, 61 were rejected at the stop, 318 at inspection and 142 sampled and retained), its cost closes from the batch record, the scanner and the LIMS at $39.08 a vial, $1,615,400 for the lot against a standard of $1,611,552; the $3,848 it is over is the 21 minute line stop, $1,470, and the 61 rejected vials, $2,378, of deviation DEV-041; an order takes 40,000 vials and Neil drafts the invoice for finance, who approve it before it posts to the ledger in NetSuite
ERP › Lots › 26-0917
Released 10:12
  1. Planned
  2. Issued
  3. Filled
  4. Released
  5. Allocated
  6. Invoiced
mAb-24 drug productMon 23 Nov, 10:14

Cost a vial

$39.08$1,615,400 over 41,339 vials
Over its standard of $1,611,552$3,848
  • 21 min line stop$1,470
  • 61 vials rejected$2,378

Both are DEV-041. Neil puts five jams since August at about $18,940.

Held by QA
0
Free to promise
1,339
Promised
40,000

41,860 filled, 61 rejected at the stop, 318 at inspection, 142 sampled and retained, 41,339 held41,860 filled, 61 rejected at the stop, 318 at inspection, 142 sampled and retained, 41,339 released

Ledger

Lot 26-0917
Finance approves, then it posts to your ledger in NetSuiteDS-26-0331 as the batch record weighed it at dispensing, at its cost10R vials, 20 mm stoppers (ST-5512) and caps, each lot scanned onto Line 2The batch record's own start and end, 00:20 to 10:00, at $4,200 an hourThe lot's 19 tests in the LIMS at each method's cost: 19 of 19 passed, sterility lastCertified and released by E. Marchetti, QP: DEV-041 closed, EM and glove plates within limits, 19 of 19 results including sterilityThe disposition on DEV-041, at standard cost; DEV-041 closed Fri 20 Nov, after the sterility resultThe order of Rookery Bio, the client: the first released lot that meets its shelf life40,000 at $62.00, drafted by Neil for finance; issued on delivery

One record. Nothing to reconcile.

An ERP beside an MES keeps a second copy of the floor, and an interface to keep it honest. Seal ERP reads the floor's own record.

Compared onAn ERP beside your MESSeal ERP
A lot's costAt month end, from keyed totalsAt release, from the floor's entries
A varianceA number nobody can explainExplained by its deviation, to the dollar
A released lotA status an interface keeps in stepFree to sell the moment the QP releases it
A shortageFound at the lineFound when the order comes in
ValidationTwo systems and their interfaceOne system, tested on every change

Purchasing and receiving

One scan receives a delivery against its order and quarantines it. Nothing reaches a line until QC releases it.

See certificate review
A delivery of 120,000 stoppers for Line 2 in Seal ERP: one scan receives Halden Elastomers' lot H-22871 against PO-3319 and quarantines it, Neil reads the certificate and matches the invoice for AP to approve, QC samples and tests it, and when QC releases it on Friday it moves to A-14, free to issue and enough for Line 2's next three lots
ERP › Receipts › GR-2207
Released Fri 09:05
  1. Ordered
  2. Received
  3. Quarantined
  4. Sampled
  5. Tested
  6. Released
Stoppers 20 mm, ST-5512Fri 13 Nov, 09:05

Can it be issued to Line 2?

YesReleased by QC. 120,000 at A-14
Stopper coverShort for Friday's lotCovers all three lots
20,800 released120,000 in quarantine120,000 released
  1. Fri26-0920
  2. Mon26-0921
  3. Tue26-0922
Three-way matchWaiting for the invoiceMatched, $21,600
Order
120,000
Receipt
120,000
Invoice
120,000 at $0.18

Receipt

GR-2207
Free to issue to Line 2One scan of the supplier's label by D. PetrovLine 1 of PO-3319, raised 2 Nov when cover fell under two lotsEvery received lot is held until QC releases itHalden's certificate against SPEC-ST-5512 v4, for L. Haddad in QC to confirmThe sampling plan for 120,000 pieces, raised in the LIMSHalden's invoice 7731: quantity and price agree; $21,600 for AP to approveSigned by L. Haddad in the LIMS; the stock is the same recordLine 2 can now be issued from lot H-22871

Planning

The schedule knows what is released, who is trained and which line is down, so it moves before the shortage does.

See schedule alignment
Planning Line 2 in Seal ERP: asked whether a new order, SO-1190, can ship by 11 December, it checks stock, the lab, training, maintenance, calibration and how long a lot takes to be released on the same record, Neil finds Friday's fill 21,200 stoppers short and proposes starting that lot at 14:30, once the delivered stoppers are out of QC, and the planner accepts the plan: the order's two lots, filled 16 and 17 November, are released by 4 December
ERP › Plan › Line 2
Promised 11 Dec
P. Sandoval, planningWed 11 Nov, 16:10

Can SO-1190 ship by 11 Dec?

YesWith one move: lot 26-0920 starts Friday 14:30

Checks

SO-1190, 80,000 vials
Nothing moves until the planner acceptsStock by lot and status, and PO-3319's delivery date62,800 less Thursday's 42,000 leaves 20,800 of the 42,000 it needsThe lab's own schedule for its 13 samplesProposed by Neil: stoppers loaded by 14:00; it ends 00:10 Saturday, before the maintenanceFriday's roster against the matrix: 9 of 11 trained, the last two due Thu 06:00CAPA-019's action, owned by T. Nakamura; Line 2 is down that dayB-04's record: calibrated 3 Nov, in date for every fill in this planThe QP's last four releases took 17 days from fill on average, 14 of them the sterility testAccepted by P. Sandoval at 16:20; SO-1190 promised to Rookery Bio, the client, for 11 Dec

Questions about Seal ERP.

Is Seal ERP a whole ERP?

It runs what a GxP manufacturer buys an ERP for: purchasing, receiving, inventory, planning, lot costing, orders and invoicing. The general ledger, payroll, tax and consolidation stay in the finance system you close your books in: finance approves, then each entry posts to your ledger there.

Is it only for drug products?

No. The record under it is a batch record for a drug product and a device history record for a medical device, by lot or by serial number, and the ERP reads either. This page follows one lot of a drug product.

Do we have to replace SAP or NetSuite?

No. Neil already does supply chain work from the exports of the ERP you run today: certificate review, invoice matching, demand planning and seven more jobs. Start with one. Move inventory or lot costing across when you choose, and keep closing your books in NetSuite, SAP, Dynamics 365 or QuickBooks: Seal posts to it. Replace it later, or never.

How is it validated?

Your QA validates it as they do the platform: every change comes to them tested, with its evidence, and takes effect only when they approve it. The ERP's tests run with production's and quality's, so there is no interface between them to qualify.

Is the client's portal part of it?

It is a product of its own, Seal Portal, on the same record. With Seal ERP a client sees their orders, shipments and invoices in it.

Where is Neil in it?

Doing the reading. It checks a supplier's certificate against the specification, matches an invoice to its order and receipt, explains a variance from the deviation behind it and drafts the invoice. Your people decide: QC releases materials, your QA or Qualified Person releases each lot, and finance approves what posts to your ledger.

See your process in Seal.

Working 48 hours after we agree its scope: tested, with evidence your QA approves.

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