Orders.Lots.Documents.Approvals.Invoices.Seal Portal.For your clients.
Seal Portal shows each client their own orders, lots, documents and invoices on the record you already keep. They see only what you share, as it happens.
The portal of Rookery Bio, the client, on its order SO-1182, Tuesday 24 November: the 40,000 vials of mAb-24 in shipment SH-0771 leave Blubber Biologics at 07:30, and the shipper's logger shows them between 2 and 8 °C the whole way to delivery at 13:10. Beside them is what the quality agreement between Blubber and Rookery names, shared by Blubber's QA: the deviation's summary on 10 November, the day it was agreed, and change notice CN-112, both sent by S. Amato and CN-112 acknowledged by D. Hale at 15:10 that day; the earlier lots assessed on 13 November, with no product impact; the deviation closed on 20 November after the sterility result; and the certificate of analysis and the batch summary at the lot's release on 23 November, certified and released by E. Marchetti, Qualified Person. The invoice for $2,480,000 is issued on delivery, and Rookery's action is to confirm receipt
Portal › Rookery Bio, the client › SO-1182
Delivered 13:10
Ordered
In production
Released
Shipped
Delivered
Invoiced
40,000 vials, mAb-24Tue 24 Nov, 13:12
Shipment SH-0771
4.8°CDelivered 13:10, in range for 5 h 40 min
Limit 8 °CTarget 5 °CLimit 2 °C
07:3009:0010:3012:0013:10
Shared with you
By Blubber Biologics
Your lots, their deviation summaries and change notices, as your quality agreement names; shared by Blubber's QAThe deviation and the change it brings, shared with you the day DEV-041 was agreedWhat happened, its two causes, the 61 vials and four earlier lots to assess; shared by S. Amato, QASOP-FIL-007 v13, sent 11:32 under your quality agreement with the right to object; acknowledged by D. Hale, effective 21:34Lots 26-0905, 0908, 0912 and 0914: plates within limits, sterility passed, the open vials rejected each timeClosed by S. Amato, QA, with 19 of 19 results in; bulk hold and endotoxin retest accepted 13 NovCertified and released by E. Marchetti, QP, 23 Nov 10:12; from the lot's 19 of 19 resultsDrafted by Neil from the lot's 1,912 entries; shared by E. MarchettiScanned out of Blubber's cold store against SO-1182The shipper's logger, read on receipt; 5 h 40 min between 3.9 and 5.4 °CEvery reading, on the shipment's record40,000 vials at $62.00; drafted by Neil, approved by Blubber's financeConfirm receipt
One record. Nothing to send.
Clients ask by email, and someone answers from the record by hand. The portal is that record, opened as far as you choose.
Compared on
By email and spreadsheet
Seal Portal
A client's question
An email, answered when someone can
Answered on the lot, in 12 minutes
A certificate of analysis
A PDF attached to an email
The signed certificate, on its lot
A deviation on their lot
Written up days later
Drafted by Neil, shared by QA
Their shipment
A logger's report, on request
Every reading, as it is taken
Their approval
A signature page, scanned back
An e-signature on your record
What they see
Whatever was attached
Only what you share
Sharing
QA chooses what each client sees: their lots, their documents, their deviations. Everything else stays yours.
Sharing lot 26-0917 with Rookery Bio, the client, in Seal Portal on Monday 23 November, the morning E. Marchetti, Blubber Biologics' Qualified Person, certifies and releases it. Rookery sees what the quality agreement between them names. It has had deviation DEV-041's summary and change notice CN-112 for SOP-FIL-007 v13 since 10 November, the notice acknowledged by D. Hale at 15:10 that day, the assessment of the earlier lots, with no product impact, since 13 November, and DEV-041's closure, after the sterility result, since 20 November. Neil drafts a summary of the batch record, E. Marchetti reads it and at 10:20 shares it and the signed certificate of analysis, six of the lot's ten records shared in all; the batch record is Rookery's on request, the investigation notes and the lot's costing stay internal, and Line 2's other lots are other clients'. At 14:20 the audit trail shows D. Hale of Rookery Bio opening the certificate
Portal › Sharing › Rookery Bio, the client
Shared 10:20
Lot 26-0917, mAb-24Mon 23 Nov, 14:20
What Rookery Bio sees
6 of 10recordsShared by E. Marchetti at 10:20
In Rookery Bio's portal
Deviation DEV-041, summary10 Nov
Change notice CN-11210 Nov
Earlier lots assessed, no product impact13 Nov
DEV-041 closed after the sterility result20 Nov
Certificate of analysis, lot 26-091723 Nov
Batch summary, lot 26-091723 Nov
This lot's records
Lot 26-0917
The quality agreement names what Rookery sees; nothing is shared until QA shares itCertified and released by E. Marchetti, QP, at 10:12; from the lot's 19 of 19 resultsDrafted by Neil from the lot's 1,912 entries; read and shared by E. MarchettiDrafted by Neil from DEV-041: what happened, its two causes, the 61 vials, the earlier lots to assessFrom this lot's DEV-041, for v13, which runs from lot 26-0918. Sent 10 Nov 11:32; acknowledged by D. HaleLots 26-0905, 0908, 0912 and 0914: plates within limits, sterility passed, the open vials rejected each timeClosed by S. Amato, QA, on 20 Nov, once this lot's sterility result was inNot shared; Rookery Bio can ask for it under the quality agreementBlubber's own working notes; never in a client's viewSeal ERP's cost of the lot; never in a client's viewLots made for other clients are never in Rookery Bio's viewThe certificate, opened in Rookery Bio's portal; every view is in the audit trailShare with Rookery Bio
Questions and approvals
A client asks on the lot it is about. Neil drafts the answer from the record, your QA sends it, and their approval is signed in place.
The quality lead of Rookery Bio, the client, D. Hale, in Blubber Biologics' portal on lot 26-0917: having read the certificate of analysis and the batch summary, they ask on Monday 23 November whether any of the 61 rejected vials were stoppered. At 14:38 the answer arrives, drafted by Neil from the batch record and DEV-041 and sent by E. Marchetti, Blubber's Qualified Person: none was, all 61 were open between the filling needles and the stoppering station when the line stopped at 02:08, and all were rejected at the restart. At 14:52 D. Hale signs the lot's acceptance for shipment, and order SO-1182 is cleared to ship on Tuesday at 07:30
Portal › Rookery Bio, the client › Lot 26-0917
Accepted 14:52
D. Hale, QAAsked by D. Hale, QAMon 23 Nov, 14:52
Were any of the 61 rejected vials stoppered?
With Blubber's QA
No
All 61 were open, between the filling needles and the stoppering station, when the line stopped at 02:08. None was stoppered or capped, and all 61 were rejected at the restart.
Batch record, step 4.4DEV-041, section 2
Drafted by Neil from the record. Sent by E. Marchetti, QP.
Your sign-off
Lot 26-0917
Signed on Blubber's record, with its audit trailOpened by D. Hale at 14:20; certified and released by E. Marchetti, QP, at 10:12Opened by D. Hale at 14:22Asked on lot 26-0917, about DEV-041; answered in 12 minutesSigned by D. Hale with password and authenticator code; kept on Blubber's record with its meaningShipment SH-0771 leaves Blubber's cold store on Tuesday at 07:30Accept the lot
Questions about Seal Portal.
Who is it for?
Manufacturers whose clients ask about their own work, whether they supply a partner, make for one under contract or test for one: where an order is, what happened on their lot, and the documents that go with it.
What does a client see?
Only what you share: their orders, the stage of their lots, the documents you share with them, their shipments and their invoices. Each is a view of the live record, with its own access and its own audit trail.
Do clients need Seal?
No. A client signs in to your portal in a browser, and needs no Seal licence of their own.
Can a client sign?
Yes. Where your quality agreement asks for their approval, they sign in the portal with a password and an authenticator code, and the signature is kept on your record.
Does it need Seal ERP?
No. The portal shows what Seal already records: lots, documents, deviations and results. With Seal ERP it shows orders, shipments and invoices too.
Is it under our name?
Yes. The portal carries your name and sits at your address. It is part of the service you offer your clients.
Where is Neil in it?
Drafting. It writes the client's summary of a deviation, and the answer to their question, from the record and with its sources. Nothing it drafts reaches a client until someone on your QA team has read it and sends it.
See your process in Seal.
Working 48 hours after we agree its scope: tested, with evidence your QA approves.
