(hi - reposting here on the all-member forum for greater visibility, I am new here, so sorry for the duplication - I am learning my way around 😀)
Posting here because the audience spans pharma, biotech, and medical device, and the question cuts across all three.
We're scoping version 2.0 of our customer-facing portal for a secondary packaging operation serving pharma, biotech, IVD, and medical device accounts. The goal is to build on what has worked for the past decade, consolidate the documents and workflows that currently live across email threads, shared drives, and one-off requests - things like CofCs, change notifications, validation records, audit documentation, and artwork approval status.
Before we lock in scope, I want input from the QA, regulatory, and packaging engineering side on what actually helps versus what becomes another login you don't use.
A few specific questions:
- What document types do you most often need from a secondary packaging supplier, and how do you want them delivered - portal pull, email push, or both? Curious how regulatory pressure - QMSR on the device side, GMP and serialization on the pharma side - is shaping what you expect from suppliers on document traceability and change history.
- For change notification, do you prefer formal SCN workflows inside the portal with acknowledgment tracking, or does that duplicate what your QMS already does?
- How important is real-time visibility into open CAPAs, deviations, or in-process validations on your jobs - or is that information you'd rather receive only when it's been closed and approved?
- For order status, inventory, and shipment data - do you want that surfaced in a supplier portal, or do you expect it to flow directly into your ERP or WMS? Where have you seen that handoff actually work?
- Anything you've seen done well - or badly - on a supplier portal that shaped your view?
Happy to share back what we learn if there's interest.
Thank you in advance!
Steve
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Steve Mahr CPP
SVP, Life Sciences and Regulated Packaging
KP
(805) 701-9342
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