Industries / Pharmaceutical & life sciences
Distribution, wholesale, contract packaging and device supply sit comfortably in Business Central when lot, expiry and custody are configured properly. Fully validated GMP manufacturing is a different question, and it is answered plainly further down this page rather than in month six of a project.
Sub-models
Four positions, and what each one changes.
Lot, expiry and custody from receipt to despatch, with the conditions your establishment licence carries reflected in what the system will let people do.
You handle material you do not own and you transform it. Ownership, batch genealogy and reconciliation of issued against returned are the design questions.
Serial numbers and unique device identification rather than lots alone, and a field population you may have to reach one unit at a time.
Certificates of analysis travelling with the batch, and retest dates that behave differently from expiry dates and must not be modelled as the same field.
The processes, by name
If your QA or compliance lead uses the word, we implement the thing.
Which batch became which, through every transformation, from the supplier certificate to the customer who received it. Built on Business Central’s tracking layer, so it survives posting rather than living in a parallel register.
Expiry and retest dates captured at receipt, picking that takes the earliest expiring first, and stock approaching a date surfaced before it becomes a write-off.
Received but not releasable. Quarantined stock must be invisible to availability and to picking, or it gets promised while it waits on a certificate.
Serial-level identity where the regulation requires it, and a record of who held the goods at each step. Business Central holds serial numbers natively; reporting them into a national scheme is an integration and is scoped as one.
Restricted handling, reconciliation counts, and an audit trail showing who did what. This is as much a permissions design as an inventory one.
Temperature excursions recorded against the shipment, and a returns path that keeps returned stock out of saleable inventory until it is assessed or destroyed.
The part that gets tested
This is the section a pharmaceutical buyer should read first, because it is the one most vendors leave out.
Full computerised-system validation with formal IQ, OQ and PQ, change control over every update, and electronic signatures throughout is where Business Central starts to strain. Our own fit check scores validated production as a reason to look at a larger platform, and we are not going to contradict our own tool on a sales page.
Business Central keeps a change log and can be configured with approvals, but meeting a 21 CFR Part 11 interpretation end to end usually needs an extension and, more importantly, a validation programme you own. Software alone never satisfies it.
Reporting into a national track-and-trace scheme is an integration to a specific endpoint, not a feature to switch on. It is scoped as a project in its own right.
Our apps that earn their keep here
Software we already ship for this work.
Receiving, put-away, picking and counting
A mobile barcode WMS that runs inside Business Central. Scanner-driven receiving, put-away, picks, moves and counts — posting through BC’s own codeunits, so the ledger is the only source of truth.
On Microsoft AppSource (opens the marketplace listing in a new tab)
License plating and container handling
License-plate management for pallets and containers: build, split, merge and move whole plates instead of line-by-line quantities.
On Microsoft AppSource
Supplier invoice processing
Vendor invoice to posted purchase invoice, inside Business Central. The invoice is treated as a claim and reconciled against BC’s own order and posted receipt, so a mis-read number raises a legible exception instead of posting a wrong figure.
On Microsoft AppSource
Every app above is implemented by the team that built it — one contract, one accountable engineering group.
How we deliver
FitShipRunFit to standard first
Most requirements are configuration, not code.
Build like it ships
Custom work held to our marketplace bar.
Run it with you
We stay through your first month-end close.
Straight answers
Including the ones where the honest answer is that we are not the right firm.
Honestly, that is where it strains, and we would rather say so now than in month six. Full computerised-system validation, change control over every update and electronic signatures throughout push past what the standard product carries — our own fit check scores validated production as a reason to look at Dynamics 365 Finance & Operations or another enterprise platform. Distribution, wholesale, contract packaging and device supply are a different matter and sit comfortably here.
Yes. Business Central tracks lot, serial and package numbers natively on a dedicated tracking layer, and an item can carry more than one. The implementation risk is not whether it can, it is whether every posting path actually captures them — which is precisely what our warehouse work is careful about.
It is a regime you comply with, not a box the software ticks. Business Central provides change logging and approval workflows; a full interpretation generally needs an extension for signatures and, more importantly, a validation programme and documented procedures that belong to you. Any vendor claiming their ERP is "Part 11 compliant" out of the box is describing something that does not exist.
That is an integration to a named endpoint rather than a configuration, and it is scoped as its own project with its own testing and timeline. Business Central holds the serial identity; getting it to a regulator’s system is a build.
The other three
Next step
Thirty minutes, not a deck. We’ll tell you whether standard Business Central covers it, whether one of our apps does, or what a build would honestly take.
sales@dynamicspro.ca · Serving North America · 416-843-6575