ERP for pharmaceutical parallel import and distribution.
Repackage, relabel and re-serialise under GDP and GMP with far less effort, in a system customers have already taken through several authority inspections. Every batch released sooner, every figure of your business in real time.
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Batches released sooner, with e-signature.
Batch documentation, test results and release in one step. No batch leaves the warehouse without release.
Ready for inspection at any time.
QP release records, EMVO status history and source evidence are structured and to hand. You cover GDP and GMP with far less effort.
Every figure at a glance.
Stock, batches, repackaging and margin are visible at any time. Any figure you need can be calculated from the data.
Fewer detours between systems. More time for release.
Release without searching through folders.
The Qualified Person sees all data relevant to release on one screen. Mandatory checks, the four-eyes principle and the electronic signature are built in.
FMD re-serialisation without manual work.
When you repackage or relabel, the original unique identifier is decommissioned and an equivalent new one is placed. entroit talks directly to the EU Hub, and every status change lands in the audit trail with timestamp, batch and operator, without anyone typing it in.
Every repack to the right specification.
Bills of materials, master batch records and manufacturing matrices per variant are versioned and linked to the batch. Your line always works to the approved version.
Every import route fully documented.
Licences, supplier qualification and release workflow are stored per source. At inspection you present the whole chain, from the marketing authorisation holder to the wholesaler in the country of origin.
One platform, from repackaging to dispatch.
EMVO, serialisation, QC workflows and distribution work hand in hand. New variant, new source: the same processes apply straight away.
FAQ
Does entroit cover parallel distribution as well as parallel import?
Yes. Whether you distribute centrally authorised medicines under an EMA parallel distribution notice or import nationally authorised medicines under a licence from the competent authority of the destination country, the process in entroit is the same: qualified source in the EEA, goods receipt and quarantine, repackaging or relabelling to the approved version, QP release, FMD re-serialisation and distribution.
How does entroit cover supply chain documentation for parallel importers?
The platform covers supply chain documentation under the GDP guidelines in full, from the source in the EEA through importer and repackaging to the end customer. Supplier qualification, licence numbers and release workflow are stored in a structured way; evidence can be exported at the push of a button.
Which EMVO steps are automated?
entroit communicates directly with the EU Hub and automates decommissioning of the original pack, aggregation, re-coding of repackaged products and their new registration. Every status change is recorded in the audit trail with timestamp, batch and operator.
How is QP release handled?
Structured, multi-step release workflows with electronic signature, four-eyes principle and escalation when deadlines approach. The Qualified Person sees all data relevant to release (master batch record, deviations, OOS results) on one screen and releases with a full audit trail.
What does "GAMP 5 validatable" mean in practice?
entroit is built to be validated according to GAMP 5 principles and designed for the requirements on computerised systems in a GMP environment (EU GMP Annex 11). The validation itself is the user's responsibility. We offer the validation documentation (IQ/OQ/PQ, risk assessments, test protocols) as an optional service.
Which inspection documents can entroit produce at the push of a button?
Audit trails (by batch, user or period), QP release records, EMVO status history, source evidence, goods receipt and quarantine documentation, master batch records and track and trace reports.
How much work is switching from our existing system?
We import your master data (items, sources, customers, suppliers); historical batch data can be migrated if you wish. You book your first new goods receipt in entroit while old data stays available for reporting.
Every batch traceable. From day one.
Thank you! We will send you your access within one business day.
See our privacy policy.