ERP for the pharmaceutical and cosmetics industry

Electronic batch record, pharmaceutical release, status control and expiry management: the ERP built for a GMP environment where the data carries accountability.
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ERP for the pharmaceutical and cosmetics industry

Nothing leaves without release

On a site operating under GMP, a manufactured product is not an available product. It stays in quarantine until the release decision, taken on the strength of a complete batch record and signed by a named responsible person.

The whole information system has to follow this logic of statuses. An ERP that makes stock available as soon as production is declared organises, structurally, the issue of unreleased batches.

The batch record itself often stays on paper: several dozen pages per batch, read line by line before release. It is the main delay between the end of manufacture and availability, and the main source of documentary discrepancies at inspection.

Nothing leaves without release
Expiry, weighing and data integrity

Expiry, weighing and data integrity

Date control is a fundamental constraint: issue nearest to expiry (FEFO), calculation of the finished product date from the most constraining component, automatic blocking of an expired component. Issuing on FIFO instead of FEFO is paid for in destroyed stock.

Central weighing must be guided and recorded: expected component, tolerance, check on the status of the batch being weighed. In cosmetics, ISO 22716 sets comparable requirements, and 21 CFR Part 11 governs the electronic signature as soon as a North American market is in view.

AVIA ERP carries the quarantine and release statuses, takes the batch record off paper, applies FEFO on issue, guides the weighing sequence and logs every intervention in a non-repudiable manner.

What a GMP site expects from its ERP

Electronic batch record

Built up as manufacture proceeds, with in-line checks, traced deviations and review by exception rather than page by page.

The direct benefits for your industrial company

Release in hours rather than days

Review by exception replaces the page-by-page check of a paper record.

No unreleased batch leaves the site

The prohibition is carried by the statuses in the system, not by the vigilance of a storekeeper.

Fewer destructions on expiry

FEFO applied on every issue runs the batches down in the right order, automatically.

An inspection that rests on the system

Records, deviations and signatures are produced from the tool, with nothing to reconstruct.

They trust us

Averaland

Cosmetics manufacturing.

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