Labeling in pharma, medical and cosmetics

In pharma, medical devices and cosmetics, the label is part of your quality system. A wrong label can make a product unusable or put patients at risk. That is why labels have to be validated, traceable and centrally managed. Giesbus implements Loftware so that every label comes from controlled data and every change is recorded.

What pharma, medical and cosmetics companies run into

Validation and compliance according to GMP, MDR and FDA 21 CFR Part 11.
Changes without a record: who changed what, and when?
Outdated label software that no longer meets requirements for security and integrations.
UDI, lot numbers and expiration dates that have to be exactly right on every product.
Fast product launches in cosmetics, where new labels have to be ready quickly.

How Giesbus solves this

Loftware Cloud offers central label management with version control, approval steps and an audit trail. Labels take their data from a controlled source, such as your ERP or an Azure SQL database, so nothing is retyped. Giesbus guides the implementation, the migration of existing labels and the connection with printers and labeling machines.

Read more about the compliance options on the page Loftware Cloud Compliance.

In practice

Palmedic

Manufacturer of medical devices. An outdated NiceLabel 2017 environment replaced by Loftware Cloud Essentials with Azure SQL, connected to a Novexx XPA 934 labeling machine.

→ Read the Palmedic case

Rotaid

Manufacturer of AED wall cabinets, distributed worldwide. Control over its own label management with Loftware Cloud Essentials, because a wrong label on a medical device is not an option.

→ Read the Rotaid case

LOOkX Cosmetics

Skincare and make-up. Loftware Cloud Designer with new thermal printers: central label designs and faster changeovers for new product launches.

→ Read the LOOkX case

Frequently asked questions about labeling in pharma, medical and cosmetics

Does Loftware support validation according to GMP and FDA 21 CFR Part 11?

Yes. Loftware Cloud has version control, approval steps, electronic signatures and an audit trail. This supports the validation of your labeling process. The validation itself remains a task within your quality system; Giesbus helps with the setup.

Can we move our old NiceLabel environment?

Yes. At Palmedic we fully migrated a NiceLabel 2017 environment to Loftware Cloud Essentials, including the connection with the labeling machine on the packaging line.

Can Loftware create UDI labels for medical devices?

Yes. Loftware supports the barcodes and data needed for UDI, such as GS1 DataMatrix with product code, lot number and expiration date. The data comes from your own system.