Labeltrix Pharmaceutical Labeling Software
Pharma label software for quarantine, sampled and approved labels, with QA-approved templates and a complete audit trail, built for 21 CFR Part 11.
What Our Pharmaceutical Labeling Software Delivers
Batch, lot, vendor, weight and container number captured on a label for every container received.
Move each container from quarantine to sampled to approved, with colour coding that matches your SOP.
Templates are reviewed by QA once and saved as masters, so only approved formats reach the floor.
Every print is tied to an individual login with a date and time stamp, replacing paper log books.
Designed around the FDA standard for electronic records, with validation documentation available.
No server setup at your site. Labeltrix runs on the cloud in a simple subscription model.
How 'Labeltrix' our Label Print Application Works: From Raw Material to Approved Batch
Raw Material Receipt and Quarantine
Labeltrix generates a quarantine label for every container received, capturing batch details, lot number, and vendor information. Container-specific details such as weight and container number are recorded individually, even when the batch information is shared across an entire consignment.
These labels are printed on GMP-grade label stock manufactured in-house by Codentrix, one of the leading Barcode label manufacturers in Chennai.
Sampled
Once your quality team draws samples, Labeltrix allows you to generate a sampled label that replaces the quarantine label, moving the container to the next stage in your GMP process. Colour-coding can be configured using pre-printed labels to match your existing SOP.
Approved
When testing confirms the material meets specification, Labeltrix generates an approved label and Quality team clears the material for release to production.
The Labeltrix Difference
For every quarantine, sampled, and approved label, Labeltrix generates, it maintains an audit trail of who generated it and when. This replaces manual log books with a continuous, built-in history for every batch label, down to individual containers, for example 50 drums of hydrochloric acid, with a record of who prepared its quarantine, sampled, and approved labels.
Label Templates and QA Approval Workflow
Create Template
A template is created for each format: quarantine, sampled or approved.
QA Review
Every template is routed to QA for review and approval.
Master Saved
Approved templates become masters, a one-time setup reused for every batch.
Batch Printing
Batch labels are printed only from approved masters.
Labeltrix brings your label design and approval process into the electronic version. A template for each format, quarantine, sampled, or approved, is created in the system and routed to QA for review, the same design and approval process your team already follows on paper.
Once QA approves a template, it becomes a master, available for immediate use in production. Masters are a one-time setup: an approved format stays in use until the format itself changes, so your team is not recreating templates for every batch.
For every new batch, the personnel select the correct approved master label and generate the batch labels. Since printing only happens against an approved master, every label issued on the floor carries a format your QA team has already approved, with no risk of an obsolete or unapproved version being used.
Complete, Attributable Audit Trail
Labeltrix ties every label it prints to the user who printed it and the exact date and time. For any batch, you can see who prepared the quarantine label, who drew and labelled the sample, and who issued the final approved label, along with when each step happened, giving your quality team a verifiable record for each label printed.
Built for 21 CFR Part 11 Compliance
Labeltrix is designed around 21 CFR Part 11, the regulatory standard for electronic records and signatures in the pharmaceutical industry, no unauthorised changes to records, and a clear trail of who did what, and when, at every step.
Every user gets an individual login, and Labeltrix captures every action, from creating a label template to printing a batch label, against that user with a date and time stamp. Templates are stored as masters, set up once, while every print and transaction is recorded individually, giving you a continuous, attributable history in place of a paper log book.
Labeltrix is a 21 CFR Part 11, cloud-based application on a subscription model, with validation documentation available to support your internal validation requirements. It is already in use with several pharmaceutical companies.
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