Case Study: Major Pharmaceutical Company achieves 21 CFR Part 11 compliance and streamlined, secure labeling with BarTender

Automated pharmaceutical label production increases accuracy and compliance while reducing risk

Major Pharmaceutical Company struggled with a highly manual, error-prone labeling process: operators managed more than 5,000 individual label files, shared templates by email, edited label files locally, and had no auditable controls or 21 CFR Part 11 compliance. To fix this, the company deployed the ROBAR enterprise label management system with BarTender labeling software integrated to centralize and secure label design and printing.

The solution centralized approved BarTender templates in a version-controlled database and moved printing to a browser-based workflow that merges validated variable data at print time. With BarTender integrated into ROBAR, the company reduced label administration from over 5,000 files to 60 templates, gained full audit trails and 21 CFR Part 11 electronic signature compliance, cut the potential for user error, accelerated enterprise-wide updates to seconds, and provided scalable serialization and traceability for global regulations.