Pharmaceutical
Navigate regulatory compliance with confidence
Prescribe a smart solution for your business.
BarTender helps you comply with the vast set of global track-and-trace regulations for prescription drugs and pharmaceutical products. With layered security, easy-to-use design tools, and intelligent templates, our versatile solutions help you easily manage the web of regulatory requirements, streamline your labeling workflow, and reduce the risk of human error.
Complete visibility with comprehensive security, auditing, and control
Complete visibility with comprehensive security, auditing, and control
Our labeling solution is familiar, even from the first time you open it. Our easy to learn, easy to use platform makes training your workforce simple.
BarTender is a powerful tool for even the most complex labels, in the most demanding regulatory environments.
Add accurate DSCSA, falsified medical directives and compliant GS1 barcodes with a simple drag and drop. The standards are built-in with each BarTender edition including over 95 different symbologies, including GS1’s linear and Data Matrix pharma barcodes and traditional linear, two-track, 2D and color Pharmacodes.
BarTender’s layered security features that range from basic print-only settings, to complex role-based permissions with label format encryption, give you configurable control over who can open, edit or print a label.
BarTender labeling software gives complete visibility into the labeling process — who accessed a label, what edits they made, where and when a label was printed. Capture e-signatures and complete audit trail for compliance with global regulations, including 21 CFR Part 11.
Be agile to meet changes in regulation, pricing or process with BarTender’s Intelligent Templates™. Edit a label’s data, format or design and updates will occur immediately throughout your organization. Your label is ready to print in real time, anywhere in the world it’s needed.
BarTender continually manages and monitors the serialization — unique, random or sequential — that drives your regulatory compliance, such as GS1 barcodes. Increment serial numbers at a single printer or at printers across your network.
BarTender labeling software aggregates identical data to pallet-level, case-level and unit-level formats to increase accuracy from pallet to product.
BarTender barcode software’s new, exclusive tables feature allows you to group a product’s IFU with its shipping and packaging labeling into one BarTender file to populate data from a single source.
Pharmaceutical regulations
BarTender labeling solutions provide comprehensive support for FDA 21 CFR Part 11 compliance by ensuring secure and accurate electronic records and signatures through robust validation and audit trail capabilities. With advanced security controls and user access management, BarTender helps companies maintain the integrity and authenticity of their labeling processes, meeting regulatory requirements effectively.
Secure and Accurate Electronic Records
BarTender ensures the integrity of electronic records through its robust data management capabilities. It allows for secure creation, modification, and storage of electronic records ensuring that they are accurate, complete, and reproducible in a legible format. BarTender incorporates advanced data validation checks and real-time monitoring to ensure data accuracy and compliance.
Robust Electronic Signatures
BarTender supports the use of electronic signatures and ensures that these signatures are uniquely attributable to a single individual, providing non-repudiation and ensuring that signatures cannot be easily falsified. BarTender also incorporates mechanisms for signing records, including password-protected access and multi-factor authentication.
Comprehensive Validation Process
BarTender’s validation process includes thorough testing and documentation to meet its intended use and regulatory requirements. BarTender provides tools and templates to help companies document their validation efforts, making it easier to demonstrate compliance.
Advanced Audit Trail Capabilities
BarTender includes built-in audit trail features that automatically capture and store detailed logs of all user actions related to electronic records. These audit trails are secure, time-stamped, and tamper-evident, providing a transparent and traceable record of all modifications, deletions, and access to records. This functionality is critical for maintaining compliance with FDA requirements and for conducting internal audits or investigations.
Enhanced Security and User Access Management
Implement stringent security measures to control user access and protect electronic records from unauthorized access or alterations. This includes role-based access control where users are assigned specific roles and permissions based on their responsibilities. BarTender also supports encryption and secure login protocols to further safeguard data integrity and confidentiality allowing for only authorized personnel to access and manage critical labeling information.
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