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Labeling Software for
FDA 21 CFR Part 11 / GMP Annex 11

BarTender® software is the heart of FDA- and EC-validated labeling installations at medical device and pharmaceutical companies around the world. Systems ranging from complex, global enterprise-level integrations with ERP and PLM systems like SAP or Oracle, to smaller installations at growing companies, including nutraceutical firms, rely on BarTender to control labeling processes and change management in compliance with global record keeping and security regulations like 21 CFR Part 11 and GMP Annex 11.

BarTender is scalable to any system or regulation, and adaptable to the entire spectrum of AIDC technologies, including RFID.


BarTender and 21 CFR Part 11 / GMP Annex 11

Companies operating in regulated environments choose BarTender for its unparalleled security, label lifecycle management and serialization capabilities.

BarTender’s Administration Console, included in the Enterprise Automation edition, includes powerful security capabilities that can enable compliance with the most stringent regulatory requirement.

Centralized control

BarTender’s central file management capabilities enable changes to be implemented in a matter of seconds across the enterprise, and applied to all relevant records and label templates. Variable data such as lot number, expiration date and serial number can be shared. Use BarTender to administer label formats, catalog complete label lifecycle, and direct change management protocols centrally, whether labels are generated at one printer at a single location or at thousands of printers at facilities around the world.

Electronic signatures and data logging

BarTender’s electronic signature feature and comprehensive data logging capabilities combine to bring full audit trail accountability to the entire labeling process, from printing to label document versioning, enabling compliance with regulatory security standards.

Role-based access

BarTender offers a complete spectrum of configurable security options, ranging from simple Print-Only mode to complex role-based permissions: Control access to label design and modification, database setup, document saving, printing and more from a central location onsite — or at a facility on the other side of the world. Label format encryption can be applied to any of the security levels, providing an additional layer of protection against unauthorized use.


Which BarTender is right for you?

Select an edition below to learn more, or download the free 30-day trial to explore all of BarTender’s features and see how it can solve your toughest needs for labeling, barcoding and more. Or contact us to learn more about why BarTender is the most trusted software of its kind.

Create
(Design and Print)

Basic Edition

Professional Edition

Get started in just minutes!

All Basic features, plus:

  • Design and print labels, cards, mag stripe cards and more.
  • Optimize print speed to any printer or marking device.
  • Design data-entry forms that provide data validation and accept print-time input from the keyboard or a barcode scanner.

Licensed per PC

  • Read data from CSV files, databases and Excel. Easily search and select records for printing.
  • Encode RFID labels.

Licensed per PC

Create & Automate
(Design, Print and Control)

Automation Edition

Enterprise Automation Edition

All Professional features, plus:

All Automation features, plus:

  • Automatically print from any OS, system or device in response to data transactions and SDK requests.
  • Design using Intelligent TemplatesTM to reduce maintenance.
  • Secure the printing environment with user and group roles.
  • Monitor live print status and view detailed history of system usage.

Licensed per printer

  • Print from any iOS or Android device with the BarTender Print Portal App
  • Automatically print in response to Web service API or TCP/IP communication.
  • Integrate with SAP and Oracle.
  • Take advantage of centralized system management, browser-hosted printing, centralized template storage with revision control, electronic signature support, full SDK control, smart card encoding and more.

Licensed per printer

(Please note that Print Only editions have been discontinued as of BarTender 2016.)


About validating label software

Is BarTender validated for use in regulated environments? According to global regulatory agencies, it doesn’t need to be. Once integrated, BarTender is considered a piece of a larger software system, an enabling technology, and it’s that system that holds the validation, not its components. Here’s what you need to know:

  • BarTender is commercial off-the-shelf (COTS) software, an integrated component of a printing system.
  • BarTender is reliable, and currently deployed in regulated pharmaceutical and medical device environments around the world, including many FDA-validated systems.
  • BarTender is considered supporting software of a printing system. It is not an intrinsic component of a medical device, or a factor in safe medical device production, so it cannot carry individual compliance validation. BarTender receives validation through the certification of the larger printing system.
  • The guidance for software validation provided by most global regulatory agencies applies to products ranging from software that is in itself a medical device or a component of a medical device, to products that are used in the production and quality control of medical devices and pharmaceuticals. With the exception of certain specialized pharma applications, the processes that use BarTender are classified as such low risk to patients, that it does not require validation.
  • When a device manufacturer requires compliance testing, validation, and certification by a third-party auditor, it’s the integrator of the entire printing system that’s responsible for compliance, not the developer of an integrated component (that’s BarTender).

Related information

If you’d like to learn more about medical device software validation, start with International Technical Commission (IEC) 62304 — the validation standards of most countries are based on this document, which outlines development life cycle standards for medical software.

If you’re interested in the pharmaceutical industry’s validation standards, Good Automated Manufacturing Practice (GAMP), visit the International Society for Pharmaceutical Engineering (ISPE) GAMP resources page.

More information about validation in specific geographies can be found at their regulatory agencies’ websites: 


Industry Solution
Pharmaceutical labeling

BarTender® software is a secure component of validated installations at Pharmaceutical manufacturers and packagers around the world. Learn how the Pharma industry uses BarTender to meet global track and trace and serialization regulations.

Industry Solution
Medical device labeling

BarTender is the secure and trusted labeling software that adapts and scales to meet today’s global regulatory and business climate. Learn how BarTender helps medical device companies around the world streamline their supply chains and comply with Uniform Device Identification (UDI) rules.

White Paper
BarTender System Security

BarTender includes advanced security features that help protect your enterprise, data, and intellectual property while enabling compliance with global regulatory standards. Learn about BarTender and encryption, role-based access, electronic signatures, audit trails and more.

Case Study
Global, Multi-Facility 21 CFR Part 11-compliant Pharma Labeling

Read how BarTender transformed a highly manual set of labeling processes, increasing supply chain efficiencies and reducing exposure in a global, multi-facility, 21 CFR Part 11 pharmaceutical deployment.

Case Study
Global Centralization and SAP integration at Contract Packager Vetter Pharma

Vetter Pharma creates, prints and administers its labels directly from SAP. Learn how BarTender helped Vetter simplify their labeling system and meet global serialization requirements while maintaining GMP compliance.

More Information

Industry Solution
Pharmaceutical labeling

Industry Solution
Medical device labeling

White Paper
BarTender System Security

Case Study
Global, Multi-Facility 21 CFR Part 11-compliant Pharma Labeling

Case Study
Global Centralization and SAP integration at Contract Packager Vetter Pharma

BarTender Overview

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