Label format consolidation and centralization in an FDA-regulated environment: A BarTender case study
agosto 07, 2019
By Elizabeth Sinclair, BarTender® senior manager of marketing
A pharmaceutical company administered, shared and printed over 5,000 individual label files. To print a product label at the company’s main plant, line operators browsed through server files and folders to find the correct label format by file name. The operator then opened the label design file in maintenance mode, manually entered data values such as lot and production numbers and expiration date directly on the label template, printed the label, and finally saved it as a new file in a folder on the local server. When a remote plant needed a label, administrators at the main facility sent it by email, and so the remote plant collected its own library of labels that were managed in the same way. With each new label, the number of individual files increased.
The system relied heavily on the expertise and accuracy of each user, and the lack of controls presented multiple windows for error. It required the creator of each new and updated label to store it in the correct place in the production folder, and it required each labeling operator to remember that location. Auditability was compromised by sharing files via email, with label files stored on local servers rather than in a central repository. There was also no protocol to ensure proper file backups were performed, and the system wasn’t scalable to future needs.
The pharmaceutical company contracted with a BarTender integrator to improve its labeling processes. All its label templates and data are now maintained separately in a secure, version-controlled database. Variable data fields such as lot number, expiration date and serial number are populated from external, validated sources at print time, instead of being individually keyed in by the print operator, who now easily initiates the label printing process through a forms-based print screen. The system merges the variable data with the appropriate, approved version of the label template, prints the label, and captures a comprehensive audit trail.
With BarTender, the company was able to reduce its 5,000 label files to just 60 label templates, which are automatically populated from a secure, auditable, central database of label content.
The pharmaceutical company is now agile in the face of changing business needs — BarTender's centralized file management means that label changes can be implemented across the enterprise in a matter of seconds. By making a change in a database field or the label template, instead of to individual labels, the change is applied to all relevant records and label templates. The newly streamlined and efficient processes are realizing cost savings for the company, and the built-in regulatory compliance structures are reducing corporate risk.
The new labeling processes are also scalable across the enterprise, and adaptable to meet future serialization, e-pedigree, and other traceability requirements as they are implemented.