TEKLYNX International Launches Validation Accelerator Pack to Simplify Validation Process of Labeling Solutions

Date: 03/22/2022 / Category: Press releases

The TEKLYNX Validation Accelerator Pack allows highly regulated companies to meet FDA and EU compliance requirements and accelerate validation with valuable templates

TEKLYNX International, known for its barcode labeling solutions that help highly regulated companies barcode better, today announces the launch of the TEKLYNX Validation Accelerator Pack (VAP). This offering allows companies to be audit-ready and meet United States Food & Drug Administration (FDA) and the European Union (EU) compliance requirements in medical device and life sciences labeling, plus save time and resources by accelerating the validation of labeling processes.

“Validating implemented labeling solutions is required for the medical device and life sciences industries, and we’re committed to helping companies in this space overcome regulatory challenges,” states Thierry Mauger, President of TEKLYNX International. “Our new TEKLYNX VAP offering provides our enterprise labeling customers with customizable validation templates to significantly decrease the amount of work and cost this process takes for validation teams.”

The TEKLYNX VAP is available for existing and new installations of CODESOFT plus LABEL ARCHIVE, label security and traceability software, or TEKLYNX CENTRAL, centralized label management solution. It includes the required testing procedures for validation and quality protocols, providing medical device manufacturers and life science companies with a tool to simplify and accelerate validation documentation and management:

• Installation Qualification (IQ) Protocols: Test protocol worksheets to guide and validate the computing prerequisites for correct installation of TEKLYNX software
• Operational Qualification (OQ) Protocols: Test protocol worksheets to guide and validate that TEKLYNX software operation is consistent with the user requirement specification
• Performance Qualification (PQ) Protocols: Test protocol worksheets to guide and validate TEKLYNX performance and alignment with customer requirements
• Validation Plan and Report: Templates to ensure validation activities are properly planned, reported, and completed in one primary document

TEKLYNX recommends highly regulated companies work with TEKLYNX Professional Services for label management deployment to help satisfy the documentation needs of IQ, OQ, and PQ validation packages, and to ensure the labeling system aligns with best practices.

Learn more at teklynx.com/validation-accelerator-pack or reach out to TEKLYNX in your region. You can also read our blog to get answers to the most common questions on the role of IQ, OQ, and PQ in labeling system verification and validation.

About TEKLYNX

TEKLYNX International helps supply chains work better. Today, more than 750,000 companies in over 170 countries trust TEKLYNX integrated barcode and RFID label design products and the people behind its solutions to make barcode labeling operations efficient, accurate, secure, and industry compliant. With over 30 years of experience, TEKLYNX is the global leader because of its reliable software and superior customer support. To learn more about how the TEKLYNX community helps companies across industries worldwide, visit teklynx.com or call TEKLYNX in your region. Barcode Better™ with TEKLYNX.