Top Clean Injection, the subsidiary of Top Clean Packaging, is a medical device sub-contractor of approximately 250 products that must comply with FDA and EU requirements regarding quality management systems, software validation, and labeling control. By adding TEKLYNX LABEL ARCHIVE to their already implemented CODESOFT label design software plus the TEKLYNX VAP, or IQ/OQ/PQ documentation, Top Clean Injection established:
- Easy label approval workflows
- Full traceability of label creation and printing with audit trail
- Trusted validation documentation providing confidence leading up to an audit
LABEL ARCHIVE supports their label traceability requirements and patient safety needs. TEKLYNX worked through the validation of LABEL ARCHIVE with Top Clean Injection. What would have taken two weeks and multiple people only took two Top Clean Injection staff 1.5 days.
“We couldn’t have accomplished this level of label management and software validation without TEKLYNX,” said Elisabeth Tavard, Validation Manager at Top Clean Packaging. “It’s good to know we had labeling software experts from TEKLYNX to work with our validation and IT teams to prepare the documentation. Now, we’re completely confident in our label approval process and what we’ll present to customers and auditors to show how our label system and printing is validated.”
Download the case study to read the full customer success story.
TEKLYNX developed the TEKLYNX VAP as a direct result of Top Clean Injection and other consumer demand. Learn more at teklynx.com/validation-accelerator-pack.
About TEKLYNX International
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. 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.
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SOURCE TEKLYNX International