05.26.22
Teklynx International, a provider of enterprise label design and management solutions, has released a case study highlighting how their label security and traceability software, Label Archive, plus the Teklynx Validation Accelerator Pack (VAP) helped Top Clean Injection validate their labeling process in a fraction of the expected time.
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:
“We couldn’t have accomplished this level of label management and software validation without Teklynx,” says 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.”
Read the case study here.
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
“We couldn’t have accomplished this level of label management and software validation without Teklynx,” says 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.”
Read the case study here.
