Top Clean Injection invests in Teklyx software

Top Clean Injection, a 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 its already implemented Codesoft label design software and 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, and trusted validation documentation providing confidence leading up to an audit.

Label Archive supports traceability requirements and patient safety needs. Both companies worked through the validation, which decreased the process from two weeks to just one and a half days after the implementation.

‘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 are validated.’