TEKLYNX
31 Case Studies
Case Study: Top Clean Injection achieves complete compliance and validation with TEKLYNX LABEL ARCHIVE and CODESOFT
A TEKLYNX Case Study
Top Clean Injection Achieves Complete Compliance and Validation with LABEL ARCHIVE and IQ/OQ/PQ Documentation
Top Clean Injection, a medical device manufacturer and subsidiary of Top Clean Packaging, needed to standardize and validate its label approval process while meeting strict FDA, MDR, ISO 13485, and cleanroom requirements. Using TEKLYNX CODESOFT for label creation, the company was challenged by manual multi-step approvals, human error risk, and a lack of formal IQ/OQ/PQ validation for its highly regulated labeling environment.
TEKLYNX added LABEL ARCHIVE and the Validation Accelerator Pack to Top Clean Injection’s existing CODESOFT setup, creating a centralized, traceable, paperless label workflow with electronic approvals and validation documentation. As a result, Top Clean Injection became audit-ready and fully compliant, improved label control and WYSIWYG printing, and cut validation time from an expected two weeks to just 1.5 days with only two employees.
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Top Clean Injection
Elisabeth Tavard
Validation Manager