TEKLYNX
63 Case Studies
Case Study: Top Clean Injection achieves labeling compliance and validation with TEKLYNX LABEL ARCHIVE and VAP
A TEKLYNX Case Study
Top Clean Injection validates labeling in 1.5 days with TEKLYNX
Top Clean Injection, a medical device subcontractor, faced challenges in managing a manual, error-prone label approval process for over 1,000 labels across various products. This process, which relied on email and paper validations, needed to comply with stringent FDA and EU regulations, including 21 CFR Part 820 and ISO 13485. They turned to their long-time vendor, TEKLYNX, to standardize and validate their labeling system.
TEKLYNX implemented its LABEL ARCHIVE label management software alongside its Validation Accelerator Pack (VAP) to work with the existing CODESOFT solution. This provided Top Clean Injection with electronic approval workflows, full traceability, and pre-written validation documentation (IQ/OQ/PQ). As a result, TEKLYNX enabled the company to achieve full compliance and become audit-ready. The validation process, which was expected to take weeks, was completed by just two employees in only 1.5 days, saving significant time and resources.
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