In this heavily regulated industry, compliance regulations require organizations to provide a sophisticated level of performance in their supply chains. Industry and compliance requirements (UDI), GUDID place significant demands on the efficiency of your organizational supply chain. With a proven record of experience in resources, products like Pragmatyxs PXSmartPrint and Pragmatyxs PXSmartLabel, Pragmatyxs can assist your organization in delivering validated, compliant solutions for barcode printing, validation, measurement, and audit of all label functions in your supply chain.
Your customers, regulators, and legislators expect the accuracy of label data, compliance with standards, and traceability for every product shipped, in accordance with FDA 21 CFR Part 11 requirements which require:
- All records for agency inspection and review.
- Secure authorized access with electronic signatures.
- Computer-generated audit trails.
- Record date and time of all modifications of electronic records.
- Document versioning and approval workflows.
- Traceability, visibility, and transparency of all labeling transactions across multiple locations.
Creating visibility into every step of the cycle strengthens the Enterprise global supply chain against possible counterfeit drugs or other counterfeit products, guarantees compliance with local and international regulations, and ultimately protects the health of the public and your business. Pragmatyxs’ integrated solutions provide assurance that you are compliant with all label requirements, provide security for your brand, and create scalable environments to match the needs of your expanding operations.
PXSmartDesign is Pragmatyxs’ label design service. Utilizing PXSmart Design will allow companies to augment their existing label design for new product roll-outs, label conversions, or complex labeling.
Regulatory compliance like the current need to modify labels to meet UDI standards and the risk of counterfeit products continues to be significant challenges to operations in life sciences, and mandates and compliance requirements drive the need for consistent accurate performance in all labeling environments, mediating the opportunity for counterfeit products.
With the trusted and knowledgeable team at Pragmatyxs we can:
- Improve Label Design
- Consolidate Label Templates
- Improve Label Quality
- Reduce Risk
- Increase Agility
- Mediate Counterfeit products