In this heavily regulated industry, compliance regulations require organizations to provide a sophisticated level of performance in their supply chains. In highly regulated environments, 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 and references in these compliance areas, 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 accuracy of label data, compliance with standards, and traceability for every product shipped, in accordance with FDA 21 CFR Part 11 requirements. It ensures you’ll withstand an FDA Part 11 audit and minimizes risks of production errors and product recalls.
- All records for agency inspection and review.
- Secure authorized access with electronic signatures.
- Computer generated audit trails.
- Record data 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 capabilities that are unique to your life sciences company, providing assurance that you are compliant with all label requirements, providing security for your brand and creating scalable environments to match the needs of your expanding operations.
PXSmartDesign is Pragmatyxs’ label design service. Utilizing PXSmart Design will allow companies to augment its 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 . Pragmatyxs’ experience and in-depth understanding of these label design tools make us the right choice for your product labeling needs.
Additionally, the risk of counterfeit products continues to be a significant risk to operations in life sciences, continued 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
Pragmatyxs will provide our considerable expertise to deliver the tools that reduce risk, provide compliance, produce and maintain a reliable audit trail with accessible data that you need to remain competitive in the life sciences marketplace.