Many organizations today struggle to manage their compliance requirements across multiple regulations, standards, and frameworks whether it is UDI, the MDR standards, GHS or other compliance initiatives.  We understand your business is complicated and that you are often required to implement a labeling system as mandated by your customers or a regulatory agency.  As part of our integrated compliance platform, we help ensure it fulfills the regulatory standards while maintaining business process efficiency.

The challenge:

The business challenge for organizations is to ensure that systems are in place to maintain compliance, mitigate risk and protect patient safety throughout the end-to-end labeling process, while ensuring cost-effective, efficient and profitable operations.

This requires cross-functional, organization-wide collaboration to assure that data formats, integration points and production infrastructure are all aligned – and are supported by a system that delivers that single source of the truth.

Our experience to date has indicated that our customers do not have the internal resources to accommodate the scope of the changes and the requirements. Their resources are spread thin across many projects and require our assistance to complete the compliance requirements on time. As such, Pragmatyxs has deployed resources to our customers to assist in the transition to these new platforms, to assist in the architecture of the solutions and in many instances, provide resources to convert labels to the new compliance formats.

Compliance labeling requirements like UDI or Title 21 CFR Part 11  can present challenges  to businesses in many forms. Most commonly these are from rigorous customer requirements or regulatory mandates. Regardless of the source, when faced with implementing a compliance labeling system, businesses need a complete enterprise solution that meets all of their needs.

We understand your business is complicated,  and now your required to implement a labeling system as mandated by your customers or a regulatory agency.  As part of our integrated compliance platform, we help ensure it fulfills the regulatory standards while also resolving any internal process issues.