Setting the Standards at Health Level 7 (HL7)

Health Level 7 (HL7) is a standards development organization that is accredited by the American National Standards Institute (ANSI). A key goal of this organization is to create representation and communication requirements for health care related data. HL7 membership includes representatives such as vendors, health care providers, government agencies and others who have a common interest in the advancement of standards for administrative and clinical health care.

Regulated Product Submission (RPS) is an HL7 standard designed to facilitate the processing and review of regulated product information. GlobalSubmit has been at the forefront of RPS thought leadership. Jason Rock, CTO of GlobalSubmit provides an Overview of RPS on the FDA's website.

Even for experienced users, XML can be quite complicated. That’s why we recommend that you don’t create the RPS XML by hand. Instead, use your existing EDMS, software created by your internal team or vendor applications to build your XML. GlobalSubmit offers free X-Forms accessible from this website.