Client Synopsis
United States PharmacopeiaOrganisation Overview
The United States Pharmacopeia is a non-profit organisation that is responsible for establishing standards for medicines, dietary supplements and food ingredients in the United States. These standards are maintained in a compendium of drug information that is used by drug manufacturers and regulatory agencies to identify drug as well as establish their purity, strength, quality and consistency. In the United States, prescription medication and over-the-counter drugs must meet USP National Formulary (USP-NF) standards before they can be placed on the market as is mandated by federal law.
USP also works closely with USAID to help address critical issues relating to the availability of high quality medicines in more than 35 developing countries.
Fragile to Agile Engagement
Our engagement at USP was to establish the key foundations for an EA Practice as required to support their Standards Process Integration & Transformation (SPIT) project. Those foundations being the core EA artefacts, what we refer to as “EA the noun” and the core EA processes, what we refer to as “EA the verb”, specifically the governance processes required for EA to be successful.
The EA core artefacts (“EA the noun”) delivered by the engagement were:
- A Business Capability Model (BCM) of the areas of USP related to the Standards Production processes from the conception through a standards product becoming available;
- A high-level Logical Data Model, mapped to the BCM;
- A Business Capability Standardization Model to drive synergy and efficiency across those institutions;
- Reference Architectures: For the Integration, Data, Security and Business Process Design domains of design a diagram or document (for each) summarising the concepts in the domain and a set of principles for each containing the strategic outcomes supported, rationale and implications.
The EA core processes (and supporting bodies) delivered by the engagement were:
- Governance Board Charter/Terms of Reference – A document describing the terms of reference for the board(s), their roles and how they fit in the overall governance structure;
- Governance Processes – 3 Processes: vitality; review and exemption;
- Investment and Prioritization Roles & Responsibilities – describing the objectives, principles, roles and change types for the how to integrate recommended EA core processes into the existing process;
Investment and Prioritisation Process – diagrams and step descriptions, as needed, for this critical organisational process.