Standing up a TGA-approved pharmacy supplier business

The situation

InovaHealth was moving into pharmacy supply, a step that changes the regulatory footing of the whole business. Supplying therapeutic goods is not a matter of adding a product line. It means the technology, the records and the processes have to satisfy the Therapeutic Goods Administration, and be able to demonstrate that they do, on request. The existing systems had grown for a different business and could not carry that obligation.

Our approach

• Mapped the target operating model for a regulated pharmacy supplier back to the specific obligations it had to meet, so technology decisions followed compliance requirements rather than the other way around.
• Designed the process and system changes as a single piece of work — quality, traceability, record-keeping and access control built in from the start, not added after an audit asked for them.
• Delivered in short, visible cycles so the business could see the regulated processes take shape and correct course early.

What we delivered

• A target operating model for the pharmacy supplier business, with the regulatory obligations traced to the systems and processes that satisfy them.
• Dynamics 365 and Microsoft 365 configured for traceability, record-keeping and controlled access.
• Documented, TGA-aligned processes with the evidence trail assembled as the work happened.

Outcome

InovaHealth moved into pharmacy supply on technology and processes built to a TGA-approved standard, with the evidence to show it.