Transforming healthcare IT: excellence in system validation & migration

The challenge

A Global Pharmaceutical Firm recently completed its spinoff of its Consumer Healthcare Division. This transition required replacing systems and infrastructure previously managed by the Pharmaceutical company.

The process involved replacing and updating 40 systems across 4 workstreams that were comprised of 55 servers and 424 workstations, Programmable Logic Controllers (PLCs), and assorted devices. Each system had to be disconnected from the existing Pharmaceutical Firm and reconfigured to operate independently on a stand-alone network within the new Consumer Healthcare Organization. This had to be completed before the agreed-upon exit date to avoid steep penalties.

The solution

We provided expert validation leadership for our client, guiding a local team of 27 plus an additional global team of 125 over a 2 year period. Utilizing the client’s Quality Management Methodology, we meticulously coordinated 2-3 months of pre-work before each planned facility shutdown, including the preparation of project plans , validation documents and system specifications in accordance with pharmaceutical laws and regulations. During four holiday shutdowns, our on-site team managed multiple system cutovers and orchestrated migrations tailored to specific business needs and IT systems. We conducted thorough dry-run testing during these shutdowns to verify the accuracy of qualification documents. Once testing was complete, we ensured that all reports were finalized and approved so that each system could return to production on-time.