In addition, the pharmaceutical business naturally entails a significant degree of government regulation, including a certification process called validation that requires facilities handling drugs to be checked top to bottom, including people, processes and equipment, down to the hardware and software running the operation. Software must comply with regulations designed by the U.S. Food and Drug Administration to ensure that pharma and life sciences companies meet chain-of-custody and electronic records requirements that are as stringent as ink- and paper-based processes. For a WMS, that might mean ensuring a granular level of transactional and environmental visibility that provides an audit trail for each unit of a given drug.
Priority Solutions' other challenge as it prepared to deploy a WMS was that the company did not have a host inventory control or order management system in place to handle the pharma client's business at the new warehouse. Instead, the company was looking to the new warehouse management system to handle these processes. The IRMS solution from IWS included some capabilities that met these needs, but not exactly in the way that the pharmaceutical company wanted the system to function, according to Brown. "The challenge really was for us to define our requirement and couple that with figuring how to do it within the application itself," Brown says.
Benefiting from Partnership
Ordinarily Priority Solutions, like most companies, would have begun this supply chain technology project by gathering together its internal, cross-functional business and IT team to define its requirements before going out to the vendor community in search of a solution. But with time a pressing factor in the WMS implementation, Brown says that the company decided to bring in the recommended vendor, IWS, at the earliest stage of the project to assist in working through the requirements definition. "If you have the software supplier involved in the initial conversation around requirements, they can give you direction on what the base product can do and help you come up with a solution that will end up being more useful all around, and probably in less time," Brown explains.
The project team from Priority Solutions worked with a counterpart team of developers from IWS over the course of 18 months to clarify the requirements for the new system, implement the necessary changes in the WMS and get the warehouse management solution fine-tuned. Customizing software is never optimal, of course, but in this case both Priority Solutions and IWS were able to take a long-term view: by developing a solution that met the rigorous standards of one pharmaceutical client — and U.S. federal regulators — they would be able to offer their respective services and solutions to other customers in this industry with less effort.
"Our modifications were geared toward the client's requirements, but our plans were to become a 3PL provider in the Memphis area," Brown explains. "So we had one eye that was focused on the immediate need and the other eye focused on the future." Indeed, since completing the WMS deployment, Priority Solutions has added two additional pharma clients for the facility, essentially without any modifications to its system or processes. One new client had been forced out of its New Orleans facility by Hurricane Katrina but was able to get up and running doing retail shipments out of Priority Solutions' Memphis warehouse in a matter of days.
For its part, IWS switched from its rapid application development (RAD) methodology to a Good Automated Manufacturing Practice (GAMP4) methodology for managing the changes to its solution. GAMP4 is a commonly used process in the pharmaceutical industry for validating automated systems — what Carl Brewer, president of IWS, talks about as a sort of "ISO on steroids." In adopting the GAMP 4 methodology internally, IWS re-documented all its procedures "from floor to ceiling" for each discrete operation within its processes for developing source code and modifications, and then put systems in place to measure and monitor the code and changes so they could pass the very regimented FDA validation requirements. Documenting IWS' procedures provided a foundation for Priority Solutions to gain its "IQ OQ PQ" — Installation Qualifications, Operation Qualifications and Performance Qualifications — validation under the FDA regulations for the Memphis facility. But it also has allowed IWS to leverage its offering back into the pharmaceutical industry, including in the development of an emergency management and healthcare solution that now is being used to help protect 40 million Americans.