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One of the most common projects that involves the widest range of issues to overcome can be the installation of an ERP system across a manufacturing site.
In this blog, we’ll discuss different challenges that can arise and how to overcome them.
A new, effective ERP/Accounting system needed to greatly decrease administrative labor hours, and greatly increase visibility and tracking of expenses.
Additionally, ISIS needed systems that could effectively manage today’s Enterprise Resource Planning (ERP) needs and support company growth well into the future, including manufacturing systems that were compliant with stringent FDA regulations.
This meant that manufacturing systems needed to be brought into a state of validation compliant with FDA regulations.
While at the time FMT had minimal experience with the actual validation process itself, they were still selected to partner with ISIS to produce the validation documentation, a laborious and detail-oriented project, primarily because FMT already knew the ISIS manufacturing process so well and ISIS trusted FMT with the ultimately successful validation effort.
By 2007, because ISIS was no longer manufacturing its drugs for commercial sale, its manufacturing processes had fallen out of an FDA validated state.
So in late 2008, ISIS determined it would begin an entirely new validation effort.
Our clients span from Discovery Phase organizations to Globally Mature companies.
In 2000, due to expanding business needs, ISIS initiated an even broader implementation under the direction of Beth Hougen, Vice President of Finance and Chief Accounting Officer. Hougen, the implementation went beautifully and according to plan, resulting in a fully integrated financial system that was entirely in the hands of ISIS to maintain.
In 2000, another essential business requirement for ISIS was to be able to manufacture commercial quantities of its lead drug.
FMT took on the project management role, providing a high-level plan and producing all the documentation including installation qualification, process qualification and user requirements.
By early 2009, the manufacturing system was again successfully brought into a validated state.