September 4, 2025

Overview
A multinational pharmaceutical manufacturer reached out to Grantek for help at one of their overseas sites. This pharmaceutical manufacturer was facing an audit from the U.S. Food and Drug Administration (FDA) related to their production processes and overall building automation systems (BAS). Although the manufacturing facility being audited was outside of the United States, the products they produced could be sold into the American market, which made them subject to the FDA audit. After the audit, the FDA allowed a remediation period. Initially, the pharmaceutical manufacturer looked to a local vendor to deliver a remediation plan that would put them back in compliance with the FDA. However, that remediation plan was unable to stand up to scrutiny and time was running out. The pharmaceutical manufacturer knew if they missed the FDA deadline they would be unable to sell into the North American market. Frustrated with the cheaper and local vendors they had first engaged to no results, the pharmaceutical manufacturer reached out to Grantek to create a solution, in a now tight timeframe, that would ensure they were compliant with the DFA.

Challenges
Grantek began the engagement with the pharmaceutical manufacturer in a kick-off call held at the corporate level. With this being a multinational pharmaceutical manufacturer, the goal to implement a solution similar to what had been implemented at other sites in North America. The pharmaceutical manufacturer knew that type of solution, had and, would stand up to FDA audits. Grantek was able to demonstrate to the pharmaceutical manufacturer pervious experience improving production processes in North America, this created trust as Grantek embarked on remediating the issues at their overseas facility. The pharmaceutical manufacturer understood the value of reporting in a BAS system. In North America this reporting helped on each production shift on the plant floor, as well as management at the plant and enterprise level. The pharmaceutical manufacturer made the decision to implement a similar system at their overseas facility. This would also help overcome the FDA audit findings that needed to be corrected.

Solutions
The BAS solution Grantek provided allowed the pharmaceutical manufacturer to finally achieve consistency and verified reporting at their overseas facility. The pharmaceutical manufacturer now had visibility into operations with a standardized process. There was some initial apprehension about going beyond the local standards with a new BAS solutions, but it became clear that Grantek’s solution was actually more cost effective than the status quo. Although labor economics are different overseas, as opposed to North America, there are some things that more labor cannot fix. The BAS solution delivered by Grantek saved on overall production costs and drastically reduced downtime. More important than that, Grantek’s solution helped the pharmaceutical manufacturer pass their FDA audit. Furthermore, the impressive ROI and audit pass encouraged the pharmaceutical manufacturer to implement a similar BAS solution at their other overseas facilities, both greenfield and brownfield, as they came online.