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Delivering success in a heavily regulated industry

When a startup progresses from idea to execution, particularly in industries that are riddled with regulations like pharmaceutical or food and beverage, we’ve learned to expect some bumps. Compliance with regulatory bodies, which is critical at every step in the production process, requires meticulous attention to detail (and can make you go gray, no pun intended).

The first challenge is that startups in these industries rarely have the internal production expertise needed to pull off a heavy lift. That's why partnering early on with a trusted integrator who has direct industry experience is a game changer—and that’s exactly what this pharmaceutical customer did when they hired us to bring their innovative product to life.  

Respected, referred, ready 

Our customer started out solo, selecting their technology platform: Siemens PLCs with Wonderware (now AVEVA) software for HMI, batching, and MES. They made an excellent choice, but they also knew that their expertise is in pharma, not control systems, so they contacted AVEVA for help. Since we’re known for our impressive track record of developing control solutions with AVEVA software, and we’ve worked with a number of medical industry customers, the AVEVA distributor recommended that the customer partner with us.

After meeting to demonstrate our experience in both technology and manufacturing, the pharmaceutical company knew we were the right partner to help them succeed.

We kicked off the project by listening carefully to their business goals and production and tech needs. Sounds simple, but too often providers march in with preconceived ideas before they fully understand the challenge. We view ourselves as a partner, not a provider, and we approach each project with curiosity instead of arrogance, letting the customer lead the story. 

Our mission boiled down to three primary objectives:  

  1. Translating needs into tangible technical requirements
  2. Reviewing and ensuring compliance with controls and automation systems
  3. Following appropriate architectures to satisfy every federal guideline, no matter how detailed or complex

Once we were aligned on program goals, our customer hired us to repeat our successful consulting process for the next phase: mapping out the functional specifications for the research/pilot batch system that we later got contracted to design. We then took the pilot line consultancy phase a step further by redefining what’s possible when you know how to harness the power of automation. For example, the customer’s quality team had initially planned to implement a paper-on-glass method for providing industry-required documentation. Instead, we demonstrated how modern technology could automate the whole shebang, saving them from tedious manual data entry and disastrous data collection errors. Automation’s true purpose is to keep things accurate, efficient, and timely—a clear benefit for any business.

Testing rewired, complexity unraveled

Armed with our pharmaceutical industry know-how and our extensive automation and controls experience, we guided the customer through the pilot line designed to meet their innovative product’s needs and navigate the maze of regulations they would face. As a starting point, we established software standards for the PLC/HMI, which are now implemented across the company.

In the land of precise (and endless) pharmaceutical regulations, before even a single line of code could be written, we had to dive into the theory of operation, something we’d prepped for in the consultancy phase as a precursor to executing software development. The master plan included using a building block architecture and following a Gantt model, which starts with user requirements, moves onto functional requirements, and then gets into the details. 

We also mapped out the test procedures, which involved testing backwards, starting with installation information, then functional testing, and finally performance testing against user requirements. It’s a dizzying and demanding exercise, but one where our Solutioneers shine. We built everything with this model in mind, skillfully crafting software test documents that allowed initial software tests to be reused in later regulatory testing. It’s all about maximizing efficiency.

Methodology matters 

We’ve developed a quality methodology for pharma that we tailor to each customer, ensuring top-notch software acceptance testing. At every step, we design, check, and employ independent quality analysis, and there’s no room for error or mediocrity.

Onto customer testing: we kicked things off by running the batching system in a simulated mode so we could test using a building block method. It’s not our style to cut corners, so we tested each device individually, along with sequences, and lastly, phases, orchestrated by the batch engine. Upon successful FAT completion, we had a software package primed and ready for action.   

The customer took the reins as general contractor when it came to field installation of the pilot, but our job wasn’t yet done. We assembled a comprehensive documentation package to ensure they were well-equipped to take ownership of the system.    

Always flexible

While the customer finished testing the pilot line, we wasted no time turning our attention back to the development of the production line. Another vendor was simultaneously working on the filling line, which created a challenge, but it was easy enough to flex and adapt our work to meet the customer’s needs. At their request, we developed the software for both the filling line and the comprehensive MES system. We started by helping our customer establish their requirements. Guided by industry standards, and coupled with our boots-on-the-ground experience, we designed the software for the discrete filling/packaging system and seamlessly integrated it with the MES layer. The line was designed with the capability to fill a single-component order using connections we developed with their ERP system.

Hardware and software design, quality assurance, developing test documentation, performing independent testing—this multifaceted project required extensive knowledge and resources, and our Solutioneers proved they were up for the challenge.