The life sciences industry is unlike any other in that it is highly regulated and excruciatingly scrutinized for quality control. If an FDA audit uncovers questionable manufacturing practices at a pharmaceutical company, it could lead to fines, plant shut downs, drug recalls or at the very worst, incarceration of corporate executives.
Unfortunately, human error is often the cause of noncompliance. In fact, a primary reason many life science companies are issued an FDA Form 483 (which notifies the company’s management of objectionable conditions) is due to workers not following written procedure. Therefore, automated documentation of actions within every step—thereby designing human error out of the overall process—is key to overcoming mistakes that make compliance an issue.
That is exactly what Schneider Electric set out to do with its compliance driven delivery model that uses technology and a new methodology for building validation and quality control into the system design and manufacturing process.
The group’s approach includes awareness (educating key stakeholders about compliance driven delivery); assessment (of best practices at the facility); prioritization of action (risk management and ROI); and domain-focused delivery (based on the domain knowledge of Schneider Electric’s life sciences team.)
“We are bringing risk management, design review and change management all the way back to the requirements/design phase of a project so that the company can leverage everything that’s been done all the way through,” said Jonathon Thompson, Schneider Electric’s director of compliance consulting. “This is important because in the past we’ve approached [life science] projects the same way as food and beverage or other industries, where you go through the commissioning phase and then toss it over the fence to someone to validate. But they’d have to retest because it has not been done with documentation and compliance in mind.”
So Schneider switches this model around and appoints a compliance services manager, instead of a general project manager, to manage the project in order to drive the compliance methodology throughout every stage.
Having a person in charge who has domain expertise and an understanding of regulatory mandates ensures quality is driven throughout the project lifecycle.
“Compliance is often thought of as just validation and documentation. That’s part of it, but it is also about how that system is going to interact with the users and how the users are going to do things like creating electronic signatures and quality checks. These are things that people without domain knowledge may miss when it comes to how users will have to interact with the system. You have to think about this early in the design model,” Thompson said.
In this model there are other experts working under the compliance manager, including the solutions architect, the regulatory lead, the technical lead, the IT lead, the process lead and the change management lead. And all of these people become, in essence a virtual Center of Excellence (CoE) where models, process and controls are developed.
The CoE tests, validates and deploys to each site, building upon and adjusting what they’ve created within a central repository of templates that serves as a library of the process being developed. The repository is based on Wonderware System Platform with a layer above that for recipe models. It also utilizes the Skelta Business Process Management (BPM) technology to manage workflows, now an embedded part of the Wonderware solution offering.
According to David Mills, global life sciences solutions architect at Schneider Electric, workflow is an important piece of the compliance puzzle. An engineer may accidently export the wrong object to quality assurance. “But workflow can do the heavy lifting. It is all automatic and reduces the possibility of an error,” he said.
In addition, all of the accumulated engineering, testing and validation can be reused when rolling out new manufacturing environments, which reduces the amount of retesting. This saves a drug company time, money—and ultimately alleviates FDA headaches.