A critical step in the serialization deployment process—the validation phase—has become a hot topic in the pharmaceutical industry. Pharma manufacturers are scrambling to assemble validation resources so they can meet the FDA’s DSCSA deadline, which requires them to serialize their products at the saleable-unit level by November 2018.
In doing so, pharma companies are discovering that the “self-validating” serialization software they thought they bought—including full validation support—is turning out to be a DIY product that resides on a multi-tenant platform (i.e., all customers share the same instance of the platform). The upshot is that any time the serialization provider updates its software, its clients must revalidate the system, which includes completing the critical, often complex regulatory documentation that shows the system has been tested and functions the way it’s supposed to function.
Recently, one of our competitors announced their launch of a new, automated validation product that attempts to fix shortfalls that currently exist in its multi-tenant serialization software.
At OPTEL, we offer a well-architected, flexible solution, with three environments for testing, validation and production. Our customers also maintain control over their updates. In addition, OPTEL is an avid proponent of automated testing; we run more than 5,800 unit tests and 3,400 functional tests nightly and growing. We also provide full validation documentation support for the core system and trading partner connections for the life of the service. Our platform features the most recent version of EPCIS and gives our clients the ability to update the system when they want to based on their specifications, internal resources, and timelines—not ours.
Our team of in-house quality and validation experts, led by former auditor Tim Donelon, strongly believe there is significant risk associated with a multi-tenant, one-size-fits-all approach. The reason is simple: you have much less control of your system.
“Your Quality group likely has a minimum requirement to follow a GAMP 5 approach for computer system validation,” Donelon says. “By using a system with a multi-tenant platform with bug fixes/updates that occur multiple times a week or every other week, you run the risk of not being able to maintain a validated state for your intended use. Further, connections among trading partners still require validation in order for serialization data to flow. Without proper change controls in place assessing the impact and risk, those connections are in jeopardy every time an update/bug fix occurs outside of your control.”