Running a life sciences business comes with all the needs and challenges of a typical business, but there also often are additional regulatory considerations. One of those considerations is Food and Drug Administration (FDA) systems validation.
Life sciences businesses that serve the U.S. market must prove that their systems engage in FDA-approved processes that meet FDA standards around quality, consistency, traceability and other requirements. While a shoe manufacturer can run backend operations any way it wants, a life sciences business does not have this luxury. A life sciences business must show proof that its operations follow FDA-approved practices, and this systems proof is called FDA validation.
There are two steps for FDA validation. First, a business must set up systems that conform to FDA process requirements. Second, these systems must be audited for the FDA so they show proof that they actually perform as specified and required.
FDA systems validation adds time and expense for a life sciences business. But businesses that approach their systems with validation in mind from the beginning can significantly reduce these costs.
One way that businesses can cut the cost of FDA validation is through the selection of a ready-to-validate cloud platform.
The Advantage of Ready-to-Validate Cloud Platforms
The idea is simple: Instead of building a system from scratch that meets validation requirements, a life sciences company instead uses a pre-build system that is already configured for FDA validation. This system is configured for the particular needs of the business, but at the same time it already conforms to the process requirements that will be checked during a validation audit.
There’s still the need to prove the system through validation, but correct setup will be faster and validation will be assured because the processes within the system are ready for validation by default. A ready-to-validate cloud platform is an off-the-shelf solution that already takes into account the requirements for FDA validation.
Pre-Configured ERP for Faster FDA Validation
An enterprise resource planning solution (ERP) is the cornerstone for operations at a life sciences business, whether this business is in the research and development stage, progressing through early-stage clinical trials, or working on scaling for full commercialization. ERP is the end-to-end business software that handles the various business functions of a company and unifies them for full visibility and coordination, much like the nervous system in the human body. These ERP solution platforms now typically are cloud-based.
FDA validation therefore largely is about the validation of the ERP system that a life sciences business uses for its operations. By using an ERP solution that is ready-to-validate, businesses can transform an onerous and particular regulatory headache into a legal formality. In the process, a life sciences business also can reduce the costs and speed up the rollout of its backend systems because the ERP solution is pre-build for the industry needs of the business.
One example of this advantage is the Center for Breakthrough Medicines (CBM), a contract development and manufacturing organization (CDMO) that helps expand access to critically needed cell and gene therapies.
In February, 2021, CBM selected and began implementing the SAP Business ByDesign ERP platform for its growing business in conjunction with help from Navigator and one of its ready-to-validate ERP solutions. By December of that year, CBM both had a commercialization-ready system and the FDA-required GMP validation that its line of business required (learn more about GMP validation).
“ERP systems are not known for going in quickly and effectively,” notes Joerg Ahlgrimm, CBM’s chief executive officer. “On the front it seems simple, but it’s very complex because there are so many integrated areas. If you don’t do it right, it can fall apart quickly.”
CBM was able to roll out its ERP solution quickly and get validation easily because it started with pre-configured ERP for life sciences manufacturing that required minimal configuration. It also helped that CBM worked with an implementation partner that understood FDA validation needs.
“We needed to be able to do this right the first time,” he notes. “With Navigator’s expertise, it worked out well. Navigator executed the work on time and on budget and has proven to be an invaluable partner in our corporate development.”
Take the Pain Out of FDA Systems Validation
Biotechnology, drug development firms, medical device manufacturers and other life sciences businesses turn to Navigator Business Solutions when they need rock-solid backend systems that roll out quickly and meet FDA validation requirements.
Navigator has developed prepackaged industry solutions that support many of today’s leading life sciences companies, and we are an SAP Gold Partner with experience rolling out more than 500 ERP implementations for businesses worldwide.
To learn more about how we can help your life sciences business, check out our validation services or contact one of our experienced ERP consultants at (801) 642-0123 or by writing us at info@nbs-us.com.
