One area that sets the life sciences business apart from most other industries is system validation. Because life sciences products are a matter of public health, the processes that go into the creation of these products are carefully monitored and must be validated to meet regulatory standards. This is an extra burden that most other lines of business do not face, although financial service firms can relate.

Process and system validation is onerous but straightforward. The life sciences business must document and clearly show that all of its processes are defined and consistent, and that they meet regulatory requirements. This requires controls in place for process conformity, an ongoing audit trail, hefty process documentation and system validation from a third-party that verifies the processes function as described.

“The definition of software validation is that it is documented evidence that the system is installed and set up as intended,” says Archie O’Leary, vice president of sales for one of the leading life sciences validation firms, Arbour Group. “It is validation that the system operates as intended and that there are procedural controls in place for its use and that people are trained.”

Life Sciences firms can configure and document their ERP solution for validation, but that’s the hard way. The easier way is to start with a cloud ERP solution that comes preconfigured and ready for FDA validation.

Watch our Busting the Myths of FDA Validation webinar presented by Navigator and the Arbour Group

Prepackaged Cloud ERP for Faster Validation

Life sciences businesses face many similar needs, including system validation. As a leading ERP implementation partner in the life sciences space, we’ve developed a prepackaged SAP Cloud ERP solution for life sciences businesses that cuts down on the validation burden and creates faster system rollout.

Our tailored ERP solution comes preconfigured with the tools and standardized processes that most life sciences businesses need, with industry best practices baked in by default for an almost turnkey solution. This prepackaged industry solution comes ready to validate, greatly reducing the compliance headaches associated with setting up a new ERP for a life sciences business.

“I think prepackaged is the way to go,” notes O’Leary. “As any IT project manager would tell you, What are my risk and how do I reduce them? Well, prepackaged is certainly a way to reduce risks.”

Many third-party auditors also have experience with pre-packaged industry solutions such as ours, which further cuts cost by reducing validation time.

“We have pre-configured validation solutions for these systems,” says O’Leary. “We’ve done enough of them that we have a test-script library that represents the more prevalent functions in the manufacturing process for a life sciences company.”

Custom systems can be validated, of course. But that takes more time from an auditor.

“If we haven't seen it before, do we really care? No. But it's going to be expensive,” he says.

More than Just a Validation Accelerator

The burdens that life sciences businesses face extend beyond just validation, of course. Regulatory hurdles, stringent quality control demands, the increased use of CMO/CDMOs and the need for rapid innovation all require a powerful and adaptable cloud ERP system.

This is also where our SAP Cloud ERP solution for Life Sciences makes sense.

Effortless Outsourced Manufacturing: With the strength and flexibility of SAP Business Technology Platform (BTP), SAP Cloud ERP can seamlessly integrate with your CMO/CDMO outsourced manufacturing. These embedded contract manufacturing capabilities, when combined with real-time reporting and analytics, provide a clear 360-degree view of your business even when you outsource manufacturing, packaging, and distribution.

Uncompromising Quality: Integrate quality management processes throughout your operations through SAP Cloud ERP, with real-time visibility and robust batch tracking for enhanced product safety and risk mitigation.

Optimized Supply Chain: Manage sensitive materials and controlled substances with ease through our solution. SAP Cloud ERP provides advanced inventory and logistics tools to ensure the right products, the right quantities, and the right conditions at the right time.

Cloud-Based Agility: Scale your operations seamlessly with the flexible, cloud-based SAP infrastructure. Easily expand functionalities, add operating companies/groups, and integrate third-party systems as your business grows, without significant up-front investment.

Data-Driven Decisions: Leverage real-time insights from SAP Cloud ERP’s in-memory computing power and its system-wide AI capabilities. Make informed decisions backed by accurate data on financial performance, operational metrics, and market trends.

Faster Time to Market: Streamline project management, break down departmental silos, and ensure regulatory compliance at every stage with SAP Cloud ERP. Accelerate the introduction of new drugs, devices, or biotech products with end-to-end product lifecycle management.

ERP Rollout is Easier than You Think

With our prepackaged industry solution for life sciences business, cloud ERP rollout is a lot easier than you might imagine. By leveraging best practices and a pre-configured system, you can both cut down on validation headaches and implement a scalable cloud ERP solution in as little as 90 days.

Learn why life sciences businesses frequently choose us for ERP rollout. Contact one of our experienced ERP consultants by calling us at (801) 642-0123 or by writing info@nbs-us.com.