Navigator Blog

All businesses want systems that perform as expected. But for life sciences companies, there is the additional burden of proving that the systems and processes within the company...

When food and beverage firms are small, it is often possible to get away with idiosyncratic or inconsistent processes that have been home-grown. But as a food and beverage...

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...

When a manufactured food is purchased by a consumer, there is the expectation that the food product is safe and consistent. This safety and consistency is important for the...

The life sciences are not like pens or bras. When a pen is manufactured incorrectly or suffers from shoddy inputs, a consumer just pulls out a different pen. When a life sciences...

Following good manufacturing practice (GMP) guidelines help businesses run more efficiently and ensure that product quality and consistency are maintained. Life sciences...

The life sciences is a heavily regulated industry for obvious reasons: the drugs and devices a life sciences firm manufactures or distributes must be consistently safe and...

ERP (Enterprise Resource Planning) software is a critical tool for businesses in many industries, including those that are regulated by the FDA. These software systems are...

The life science industry has to meet strict regulatory requirements in an extremely competitive environment burdened with financial pressures and unique market demands. Companies...

Strict process control is fundamental for life sciences businesses. Not only is it important for accurate manufacture of drugs and devices that can make the difference between...

ERP validation is a really simple idea: Does the system perform as specified?The question of validation is less about software functionality and largely about configuration. If a...

ERP validation sounds complex, but really it is simple: Does the software perform as specified?