What Is Regulatory Compliance?

Nancy B. Alston

The best route to understanding what regulatory compliance means is to go the root of the expression, which is clear. Compliance is described as a state of being in accordance with set regulations. So, regulatory compliance is simple -it is being compliant with regulations. Let us explore what kind of compliance is required, and what regulation are we talking about.

Regulatory compliance is an ocean:

In a broad sense, regulatory compliance is something whose depths can perhaps never be fathomed. This is so because everything -meaning quite literally everything from a pin to an airplane -needs some or another kind of compliance. Any product, from the smallest to the biggest, has to be compliant with regulatory requirements. What is it that makes regulatory compliance such a big thing, who frames rules and laws relating to regulation, and why is it so important?

Why is regulation needed?

This is as simple as why rules are needed for governing people. Every product from every field in the physical world, to quote the example given above again, from pin to an airplane, is manufactured and finessed according to set standards. These standards are needed because in their absence, there is no such thing as science in them. Science is all about exactness, logic and predictability.

In the absence of regulatory compliance, this very foundation is shaken. In other words, there is no product without regulatory compliance. All products have to go through demonstrable, deducible and reproducible processes. This is what makes them actual products. Or else, they would be some kind of spiritual experiment that is left to the individual to experience.

Regulation is at the heart of products and processes:

Any product that is manufactured, no matter to which field it belongs, has to undergo a clearly demonstrable process. The process has to be objective, and it must be open to changes and refutations. Only a product that convincingly demonstrates that it is capable of producing its desired effect time and again in any situation and at any point of time qualifies to be a process-oriented product. Regulations are all about making setting out specifications for these.

Further, if a product is to demonstrate its core quality, it has to also ensure that it is safe within prescribed limits. Who sets these prescribed limits? It is regulatory authorities again. So, regulatory compliance is all about ensuring that a product is just what it is and that it serves its intended use within set safety parameters.

Regulatory compliance and non-manufactured products:

Compliance is thus an area that is as vast as it is exact. Respective regulatory bodies exist in different countries at different levels to ensure that anything that is produced meets regulatory compliance standards. Having said this, we have to bear in mind that only manufactured products are subject to these hairsplitting, high-definition regulations. For instance, rice is produced, but is not manufactured.

Safety and intended use are the prime factors:

This is different from the case of say, medicines. All the processes, right from the ingredient stage, are precise and scientific. This is where we have to understand how regulatory compliance works. Eventually, the aim is to ascertain and ensure safety and intended use. Compliance is also needed to make sure that organizations making products are come out with safe products.

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