Regulated environments


Regulated environments are areas in which the operations and products are subject of regulatory requirements, industry-imposed standards or policies of the parent company. This, off course, applies in more or less extend to every industry - for example, pharmaceuticals, waste processors and public transport companies.

A common misunderstanding that often occurs is that people think that a regulated environment is the same as a standardized environment. The opposite is true.
The rules adopted by the administration may indeed formulated very smart as "the sulfur content of fuel for ships must not exceed 0.1%."
In many cases, however, regulatory rules and requirements imply a certain principle - also called soft requirements or top requirements - rather than specific requirements for every situation and leave the practice and accountability to the entrepreneur. Through a mandatory audit the entrepreneur must prove that his business operations and production output meet these principles. Examples include FDA part 11 and EudraLex annex 11.
Contrary to what one might think is that the way to meet such rules requires a lot of flexibility from a MES package. The top requirements must be translated into specific requirements applicable to the particular part of the process or equipment. These specific requirements together with the objects and business logic form a unity and are generally purely specific to the production site , there is nothing standard to it.

As an example can be taken rule FDA 21 CFR 11:10 (f)  (Operational System Checks).
The rule says that FDA regulated computer systems should have 'sufficient controls or operational system checks to ensure that users must follow required procedures'.
This means that it must be determined at all points in the process flow where and what validations can and should be implemented. How these validations should take place and how the workflow is controlled further on the basis of the results of these validations.
An example is if a computer system regulates the release of a manufactured product for packaging, the computer system should not authorize the release until the appropriate quality approvals for production and intermediate storage has been provided.

So even in regulated environments flexibility in both data and business logic is a prerequisite. MESBuilder provides this. The modeling tool generates a overview of objects and business logic. Having these they can easily be linked to the specific requirements. From there it can be traced back to the top requirements. It makes that workflow can be verified and justified against the top requirements.