About Aras Bilimsel Control
Aras Bilimsel Control has started from an idea. A goal. “Seeking for the smartification of every possible thing or process”. We don’t see limitations for our imagination in Aras Bilimsel Control group. We think of smartification and using artificial intelligent in anything. In any job that is dangerous for human, any method that helps human to do the work easier, faster and more precisely.
We seek for a safer, less troubling, and easier remote monitoring and controlling. We think of every situation in which it would be possible to use artificial intelligence for a better life and to reduce or eliminate the need for human’s presence.
We have entered different sections and aspects. By employing artificial intelligent, we have designed and introduced the highest intelligence in our projects.
Our scope of work starts from industries and producing lines to service, commercial and office buildings. One of the most valuable and advanced services has been implemented in the intelligent hospitals and luxury and super-luxury buildings.
We have combined novel methods and the best control technology with informatics-based methods and we have achieved the highest control efficiency.
We are proud to employ the latest equipment in the world with the highest quality, and with knowledge, capability and Iranian youth idea, have achieved the important goals of smartification in different parts of the world.
All of our large projects have become the most prominent and famous of their kind.
What is CSV in Software?
Before getting into the meaning of CSV, it’s crucial to understand how the Food & Drug Administration (FDA) and other regulatory bodies define computer systems. For starters, business managers need to broaden the scope of the term beyond a PC and the software suite installed on the device.
Computer systems include all the complementary equipment that supports the system as well as its users as a whole.
In software, CSV is perceived as a method that allows business managers to successfully complete the tasks a system was designed for, have control over user operations and their security, and be legally compliant.
Who Needs Computer System Validation?
Computer System Validation is more than a way to avoid profit loss and business risks. In certain instances, it can be life-saving.
For instance, detecting medication defects can prevent unfortunate side effects and avoid significant damage a drug consumer would’ve otherwise received.
That’s why CSV is an obligatory stage for some companies. Here’s the list of businesses that are legally enforced to conduct Computer System Validation.
Computer System Validation in the Pharma Industry
A pharma business manager needs to keep in mind that CSV is an industry standard accepted on the international level. In the US, the Food and Drug Administration is the main regulating and controlling body. It specifies computer system validation guidelines and monitors companies’ compliance with the norms.
For EU-based companies, validating the CSV software used by medical devices is a must as well. It is regulated and normed by the EudraLex Volume 4 — in particular, Annex 11 on Computerized Systems.
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