Computer System Validation Training
Computer System Validation (CSV) is a core requirement for several industries. The aim of Computer System Validation is to ensure, through documentation, that the computer systems function the way they are intended to, consistently, repeatedly and reproducibly, somewhat in the manner expected of scientific experiments. So, the validation, meaning authentication or corroboration, is something that has to be done right from the start, that is, defining the computer system, to their use and going all the way right up to the time the computer system is retired.
Since it is in computer systems that crucial data relating to organizations doing any kind of business is stored; it is absolutely necessary for these organizations to ensure that all aspects of the computer systems, such as User Requirements Specifications and Hardware Requirements Specifications are validated, and that the recordkeeping requirements are complied with. These requirements are spelt out in regulations framed by the respective regulatory authorities.
The 21 CFR Part 11 In the US; Computer Systems Validation requirement is part of 21 CFR Part 11, which is mandated by the FDA. Apart from this, there are regulatory requirements for Computer Systems Validation from other regulatory bodies such as the ICH and Eudralex. No matter in which regulatory authority’s regulatory requirements an organization’s Computer Systems Validation is required to comply with; this is an activity that requires extensive and professional training. Professional training for Computer Systems Validation is a completely indispensable requirement, because in the absence of this kind of guidance; it is entirely possible for organizations to get their CSV wrong, the direct result of which is that they invite punitive actions from the respective regulatory authorities.
Getting their CSV right through the help of a professional training provider of repute, such as NetZealous LLC, a Fremont, CA-based provider of professional trainings in the areas of regulatory compliance, human resources, healthcare and IT, goes a long way in helping organizations get their CSV right.
Professional Computer Systems Validation trainings from NetZealous LLC Getting their CSV right is absolutely essential for organizations, as we have just examined. Getting it
right through the right trainings providers is even more so, because it is important to choose a professional provider that knows the ropes of Computer Systems Validation trainings. With its many years of being a reputable provider of professional trainings, NetZealous LLC is a preferred choice for thousands of regulatory professionals working around the globe.
Its panel of experts is chosen from a selection of the best names in the industry. They bring extensive experience that is drawn from long years of having worked in their respective industries.
Benefits of professional trainings from NetZealous LLC NetZealous LLC imparts professional trainings for all aspects of Computer Systems Validation. It imbibes risk based Computer Systems Validation processes into professionals with its trainings, which are made available in various modes such as web seminars, in-person live seminars and in-house trainings. With the variety of choices available for the learner; professionals can choose a mode of their choice.
In addition, NetZealous LLC has assembled experts from around the world, all of whom are highly renowned in their respective areas for the profound and insightful knowledge they bring about the subject. Any professional who wants to enroll for these trainings can rest assured that she will get some of the best trainings on Computer Systems Validation anywhere on the planet.
NetZealous LLC offers professional trainings on all aspects of Computer Systems Validation, including:
Basics of and jargon relating to Computer Systems Validation and risk management Complete understanding of the guidelines issued about Computer Systems Validation by the US FDA and other global regulatory agencies Thorough knowledge of spreadsheets, including an understanding of what they are, how and when they need to be validated, and a highly implementable idea of how to validate spreadsheets taking a risk based strategy Comprehensive knowledge of how to implement compliance requirements set out in 21 CFR Part 11
A full understanding of how to create and maintain documentation relating to validation for spreadsheets Understanding of the rationale behind FDA Warning Letters for improper creation and maintenance of spreadsheet A full explanation of the audit needed for software vendors.
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