Rami Azulay

Rami Azulay

Whether you are a medical device vendor or function in another regulated field, the document control process is an essential part of successfully launching a product. You have the option of using an archaic filing system riddled with a minefield of human errors, or an automated electronic system. So if you are at the point where you are under a significant workload, and wish to have better compliance with the regulatory authorities, such as FDA, CE, it is time to consider an electronic document control management system, an e-DMS (Electronic Document Management System).

In this paper we are going to examine the quality of the event management process, and in particular
the CAPA, referred to as corrective and preventive action.
As we think about the quality management systems (QMS), and their different components, certainly
quality event management is one of the most important.
Additionally, as we look at the quality event management system more specifically, we see that it may
be broken up into primary components.

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Computer System Validation is the technical discipline that involves the use of life sciences companies, to ensure applications provide the information they were intended to. FDA monitoring and regulations evidence the need for strict quality measures, The Food and Drug Administration (FDA) which ensure specific controls and procedures during the Software Development Life Cycle (SDLC/ALM). Regulations such as those of the FDA also underscore the importance and need of not only following checks and procedures, but that these procedures are well documented. Said documents must be able to stand up to scrutiny by trained inspectors, especially since the financial penalties in the absence of an audit, can be exorbitant. Among the implications of not following relevant protocols in a Life Science Software application, include the loss of life. In applying the appropriate SDLC/ALM protocols such as documentation, are all part of the technical discipline of Computer System Validation. In effect, Computer System Validation involves what many IT people consider testing software.

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Quoting baseball player Yogi Berra who said, "If you do not know where you are going, you will wind up someplace else", Rami begins his discourse by pointing out that Berra's statement is true of Requirements. Rami continue that, many people are very aware of the impact Requirements managements has on programs. While this is so, he however is clear that this discussion is not about managing Requirements, but rather talking about writing the Requirement itself.

It is not how well one manages their Requirements. However, if one doesn't start with high quality Requirements, it really is not going to matter. It is therefore imperative to practice writing good Requirements, as these will have a great impact on your business.

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