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| As companies look to computer systems and models to facilitate the drug discovery and clinical testing process, it becomes imperative to ensure the validity of the underlying information sources and systems. The regulations provided by the Food and Drug Administration are designed to guide organizations in the development of computer systems that comply with industry best practices. It becomes critical that organizations develop a model that best functions within their financial and computing constraints. A formal Software Development Lifecycle (SDLC) is often used to drive compliance within an organization. Those interested in developing validated systems often use a third party that does not have a vested interest to minimize the possibility of conflicts of interest between development, testing and user groups. |
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| SCMS can provide support in the development and/or testing of your systems to facilitate the validation efforts of your organization. |
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| SCMS staff has worked with organizations to ensure compliance with FDA regulations by implementing a formal SDLC that incorporates a validation plan. We have seen many systems crippled under the weight of validation due to a lack of appropriate risk analysis. As such, a risk assessment is always conducted to ensure that only the necessary documentation and validation activities are conducted. |
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