Regulatory Agencies have developed a set of expectations for companies who develop and operate computer systems in regulated spaces. Understanding how these policies are promulgated help will uncover the IT requirements that drive industry activities.
Very few people are aware that in the regulated space computing technology design, development, testing, and management are governed by laws, regulations, guidance, standards and funding priorities. VQS will make plain how governmental agencies help promulgate policies that aid in the acceptance of Cloud and Computerized systems and help you understand how the mismanagement of personal, private and confidential information in corporations and small offices could lead to court disputes, penalties, debarment, and imprisonment.
The federal government is not in the business of developing new technologies, but they are in the business of facilitating them. If you are planning to use computer-based products and services in a regulated industry or would like to gain a better grasp on how IT policies are promulgated, then I strongly suggest you consider VQS. In the United States the healthcare vertical, the integrity, privacy, and security of medical and health records are a prime directive. In the European computer space, personal privacy and data security are major factors that drive of cloud computing. This book will make plain the legislative spirit behind the enforcement of the regulations, policies, codes, rules, and standards.
Even though various agencies may echo similar definitions, it is important to understand those small distinctions governing each regulatory framework. VQS will make you aware of the stakeholders and policy shakers who provide funding and drive public policy towards the acceptance of cloud and computer networks.
The Office of Management and Budget (OBM) chartered the Infrastructure Optimization Initiative (IOI) in 2006. The goal of the (IOI) is to develop strategic infrastructure initiatives to operate and maintain IT infrastructure efficiently and effectively. The IOI helps government agencies understand the underlying performance metrics when determining the effectiveness of particular services being offered by service providers. IOI wanted to compile and post the parameters in a central location so that government agencies can pick various services that are aligned with their mission. These metrics will help them achieve optimum performance. Performance metrics such as response time, peak capacity, throughput, demand management, availability, and downtime are just some of IOI performance metrics needing more clarity.
Regulatory oversight is not just limited to ensuring validation of IT systems; it also includes jurisdiction over the data managed by these systems and management oversight of the system. The FDA monitors and regulates drug development processes around the world. Its role in the pre-clinical research stage (GLP) is not limited to evaluating data collected from research, but ensuring that the research was properly executed. This includes having oversight over detailed documentation that supports pre-clinical research and development. The FDA gives a favorable pre-clinical standing to companies who follow Good Laboratory Practices. Once a company finds sufficient evidence that a drug is successful when it is administered to animals, it will initiate human testing. Moving from an investigational new drug to testing in humans requires the efforts of professionals from many disciplines. Companies use GCPs when considering drug testing in humans. A new drug application can be filed with the FDA after multiple phases of clinical trials have been proven successful. Companies must demonstrate that a drug product is safe and effective. The product must also correlate with its purported quality. It must clearly demonstrate that it is paralleled to what is stated on the label. Lastly, it must be manufactured in an environment that utilizes good practices. Good Manufacturing practices described manufacturing techniques that are acceptable to the FDA. The pharmaceutical company must be able to demonstrate that the new drug product can be manufactured successfully. This includes proving that its computerized systems are functioning as intended.