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Quality Data & ROI ...



Quality Data for Clinical Submissions Means Return On Investment     posted 9/15/2009
Are quality-related efforts and quality control worth their costs? In light of an increased focus on quality and customer/client/regulatory agency satisfaction, pharmaceutical executive managers have raised the question: what is quality's return on investment {ROI}?

The answer to the question is fundamental: Quality must be measurable, preferably in dollars and a cause and effect relationship must exist between quality and financial results. Doing it right the first time and using quality-related efforts and quality control ensure the client with data that is fileable and accepted by regulatory agencies. Quality data allows fast track submissions, trust and integrity of data, shorter duration of regulatory review and a minimal number of questions concerning erroneous data.

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Quality-related efforts/quality control and ROI are linked to quality data and subsequently to:

  • corporate strategy and business planning
  • product development and commercialization
  • targeting and influencing the market
  • market and competitive intelligence.
Quality-related efforts/quality control and ROI ensure quality data, expert analysis and future forecasts that are subsequently linked to:
  • making more effective strategic and business decisions
  • accelerating delivery if product and commercial success
  • assessing and influencing your commercial and market
  • maintaining or obtaining critical competitive advantages
  • creating a faster review from regulators
  • limiting the doubts and questions of data without consistency and integrity.
The ROI outcome of using quality-related efforts and quality control can be realized in the savings of:
  • dollars
  • cost
  • value
  • time
  • the view of integrity and work {good/bad}.
It is important for a pharmaceutical company to realize that most of its quality-related efforts and quality control processes are not controlled. Once a pharmaceutical company has identified its key processes and established adequate process and quality control, quality is easily linked to financial performance and ROI.

Initially, most pharmaceutical executive managers relate the term "quality" to their products or services. Quality exceeds this narrow scope by far. Processes, systems, validations, quality control and quality assurance of data and documentation must also meet objectives or expectations. Only when a pharmaceutical company applies the quality concept to all processes, systems, validations, data and documentation and its entire management system it will then be able to see an ROI effect on its bottom line. Your pharmaceutical executive manager's team commitment to prevention principles determines your quality system's ROI.

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Commit to quality today. Realize ROI.