Pharmaceuticals and Life Sciences Partner Solutions

ISA Consulting Validated Application Methodology

Pharmaceutical companies need the information to make critical R&D decisions earlier, reduce spending on failed compounds, and focus their companies’ resources on the best candidates for success. This situation has led to an industry-wide demand for business intelligence tools and technologies to improve decision making and business performance.

However, regulatory compliance concerns have often slowed the adoption of these technologies. In particular, the cost and complexity of software validation as required by the Federal Drug Administration (FDA) have caused reluctance among life sciences companies to upgrade software or adopt new technologies to improve business and clinical processes.

Software validation should not be seen as an added cost or burden. To the contrary, validation provides long-term savings in time, cost, and resources – because validation provides assurance that the software implementation will function as expected. Validation also brings the advantage of documentation that can reduce the cost and effort required to implement changes or remedy problems over time.

Cognos has partnered with ISA Consulting, a leading professional services firm specializing in business intelligence and data warehousing, to create a focused methodology to ensure a successful software validation process for Cognos business intelligence applications.

Benefits of the ISA Validated Application Methodology product include:

  • FDA-compliant documentation that the BI application will meet its specifications
  • Assurance that end users will have access to reports with accurate business intelligence
  • A high-quality Cognos BI application that will deliver value and results
  • Lower business risk
  • Lower cost of compliance.

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