Featured White Paper
Life sciences industry and compliance are like Siamese twins - conjoined and inseparable. Non-compliance to industry regulations could wipe out the industry in totality. The authors suggest a unified IT compliance solution to stave off non-compliance related issues and thus reduce the cost of compliance.
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Healthcare applications are largely governed by provisions of regulatory standards such as 21 CFR Part 11. These requirements span through the lifecycle stages of software development. Validation activities contribute...
significantly to the overall cost of software development in the regulatory context due to implementation of additional controls required for regulatory compliance. This paper examines the current limitations of using the V-model for Regulatory Application Development and proposes an improved model to reduce time and cost of qualifications.
The life science industry and Healthcare Professionals (HCPs) have a symbiotic relationship. Information on patient needs and clinical data provided by HCPs are a guiding force to advance...
medical research. There are situations in which economic exchange between life sciences organizations and HCPs occur. Companies have established Fair Market Value guidelines to ensure that payments to HCPs are fair. This white paper outlines the challenges faced by the industry in ensuring HCP Spend compliance and explains how a reporting solution can increase reporting efficiency and improve validation and traceability of data changes.
While the financial upside is encouraging, the pitfalls of IT security are a significant deterrent in adopting the Shared Services Model (SSM). Shared services organizations are...
characterized by shared infrastructure, service-oriented organizational units, service groups working in silos, and overlapping responsibilities. They pose serious challenges to the adoption of an effective information security plan. Our expert explains that with the right amount of focus on IT security governance, adequate and timely training, appropriate Responsible, Accountable, Consulted, Informed (RACI) and Separation of Duties (SoD) matrices, and lean processes, the impact of these challenges can be significantly reduced.
Patent expirations, steep hike in prices, increasing therapeutic needs, and the emergence of biologics for drug development are the main drivers of research innovation in Life Science Industry. The need of the hour is to find new drugs in the quickest possible...
way. In spite of having the most advanced research techniques such as Genomics, Proteomics, Marker Based Assessment, and Microarray Technology at their finger tips, organizations find it difficult to actualize maximum research outcome. This white paper walks you through the various research challenges and ways to optimize the value of Research Informatics investments.
Soaring drug development costs, patent expiration and reduction in the number of blockbuster drugs are driving pharma companies to look at IT-enabled productivity. The traditional approach of 'working for business' is evolving into a 'working with business' model. Pharma...
IT processes must support this transformation and also manage mandatory regulatory requirements including the Food and Drug Administration's (FDA) Code of Federal Regulations (CFR) 21 Part 11 and Computer System Validation (CSV). In addition, IT process transformation must be able to deliver the right products and meet the needs of internal and external stakeholders.
Pharmaceutical companies are under pressure to speed up time-to-market and reduce costs for producing novel drug molecules. One of the key enablers to enhance productivity is grid computing. Grid allows linking up as many...
processors, storage and/or memory of distributed computers to make more efficient use of available computing resources. The benefits of grid computing include cost savings, faster time-to-market, enhanced collaboration and optimal use of existing computing resources. Infosys has developed Discovery Research Workflow on Grid (DRWG), a workflow solution to automate and accelerate gene discovery research. DRWG enables the user to customize a pipeline of compute intensive tasks, which can be executed on heterogeneous platforms. This paper discusses how high throughput functional annotation of genomic DNA sequences or profiling groups of protein sequences can leverage grid computing services.