Life Sciences Validation and Testing Practice
Apart from addressing diminishing product pipelines and stagnant top line revenues, life sciences companies also face challenges in:
- Regulatory environment: Compliance with Good Automated Manufacturing Practice (GAMP), 21 CFR Part 11, etc. The Food and Drug Administration (FDA) is getting increasingly conservative about approvals and may make it mandatory to undertake further research before approvals.
- Operations: Deal with mergers and acquisitions, limited financing options, patents nearing expiration, expanded product portfolios, etc.
- Technology: Leverage IT to reduce time-to-market, enable growth in e-submissions and ensure mandatory e-submission of product labeling data
Infosys' Life Sciences Validation and Testing Practice helps companies address the changing regulatory landscape and gain a competitive advantage.
The Infosys Advantage
- Reusable Test Methodology Framework for developing test cases meets 21 CFR Part 11 requirements. It reduces the cost of regulatory compliance as well as citations for non-compliance during FDA audits.
- Pre-built business process models and test case parameterization technique reduce planning effort and accelerate time-to-market
- End-to-end test automation in a validated environment helps reduce manual intervention, defects in the production environment and disruption to business
- Accelerated off-the-shelf Quality Assurance (QA) implementation combines with Infosys Integrated Test Accelerator suite to reduce Total Cost of Ownership
- Reusable test suite for Laboratory Information Management System (LIMS)
- Customization of HP Quality Center with E-signature accelerator and Infosys Test Automation Accelerator (ITAA) accelerates time-to-market and release/ project throughput
- Unified approach covering people, processes and technology at the enterprise level ensures continuous improvement
- Risk Based Testing (RBT) assures process compliance and quality of testing
Learn more about our offerings for the life sciences industry and our other testing services and solutions