IT Quality Services for Life Sciences

Using life sciences information technology to accelerate innovation

Life sciences companies are demanding more from their information technology solutions to accelerate development and innovation, better serve customers and patients, and reduce costs. Compounding these pressures is the requirement for regulatory compliance from the US Food and Drug Administration (FDA) where FDA guidance encourages a risk-intelligent approach to life sciences information technology. To move at the speed of business, IT quality is no longer a "nice to have" but a business-critical initiative.

Deloitte's IT Quality practice helps life sciences companies meet their needs for effective, efficient, and compliant IT quality services—from strategy and implementation to management.

Our portfolio of solutions helps establish an agile, responsive, and cost-effective program that unifies computer system validation (CSV) and overall business strategy while providing the continuity, knowledge, and discipline required to satisfy regulatory pressures.

This includes:

• Advise solutions: Includes IT optimization assessments, IT strategy, standard operating procedures (SOP) development and review, mock FDA inspection/training, and mergers & acquisitions due diligence
• Medical device safety and security solutions: Includes risk assessments, product security, and Good X Practice (GxP)-compliant technology design, development, and implementation
• Build solutions: Assists clients with the deployment of platforms and software in a GxP environment (includes cloud, SAS, MedTech, and legacy environments)
• Managed Risk Services: Leverages Deloitte's distinct operating platform and delivery model to provide end-to-end services including continuous validation of systems and software, operational oversight of corrective and preventive actions (CAPA) management, external inspection readiness, periodic review, and IT compliance audits

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Is it time for a new approach to IT quality?

A few questions to consider:

• Do our business leaders view IT quality as making a positive contribution to the organization's strategic objectives?
• Do we have the full range of skills needed to support innovative efforts?
• Are we able to cost-effectively meet regulatory expectations?
• Are we able to scale up or down to address CSV requirements without incurring excess costs?
• Are we able to maintain consistency and continuity?
• Can we demonstrate the effectiveness of our quality efforts against industry benchmarks?

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Moving at the speed of business

Leveraging Deloitte's distinct Managed Risk Services, our IT Quality solution brings together an efficient alignment of leading people and processes and a technology-enabled platform to help organizations modernize the IT business, boost performance, and accelerate adoption and deployment throughout the full software development life cycle (SDLC). These valuable, output-based solutions offer predictable pricing and span IT Quality Advise and Managed Risk Services backed by enabling technologies and analytics.

By adopting an enterprise-wide program designed to effectively manage risk, decrease costs, and help achieve global health authority (e.g., FDA, EMA, PMDA) regulatory compliance, companies can focus on customer- and patient-centric innovations that strategically move their businesses forward.

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Key features of our solution

• Annualized planning, management, and coordination of periodic and project-based initiatives
• Global coverage and the ability to scale
• Predictable unit- and outcome-based pricing
• Standardized assessment methods and processes, incorporating the latest industry standards and leading practices developed by Deloitte's CSV Center of Excellence
• Key performance indicator (KPI)-based quality reporting and metrics, informed by industry benchmarks
• Access to complementary services to fulfill specialized requirements on an as-needed basis

Contact us to learn more.

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