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IT Quality Services for Life Sciences

Focused on life sciences digital quality and compliance

​In today's business environment, quality information technology (IT) is no longer just a "nice to have." Learn how our IT Quality Services can help your organization get more from its IT solutions, drive innovation, and mitigate IT risk.

The new risks in the next normal associated with COVID-19

  • Are new ways of working hampering or restricting your ability to execute your commitments related to digital (IT) quality and compliance?
  • Are you able to effectively conduct IT quality and compliance audits and assessments and associated remediation work remotely with your existing team?
  • Do you have concerns about data integrity within your organization resulting from COVID-19 or new ways of working?
  • Are you concerned about the state of compliance associated with third-party suppliers who provide your organization with regulated IT solutions? How has COVID-19 impacted their ability to remain qualified and compliant?
  • Are you struggling to find IT quality and compliance contracting support from suppliers or contractors who have experience and a proven track record of being able to effectively execute well remotely?

If you answered yes to any of these questions, Deloitte can help.
Our teams are helping many clients to maintain IT quality and compliance during these difficult times via our mature remote service delivery model. We are equipped to provide the assistance you need, when you need it.

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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 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 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 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

Get in touch

Srikanth Narayana Mangalam

Srikanth Narayana Mangalam

Managing Director | Deloitte & Touche LLP

Srikanth leads the Life Sciences Regulatory IT Quality practice with Deloitte Risk & Financial Advisory for Deloitte & Touche LLP. He has more than 15 years of experience providing regulatory and comp... More

John Conrad

John Conrad

Principal | Regulatory & Operations Risk

John is an Advisory principal in Regulatory & Operations Risk practice of Deloitte & Touche LLP. He advises his clients on numerous aspects of risk consulting, including assisting organizations in per... More

Joe Yacano

Joe Yacano

Associate Vice President | Deloitte & Touche LLP

Joe is an associate vice president with Deloitte Risk & Financial Advisory’s Managed Services & Products team within Deloitte & Touche LLP. Joe brings more than 20 years of industry experience and pro... More

Satyanarayana  Patloori (Pat)

Satyanarayana  Patloori (Pat)

Managing Director | Deloitte & Touche LLP

Pat is a managing director with Deloitte Risk & Financial Advisory for Deloitte & Touche LLP and has more than 15 years of experience in regulatory compliance concerning the manufacturing and distribu... More

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