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Modernizing Life Sciences with QSpace: The Digitization of IT quality and Compliance

Leveraging automation to transform IT quality validation

In today’s digital-first environment, many life sciences organizations are grappling with cost pressures, ineffective capabilities, and speed to market—while also struggling to meet stringent regulatory and compliance mandates. QSpace™, Deloitte’s IT quality computer system validation lifecycle management system, digitizes the end-to-end validation process to help you achieve stronger quality and compliance management.

Applying an IT quality validation process for greater value

Life sciences and health care organizations—specifically pharmaceuticals, medical devices, biotechnology, and consumer products organizations—need to comply with applicable regulations (clinical, research and development, manufacturing, inventory, sales, etc.) to help ensure patient safety, product quality, and data integrity. This means all processes, equipment, and supporting IT systems must be validated. But these pressures are compounded by manual processes that can—in turn—lead to added costs and resources, inefficiencies, and inaccurate data and documentation. In a highly regulated environment, these risks could lead to financial, legal, and operational penalties for organizations.

QSpace enables clients to digitize the end-to-end validation process for IT systems. This rapidly deployable cloud-based platform integrates a number of aspects of IT quality and compliance within a single risk-based platform. QSpace uses lean processes and system-induced controls to help reduce human errors and create enterprise-wide collaboration opportunities.

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QSpace is more than just a new technology solution

Our approach can increase value generation while lowering costs by focusing on:

People first: User-friendly design helps people onboard efficiently and perform to their potential
Quality and compliance at the speed of business: Compliance is digitally built-in, enabling teams to review systems faster and more efficiently
Quality by design, inherently GxP audit-compliance ready: QSpace provides quality results, instilling confidence in audit-ready data

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How does IT quality validation work with QSpace?

Our proprietary software is a multifaceted, in-depth validation tool that helps companies achieve IT quality confidence at speed, reducing the risk of non-compliance. To put it simply, it’s a process that automates the end-to-end validation process by integrating several aspects of IT quality into a single platform.

Other potential benefits include:
  • A single platform to automate an end-to-end validation process for all IT systems.
  • Digitization to enable increased efficiency, reduced cost, and enhanced reliability throughout the software development life cycle (SDLC).
  • A cloud-based platform for faster deployment to drive scalability and integration with other applications.
  • Powerful analytics with near real-time insights into critical performance indicators across the validation lifecycle to reduce the cost of compliance and increase efficiencies.
  • Compliance with FDA 21 CFR Part 11 and other global regulations, in which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records.

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Why Deloitte?

We have the team, experience, and knowledge to help your life sciences organization navigate through IT quality validation. We can help you define a clear, efficient, and cost-effective business strategy that can provide your company with a stable, scalable platform designed to support continued growth in an increasingly competitive life sciences market.

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Get in touch

Srikanth Narayana Mangalam

Srikanth Narayana Mangalam

Managing Director

Srikanth leads the Life Sciences Regulatory IT Quality practice with Deloitte Risk and Financial Advisory. He has more than 15 years of experience providing regulatory and compliance risk advisory ser... More

Durai Palani

Durai Palani

Vice President | Product Management

Durai is a vice president, Product Management with Deloitte Risk and Financial Advisory’s IT Quality team, brings more than 18 years of experience in Computerized Systems Validation (CSV), IT Quality,... More

Colleen Healy

Colleen Healy

Associate Vice President

Colleen is an associate vice president with Deloitte Risk and Financial Advisory’s Managed Services and Products team within Deloitte & Touche LLP. She brings more than 25 years of industry experience... More

Satyanarayana  Patloori (Pat)

Satyanarayana  Patloori (Pat)

Managing Director

Pat is a managing director with Deloitte Risk and Financial Advisory and has more than 15 years of experience in regulatory compliance concerning the manufacturing and distribution of both pharmaceuti... More

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