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How life sciences can transform from doing digital to being digital

Enabling digitization with quality and compliance

How can we help you with your compliance?

When it comes to digitization in life sciences, a focus on quality and regulatory compliance is imperative. But the ever-changing regulatory landscape doesn’t have to be a roadblock. You can strengthen compliance with a risk-intelligent approach, harness insights and analytics to drive smarter decision-making, and set the stage for innovation with emerging digital technologies to achieve business objectives beyond compliance. Our Digital Quality & Compliance services provide an enterprise-wide set of solutions and services designed to help you achieve your goals and accelerate your digital quality maturity curve.

Introducing Deloitte’s Digital Quality & Compliance services

Strategic services

The struggle is visible. Life sciences companies are facing increasing pressure to personalize care, build virtual health, and manage costs—all while navigating through a maze of regulatory changes. To help address these pressures, more and more organizations are accelerating their digital strategies, but the challenge is how to accomplish this without cutting corners on risk management and compliance. Our Digital Quality & Compliance practice has developed a formula to help you move your organization forward and not only keep pace with business and IT, but become an accelerator to their strategy.

Enterprise platform solutions

As enterprise resource planning (ERP) systems move to the cloud, life sciences companies gain access to a new set of capabilities. In a regulated environment, cloud-based ERP systems bring a new set of issues around compliance, especially as they relate to Good Practices (GxP) quality guidelines. Moreover, as life sciences organizations use modern analytics capabilities to extract insights from a broad range of data, they need to understand a “Quality Data View,” which is key to driving accurate decisions. We can help you assess a third-party vendor’s controls against your company’s defined criteria and provide observations and recommendations. And we can help you identify potential risks associated with privacy, security, vendor’s controls, and compliance capabilities based on leading practices.

Managed Services

People

  • Industry experience
  • Regulatory knowledge
  • Scale and flexibility
  • Distinct talent hiring, development, and retention model

Process

  • Standard processes
  • Metrics (SLA/KPI)-driven services
  • Demonstrated client engagement and service delivery model

Technology

  • Technology-enabled delivery
  • Automation
  • Scalable and regulation compliant infrastructure
  • Cost predictability and potentially improved cost of operations
  • Agile and scalable delivery model
  • Benchmark risk processes against peers
  • Keep up with technology, regulatory, and business changes
  • Evolution to risk analytics and predictive risk capability
  • SDLC document review
  • SDLC authoring
  • SDLC consultation
  • Periodic review
  • Third-party audit
Assessment

Identify existing quality management system (QMS) and related capabilities for digital health products, evaluate them against industry standards, and then develop a plan for potential improvement.

Implementation

Build the capabilities—such as QMS and digital product development—necessary to help launch high-quality health tech products in an agile manner.

Remediation

Align affected business systems and products with global digital health requirements for clinical evaluation, cybersecurity, and QMS.

Strategy

Assist in creating a framework to consistently evaluate IT quality and compliance risks, then define mitigating controls across the M&A transaction life cycle.

Due diligence

Assess a target company’s QMS and other quality and compliance applications against the acquiring organization’s standards and industry leading practices.

Remediation and integration

Help close any IT quality and control gaps that come to light during due diligence, with an eye toward complete and accurate integration of data, processes, and technology.

Want to learn more about Digital Quality & Compliance services for life sciences?