How life sciences can transform from doing digital to being digital

Introducing Deloitte’s Digital Quality & Compliance services

Strategic services

Define a digital strategy that aligns to business objectives and drives efficiency beyond basic compliance.

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Digital health solutions

Set up a consistent approach to manage the quality and compliance of digital solutions.

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Enterprise platform solutions

Leverage data analytics to mitigate privacy, security, and compliance risks of a cloud-first IT strategy.

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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.

Assessment and roadmap Transformation Organization change management

Assessment and roadmap

Establish a baseline of your current state capabilities and services, ways of working, and tech enablement; understand where you are compared to your peers; and assist in establishing an action-oriented roadmap and business case to help you modernize and transform your Quality and Compliance function

Transformation

Put the plan into action through implementation of agreed upon initiatives to help you refine the services you provide, how they are delivered, and how value is measured and communicated to the organization

Organization change management

Transform in a way that retains leading talent and creates a potential opportunity for your team to uplift how they engage with key stakeholders; also establish a change strategy that helps prepare the organization for what is new; and drive adoption

Digital health solutions

The digital health market is booming with solutions ranging from software as a medical device and clinical decision support software to general wellness apps. Each aim to lower costs, boost convenience, or improve patients’ health. How can organizations evaluate the quality of options and stand out from the crowd? We can help you set up a consistent approach to manage—and convey to stakeholders—the quality and compliance of your digital solution.

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.

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Implementation

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

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Remediation

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

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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.

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Mergers and Acquisitions (M&A)

Consolidation can help life sciences companies to fill product pipelines and expand to new markets. These transactions help acquiring companies to address a range of market shifts—from lower reimbursement to competition from generic manufacturers. But what if one or both sides of the transaction is without a cost-effective way to spin up digital quality resources to meet integration execution demand? Deloitte can help you with pre-transaction readiness to post-merger integration, while potentially strengthening data integrity program controls along the way.

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.

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Due diligence

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

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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.

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Managed Services

Digital Quality & Compliance computer system validation (CSV) capabilities

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

Future-focused digital quality & compliance management programs

• 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

Digital quality managed services features

• SDLC document review
• SDLC authoring
• SDLC consultation
• Periodic review
• Third-party audit