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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Mergers & acquisitions

Strengthen M&A by integrating the right quality system elements from due diligence, carve outs to post transaction activities.

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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.

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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Base business assistance

Maintain validated* digital health products via periodic reviews, supplier and vendor audits, corrective and preventative actions (CAPA) management assistance, and digital health regulations training.

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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.

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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Divestitures

Help migrate and remove applications along with associated quality systems elements as part of a divestiture while potentially alleviating the potential impact on the divesting company’s digital quality capabilities.

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Managed Services