How life sciences can transform from doing digital to being digital has been saved
How life sciences can transform from doing digital to being digital
Enabling digitization with quality and 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
Define a digital strategy that aligns to business objectives and drives efficiency beyond basic compliance.
Digital health solutions
Set up a consistent approach to manage the quality and compliance of digital solutions.
Enterprise platform solutions
Leverage data analytics to mitigate privacy, security, and compliance risks of a cloud-first IT strategy.
Mergers & acquisitions
Strengthen M&A by integrating the right quality system elements from due diligence, carve outs to post transaction activities.
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.
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.
Build the capabilities—such as QMS and digital product development—necessary to help launch high-quality health tech products in an agile manner.
Align affected business systems and products with global digital health requirements for clinical evaluation, cybersecurity, and QMS.
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.
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.
Assist in creating a framework to consistently evaluate IT quality and compliance risks, then define mitigating controls across the M&A transaction life cycle.
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.
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.