Imagine a short circuit triggers a fire in your building while you’re at work, and the smoke detector in your smart home fails to raise an alarm. Or you receive a notification that your bank account was compromised because the bank’s mobile application had experienced a cyber attack. Or the insulin-monitoring digital pill miscalculates your blood sugar and administers higher-than-needed levels of a drug. The ramifications can be severe. 

With digital technologies increasing the sophistication of consumer products and services, these offerings have become crucial to our day-to-day lives, and if they malfunction, they risk putting lives in jeopardy. The more consumers depend on digital products and services, the more essential it is to ensure they function as they should. This brings quality assurance (QA) to the front and center of everything enterprises do.

Success in digital now goes beyond customer experience, which could be a one-time thing; it’s now about trust – which is instilled by delivering a consistently enhanced and immersive customer experience, every time. And the way to assure trust is through impeccable quality that doesn’t go wrong – ever.

Assuring Trust: A Life Sciences Perspective

If trust issues can arise from a cyber attack on a mobile application, imagine what a trust deficit could mean for industries that have a direct bearing on human life, such as life sciences. Over 100,000 deaths are reported every year in the U.S. alone due to undisclosed or undiscovered drug side effects. Add to that the $38 billion paid in penalties by pharmaceutical firms from 1991 to 2017 for noncompliance.

These represent lapses in quality across life science functions in areas such as clinical trials, drug safety and pharmacovigilance. Moreover, the strides made by new digital capabilities such as telemedicine, digital platforms and mobile health make these lapses even more egregious – since patients are now more aware of and have far greater control over their own health management.

Ensuring trust requires a new approach to quality assurance. A recent Everest group report suggests a good start for life sciences organizations would be a renewed focus on patients and health outcomes. This would require industry players to rethink their priorities and operating models and collaborate with payers, providers, patient advocacy groups and digital healthcare platforms. By doing so, they can assure quality across patient journeys, from drug discovery to post-discharge follow-ups that ensure adherence to medication and treatment regimes.

As life sciences organizations focus on improving care outcomes for patients, QA needs to evolve into the role of custodian of quality management systems and orchestrator of audit readiness.

How QA Can Help Assure Trust

For any industry, putting customers front and center will help ensure quality not only at customer touchpoints but also across the customer journey. For this, QA needs to shift from an isolated function that occurs at the end of the product/service development workflow, to an ecosystem-driven model.  QA today needs to be defined by the following:

  • Domain-aligned. QA testing needs to take into account regulatory compliance and industry-specific business processes and concerns. QA professionals with knowledge of life sciences business processes and regulatory know-how can help organizations drive faster drug approvals by maintaining necessary documentation and keeping IT systems updated to adhere to patient-data safety regulations. 
  • Platform-led. With a platform-based QA model, enterprises can rapidly couple and decouple QA tools and solutions to address their specific needs. This is especially applicable to industries such as life sciences, which work with multiple solutions to drive a single outcome. For instance, a single shared investigation platform with standardized processes and protocols can accelerate clinical trials while reducing costs. 
  • Orchestrated. QA teams need the ability to collaborate with multiple partners beyond the organization’s boundaries, technologies and talent to support a shared inter- and intra-industry model. With an increasing number of players in the patient journey – such as payers, providers and digital healthcare organizations – the life sciences industry needs to orchestrate consistent quality throughout the ecosystem.

We’ve helped leading life sciences organizations assure trust by accelerating FDA approvals for their digital drugs, streamlining their clinical trials with a shared investigator platform and gaining visibility into post-sales customer service with a Salesforce-powered platform to better track and understand complaints, requests and feedback.

Increasingly, “trust” will be the main currency driving success for enterprises in a predominantly digital world, and this will require an unwavering focus on quality. Organizations can ensure trust by weaving QA into the core of their business processes and coordinating with ecosystem partners and digital platforms to shift toward a consumer-centric business model. In the end, businesses need to foster a community focused on quality – shifting the QA function to a central role in the enterprise.  

For more on this topic, see the Cognizant-Everest report, which describes how an orchestrated, platform-led QA capability can ensure the quality of data ecosystems, research and development, drugs and patient interactions, assuring trust in a converging life sciences ecosystem.

Navin Rao

Navin Rao

Navin Rao is Vice-President and Strategy Leader of the Quality Engineering & Assurance (QE&A) Practice within Cognizant Digital Systems and Technology. In... Read more