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Key Risk and Compliance Challenges Faced by the Life Sciences Sector

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Connected devices are fast becoming a vital part of the regulatory compliance landscape for the life sciences sector, as an astonishing amount of data is stored and shared between smaller and more mobile devices. Tracking the data shifting between these platforms and the various access points for consumers, patients or partners has caused an explosion of risk as human-machine interaction — often called Industry 4.0 — dramatically changes the business landscape. While the life sciences sector has lagged a bit in the adoption of these crossover devices, the speed of change is accelerating and causing significant grief to compliance professionals and security officers. Digitization of end-to-end processes, advanced collaboration and connected devices are all trends that are contributing to the transformation of the life sciences sector in the future.

Compliance Modernization

While regulatory compliance exists to ensure that companies all stay within the same guardrails and provide added protection for consumers, these compliance requirements can be a noted disadvantage for unprepared life sciences organizations. Modernization of the compliance systems allows the life sciences sector to maintain adequate compliance reporting and adherence without taking on a great deal of manual overhead. Introducing next-generation tools for compliance and reporting are helping life sciences entities meet the growing expectations of the market in a thoughtful way as opposed to scrambling to meet the latest challenges.

A few of the key compliance considerations include:

  • Electronic document and eSignature control, according to FDA 21 CFR Part 11.
  • File compliance and sharing, including version control and the creation of sophisticated audit trails as well as roles and permissions of individuals able to access the information.
  • Support for HIPAA and HITECH
  • Secure 3rd party relationships with CROs (Contract Research Organizations) and others, as well as protection for data at rest and in transit.

Collaboration with Industry Regulators

One positive trend in the life sciences sector is the increased collaboration between industry and regulators, providing proactive organizations with a way to bring their products to market more quickly than ever before. This push towards a joint approach to compliance and regulation is made possible by the maturation of software tools that offer active reporting that is flexible, vetted and well-trusted by industry regulators. It’s expected that this trend will continue as compliance requirements eventually become better understood and more formulaic for entities to adopt.

Data Breach Preparedness

Maintaining compliance requires a high degree of preparation for the digital future, and that includes a highly responsive cybersecurity strategy that can quickly adapt to protect against evolving threats. Hackers are continually becoming more advanced, launching attacks at unsuspecting personnel and utilizing social media to glean sensitive business details that can be used in phishing attacks. Each attack has the potential to bring ruin to a life sciences organization through lost revenue, reduced customer trust and the costs associated with remediation and communication efforts.

It’s not difficult to see the value of strict compliance in the life sciences sector. With the wealth of protected health information and competitive research, these organizations are a key target for cybercriminals. With increasing scrutiny from regulatory agencies, it’s vital that life sciences companies regularly review their risk profiles and create a heightened sense of urgency around compliance. The cybersecurity professionals at Coretelligent can work closely with your team to ensure you are fully up-to-date with the latest regulatory requirements, limiting risk and protecting digital assets. Contact Coretelligent today at 855-841-5888 or via email to to schedule your free initial consultation or to learn more about our core cybersecurity and regulatory compliance solutions.

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