Life sciences companies are leveraging digitalization, new and evolving technologies, and third-party providers to boost innovation, quality, and speed, but these compelling advances also introduce cybersecurity vulnerabilities.

Security breaches at life sciences companies and their third-party providers have targeted intellectual property and clinical trial data, and the resulting harm can be significant. Managing these threats and risks is an essential constituent of technology and business strategy.

Cybersecurity Compliance Regulations for Organizations of All Sizes

Even early-stage life sciences organizations generate valuable intellectual property, and stakes rapidly increase in the clinical and commercial phases. It is never too early to begin protecting yourself from cybersecurity threats and risks.

USDM has knowledgeable and experienced staff that will help you meet the U.S. Food and Drug Administration (FDA) expectations for good cybersecurity practices such as preventing unauthorized user access, ensuring trusted content, and maintaining data confidentiality.

Cybersecurity Compliance Experts

With our strong track record in cybersecurity consulting, we can help you:

  • Assess your current cybersecurity maturity level and provide actionable steps to close gaps and address vulnerabilities.
  • Evaluate security frameworks and select the one that is most appropriate for your business.
  • Set up an IT roadmap to achieve your security objectives and higher levels of self-sufficiency.
  • Assess and communicate your progress to your board of directors and auditors.
  • Respond to immediate threats, incidents, and breaches.

Read our Actionable Cybersecurity Roadmap for a Growing Pharma Company case study to learn how USDM helped a life sciences customer verify and mature their cybersecurity readiness.

Data Integrity in the Cloud

End to end risk assessments on GMP operations to identify and assess risk, determine controls, and create mitigation actions to reduce data integrity risk.

At USDM Life Sciences, we believe data integrity is a critical element of your quality system. We can assess your current data integrity system and provide a tailored improvement plan to build a data integrity program that fits with your company’s risks and priorities. This plan will address data integrity policies, training, and culture, and ensure that your quality system is fully integrated with best practice data integrity principles from supplier quality to internal audits to management review.

On-Demand Webinar

The drive to digitalization includes the need to increase automation, improve collaboration, and enable work-from-anywhere solutions. Here's a sneak peek of the cloud, mobile, and AI/ML technologies addressed in this webinar.

Click here to watch the full-length webinar,
Cybersecurity Threats and Risks to Life Sciences Companies.

 

Examples of How USDM Improves Data Integrity

Thought Leaders

Leading experts in every Life Sciences field.

Learn More
Bob Lucchesi
Bob Lucchesi

Vice President of Global Regulatory Compliance, Quality Assurance and Auditing

Jay Crowley
Jay Crowley

Vice President of Medical Device Solutions and Services

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