Life Sciences Expertise

Cybersecurity Services for Life Sciences Companies

Data in the Cloud Can Be 21 CFR Part 11 Compliant

Cyber attacks can be highly sophisticated or surprisingly simple. Either way, establishing and implementing cybersecurity controls is essential for prevention.

Life sciences companies are aiming to boost innovation, quality, and speed with digitalization, new and evolving technologies, and third-party providers. However, these solutions may also introduce cybersecurity vulnerabilities.

Security breaches target intellectual property and clinical trial data at life sciences companies and their third-party providers. The resulting harm can be significant. Managing these threats and risks is essential to technology and business strategies.

Read the white paper Cybersecurity Requirements for Medical Devices, which includes 9 steps to meet FD&C 524B requirements.

Mitigate Cybersecurity Threats with Services from USDM

IT Risk Assessments

The life sciences industry operates in a unique landscape. For example, risks and vulnerabilities must be identified and addressed at biopharma companies to ensure the security and integrity of their products. Assessing these risks helps to protect against disruptions that could have significant financial and reputational consequences.

USDM conducts a comprehensive risk assessment to identify vulnerabilities and potential threats specific to the biopharma industry. This helps determine the security posture of the company and highlights areas that require immediate attention. Cybersecurity maturity reviews check for adherence to standards, guidelines, and best practices such as CIS 18, the NIST Cybersecurity Framework, and ISO 27001.

Security Governance and Policies

Life sciences companies handle vast amounts of sensitive data, including patient information, clinical trial data, and intellectual property. The industry is also subject to stringent regulatory requirements, such as the Health Insurance Portability and Accountability Act (HIPAA) and U.S. Food and Drug Administration (FDA) regulations.

USDM develops and implements robust cybersecurity governance frameworks and policies tailored to the needs of biopharma companies. This includes defining security roles and responsibilities, establishing incident response procedures, and ensuring compliance with industry regulations.

Secure Infrastructure Design

Cyber threats challenge encryption, storage, and IT infrastructure. The potential for data breaches and unauthorized access continues to increase. Without proper design considerations, organizations may expose vulnerabilities in their networks, servers, databases, and cloud environments that malicious actors are waiting to exploit.

USDM helps design a secure and resilient IT infrastructure, including networks, servers, databases, and cloud environments. This involves implementing appropriate access controls, encryption mechanisms, and intrusion detection and prevention systems.

Data Protection and Privacy

There is an ever-present risk of data tampering, exposure, and manipulation. It’s important to protect sensitive information from loss due to theft or unauthorized access. Non-compliance with General Data Protection Regulation (GDPR) and HIPAA can lead to severe penalties, reputational damage, and legal consequences.

USDM provides guidance on protecting intellectual property, patient data, and other critical information. Solutions includes data encryption, access controls, secure data storage, and compliance with data protection regulations like GDPR and HIPAA. Ultimately, this promotes trust, maintains the reputation of the organization, and mitigates financial and legal risks associated with data breaches or non-compliance.

Incident Response and Recovery

Organizations face the constant threat of cybersecurity incidents. If not properly addressed, cyber attacks have the potential for significant financial, operational, and reputational impacts.

USDM develops incident response plans that provide support during security incidents and data breaches. They include timely detection, containment, investigation, and recovery to help minimize the impact and restore normal operations.

Vendor Risk Management

Many organizations rely on vendors and suppliers for various products and services, but these relationships can introduce potential vulnerabilities and cyber threats. It’s imperative that these third parties have effective security practices in place to protect sensitive information and systems.

By assessing and managing cybersecurity risks related to third-party vendors and suppliers, USDM helps to mitigate the potential threats. This involves evaluating the security practices of these entities, conducting due diligence to understand their cybersecurity capabilities, and establishing contractual obligations that enforce a high level of cybersecurity.

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’s 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.

Blog: Reducing Cybersecurity Risks

A primer for emerging life sciences firms

Cybersecurity Compliance Experts

With a strong track record in cybersecurity consulting, USDM 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 your progress and communicate it to your board of directors and auditors.
  • Respond to immediate threats, incidents, and breaches.

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

Virtual Chief Information Security Officer (vCISO) in Life Sciences

Whether you have a pre-IND startup, are an emerging life sciences firm, or run a well-established biopharma or medical device company, USDM vCISO options flex to your cybersecurity needs.

Brian Rankin, Head of Cybersecurity Services at USDM Life Sciences, has extensive experience developing and implementing security strategies that align with the business objectives of life sciences organizations. He has also served as a vCISO for several USDM clients. See an interview with Brian Rankin about vCISO for emerging biotech companies here.

Cybersecurity Threats and Risks 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.

Let's discuss your cybersecurity questions today.

Related Services

Data Integrity

Your data is the lifeblood and most valuable asset in your organization. How you access it, store it, move it, and back up and archive it, is all part of your data management and data integrity strategy.

GxP Cloud Platforms

Your success depends on how well you harness cloud technology to enable your teams to work from anywhere, build platforms that differentiate your company, and innovate faster. 

Quality Management

A well-designed quality management framework, when combined with manufacturing processes and product knowledge, supports increased safety and continuous process improvements.

Resources that might interest you

USDM Thought Leaders