Across the world, Russian ransomware attacks increased in 2021. Ransomware incidents in the US increased 82% from 2019 to 2021, and the US government is closing ranks with energy firms to guard against attacks. How does this affect pharmaceutical and medical device manufacturing?

cybersecurity and eqms

Medical devices face additional governance from the FDA.

Secure login and device access faces further scrutiny from the FDA. The top concerns for medical devices are:

    • Privileged access
    • Identification of cybersecurity vulnerabilities and incidents
    • Prevention and mitigation of cybersecurity vulnerabilities
    • Product lifecycle challenges and opportunities

Pharmaceutical and medical device manufacturing continues to operate according to general cybersecurity best practices.

  1. Update software – new updates may have additional security measures to protect against new threats and ransomware approaches.
  2. Avoid opening suspicious emails – protect against phishing scams and data breaches.
  3. Keep hardware up to date – Software updates may work better on new machines.
  4. Protect against unauthorized access – use a secure file sharing system, use secure logins, be sure to log out, etc.
  5. Train employees – practice cybersecurity to minimize susceptibility and vulnerability.
  6. Simplify – tracking updates to multiple software platforms and tracking training through various training methods can be complicated. Prevent gaps in training and tracking by simplifying and performing routine gap analyses.

How to protect your electronic quality management system

Your electronic quality management system (eQMS) is your pipeline. The PSC Software® family of eQMS and inspection management software includes the Adaptive Compliance Engine (ACE®) platform and AuditUtopia®.

  1. Update software – ACE® and AuditUtopia® have three updates per year. Every update is ready-to-use, GxP compliant, validated, and qualified.
  2. Secure access – ACE® and AuditUtopia® has configurable options to manage accounts via Single Sign On, Active Directory, OKTA, 2FA (two-factor authentication). Plus, ACE® and AuditUtopia® have tiered administrative access and role-based permissions restrictions.
  3. Secure storage – ACE® and AuditUtopia® are cloud-hosted via Amazon Web Services (AWS). By utilizing cloud-based software from a specialized hosting platform, you benefit from the teams of people working on cybersecurity for data storage and data access. AWS is compliant with many ISO standards for pharmaceutical and medical device industries, such as ISO 9001, ISO 27001, ISO 27017, and ISO 27018. Find out more about AWS cybersecurity here.
  4. Train employees – ACE® provides a structure for internal training documentation and tracking. Reduce the headache of tracing, tracking, and performing gap analysis for training on cybersecurity protocols with ACE®.

PSC Software® Solutions

PSC Software® is a trusted, industry-leading, cloud-native provider of quality management software specializing in pharmaceutical, medical device, and other regulated industries. PSC Software® is dedicated to cybersecurity and GxP compliance with the added goal to develop software that is intuitive to use, easy to learn, and flexible to fit each company’s needs.


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Contact us to find out more!

PSC Biotech® provides quality and compliance professionals for consultation on life science manufacturing. Check out PSC Biotech® for metrology, engineering, quality assurance, CQV services, and more!

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