IT Use in Regulated Industries
Explore the critical role of Information Technology in the life sciences industry, from foundational concepts of IT systems and networks to their applications in GMP-regulated environments like pharmaceuticals, biologics, and medical devices. Understand the integration of IT in manufacturing and quality operations, as well as in research and logistics. Delve into essential cybersecurity threats, protective measures, and regulations such as FDA’s 21 CFR Part 11. Learn best practices for computer and network security, data handling, and the use of encryption, audit trails, and firewalls to maintain compliance and safeguard sensitive information.
Whether for onboarding or annual refresher training, this Module is seamlessly deployable on any LMS and can be tailored to your company’s exact needs.
Duration: 30 Mins
Grade: Core Library
Description
- Understand the Role of IT Systems in Regulated Environments: Learn the fundamentals of IT systems, networks, and their applications to navigate technology effectively in regulated industries.
- Identify and Mitigate Cybersecurity Risks: Recognize threats such as viruses, ransomware, and phishing attacks while applying strategies to protect sensitive data and systems.
- Ensure Regulatory Compliance in IT Practices: Become familiar with regulations like FDA’s 21 CFR Part 11 to support secure electronic data management and compliance in daily operations.
- Apply IT Best Practices for Security: Learn practical methods for maintaining network security, safeguarding access credentials, and adhering to company policies on data handling and online activity.
- Strengthen Data Security Measures: Understand the role of encryption, audit trails, and secure information sharing in maintaining system integrity and regulatory compliance.
Learning Objectives
- Understand and be able to explain what is meant by the term “Information Technology”.
- Distinguish between computer software and computer hardware.
- Define computer network, LAN and WAN.
- Define Internet, e-mail, intranet, and World Wide Web.
- Describe the importance of computer security in regulated industries.
- Describe the various uses of IT in regulated industries.
- List and describe the rules for good computer practice.
Keywords
- Anti-virus software
- Audit trails
- Computer networks
- Cybersecurity
- Decryption
- Encryption
- FDA 21 CFR Part 11
- Firewall
- GMP-regulated industries
- Information Technology (IT)
- Phishing
- Ransomware
- Viruses
Module Features
Animations
Voice Over
Knowledge Checks
Assessments
SCORM/AICC compatible
Full Screen
