Implementing Compliant Systems in the Cloud
Description:
In this course, you will learn how to implement compliance systems in a cloud environment to meet FDA and European regulatory requirements. We will outline from a technical perspective the cloud and the different service models available. The different deployment models and their considerations for implementation in a GMP environment. The compliance challenges related to security, data integrity, visibility and control and the risk mitigation strategies to reduce or eliminate risk associated to security, data integrity and control.
Curriculum for this course:
Introduction
| Overview | 1 min 21 secs |
| Learning objectives | 2 mins 12 secs |
| Who should take this course? | 1 min 34 secs |
| Course modules | 1 min 36 secs |
Module 1: Technical Overview of the Cloud
| What is the cloud? | 1 min 23 secs |
| Three service models | 1 min 49 secs |
| Four deployment models | 1 min 23 secs |
| Application criticality | 2 mins 10 secs |
Module 2: Challenges and Risk Factors
| Challenges and risk factors associated with cloud systems | 1 min 20 secs |
| Data and security | 1 min 39 secs |
| Trust and reliability | 2 mins 10 secs |
| Security risk | 1 min 34 secs |
| Mitigation of risk | 2 mins 14 secs |
Module 3: Risk Mitigation Strategies for Cloud Based Systems
| Risk mitigation | 1 min 41 secs |
| Cloud components | 1 min 21 secs |
| Cloud control | 1 min 52 secs |
| Cloud policies for life science companies | 2 mins 12 secs |
| Cloud policies for service providers | 2 mins 10 secs |
| Supplier / vendor assessment | 2 mins 02 secs |
| Service level agreements | 2 mins 21 secs |
| Availability and performance | 3 mins 01 sec |
| Change management | 2 mins 31 secs |
| Quality of service | 1 min 34 secs |
| Security | 2 mins 10 secs |
| Business continuity | 2 mins 01 secs |
| Personnel qualification | 1 min 39 secs |
| Testing | 1 min 49 secs |
| Incident reporting & management | 1 min 30 secs |
| Documentation and information ownership | 1 min 21 secs |
| Performance monitoring | 1 min 32 secs |
| Alerts & escalation | 1 min 32 secs |
Module 4: Applying a Risk Based Validation Approach for Systems in the Cloud
| Risk Based Approach | 2 mins 01 sec |
| Avoid Duplication | 2 min 10 secs |
| Supplier Assessment | 1 min 30 secs |
| GxP Impact Assessment | 1 min 39 secs |
| 21 CFR Part 11 Assessment | 1 min 18 secs |
| Risk Assessment | 1 min 30 secs |
| Validation Plan | 2 mins 51 secs |
| User Requirement Specification | 1 min 49 secs |
| Installation Qualification | 2 mins 14 secs |
| Operational Qualification | 2 mins 01 secs |
| Performance Qualification | 1 min 30 secs |
| Validation Summary Report | 2 mins 10 secs |
| Conclusion | 1 min 41 secs |
Conclusion
Final Exam
Certification
Author:
General Info:
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CEU Credits: 0.1 -
Course code: ELM-118 -
Duration: 60 mins -
Skill Level: Intermediate -
Language: English -
Final Exam: Yes -
Certificate of Completion: Yes
Reviews:
Finally, a course that explains the complexity of going to the cloud in a regulated environment.
Loved the module on risk mitigation strategies, essential information when moving to the cloud.
This is a must do course for anyone validating software applications in the cloud.
Related courses:
Laboratory Data Integrity
Good Documentation Practices (GDocP) and Data Integrity
Managing and Ensuring Data Integrity of E-Records within a Regulated Environment
21 CFR Part 11 – 2003 Guidance
21 CFR Part 11 – An Introduction
21 CFR Part 11 – Electronic Records
21 CFR Part 11 – Electronic Signatures
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