Get guidance for automated testing, IT change management, and artificial intelligence (AI) to decrease risk and increase operational efficiency.
What you'll learn
- How the session frames regulated IT system management challenges across the lifecycle of GxP systems—from initial rollout to decommissioning.
- What the experts discuss on CSV vs CSA and its impacts on IT and Quality teams.
- Best practices for automating IT change management, plus automating Validation Lifecycle Management (VLM).
- How test automation can speed up and simplify release management, and how periodic review automation is approached.
- How AI is applied for root cause analysis of GxP IT incidents, and how ProcessX and Cloud Assurance fit in.
Managing the lifecycle of GxP systems can be challenging for IT leaders at regulated life sciences companies. From initial rollout to decommissioning, they must ensure that the systems comply with FDA regulations like 21 CFR Part 11, Annex 11, and GxP requirements; that users are realizing value from the system; and that employees and customers are happy.
Imagine implementing automation in your organization for new ways of working while simplifying, scaling, and maintaining regulatory compliance. ProcessX and Cloud Assurance make it possible!
ProcessX automates regulated IT workflows like IT change management and enables an end-to-end holistic approach to Application Lifecycle Management (ALM). With real-time updates and total GxP system status transparency, IT and Quality leaders have peace of mind knowing that their systems are in a controlled state.
Achieve a new standard for digital quality across your organization by using modern cloud technologies to automate testing and validation and generating AI insights that support better business controls and outcomes.
In this on-demand webinar, we discuss:
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- Regulated IT system management challenges
- CSV vs CSA – Impacts on IT/Quality
- Best practices for automating IT Change Management
- Automating Validation Lifecycle Management (VLM)
- Test automation to speed up and simplify release management
- Periodic Review automation
- AI for root cause analysis of GxP IT Incidents
Check out this clip talking about the challenges with managing multiple IT systems in a GxP or non-GxP use case
Join our subject matter experts:
- Vega Finucan, Co-Founder & Managing Partner
- Jake Wright, Practice Director, ProcessX
Related USDM resources: Computer Software Assurance (CSA), USDM Cloud Assurance, 21 CFR Part 11 Compliance.
FAQ: Automate Now | Best Practices for GxP Systems
What does this on-demand session cover?
The session offers guidance for automated testing, IT change management, and artificial intelligence (AI) to decrease risk and increase operational efficiency. The experts discuss regulated IT system management challenges, CSV vs CSA and its impacts on IT/Quality, best practices for automating IT change management, automating Validation Lifecycle Management (VLM), test automation to speed up and simplify release management, periodic review automation, and AI for root cause analysis of GxP IT incidents.
Who should watch?
It's intended for IT leaders at regulated life sciences companies who manage the lifecycle of GxP systems from initial rollout to decommissioning, along with IT and Quality leaders who want to hear how automation, ProcessX, and Cloud Assurance are applied.
Who presents this session?
The USDM subject matter experts presenting are Vega Finucan, Co-Founder & Managing Partner, and Jake Wright, Practice Director, ProcessX.
How can I watch it?
This is an on-demand webinar you can watch any time using the player on this page. To request access or ask a question, contact us.
Where can I learn more from USDM?
You can explore related USDM resources, including Computer Software Assurance (CSA), USDM Cloud Assurance, and 21 CFR Part 11 Compliance.
Watch the on-demand session above, or contact us to learn more.