IT / OT Infrastructure Qualification and Operation in a GMP Environment
11-13 June 2025, Copenhagen, Denmark
Course No. 21759
Speakers
Dr. Bob McDowall
R.D. McDowall Ltd.
Yves Samson
Kereon
Frank Behnisch
CSL Behring
Note: All times mentioned are CEST.
Objectives
Get an overview of technologies discussed currently in the pharmaceutical environment
Learn what requirements are placed on the IT infrastructure and its qualification within the scope of GMP regulations
Principles outlined can be applied to Operation Technology (OT) for production systems
IT security and cybersecurity has now taken on a central role; here you will learn about the importance of the IT infrastructure in terms of an appropriate IT security concept
Case studies show you qualification approaches for key IT infrastructure components
Virtualization is a part of the IT infrastructure; learn strategies for qualifying the virtual machine and the virtualization platform
Background
In today’s pharmaceutical environment, the IT infrastructure is the backbone for the application of a wide range of software solutions. The requirements for IT security are becoming increasingly important. Only a robust IT infrastructure with suitable network topologies and security concepts can guarantee the appropriate security here.
Pharmaceutical regulations contain few or only indirect requirements for the IT infrastructure. The principles of the EU GMP guidelines state “The application should be validated, the IT infrastructure should be qualified”. Here the phrase “should” correspond to a “must”! Further information can be found in the revised version of the GAMP® Good Practice Guide “IT Infrastructure Control and Compliance” published in August 2017.
Target Group
The Event is aimed at managers from the pharmaceutical industry, suppliers and service companies who plan, qualify and operate IT infrastructure in a GxP Environment.
Applicable to all options: on premise / data hotel / SaaS IT
Regulatory and Legal Requirements / Agreement for IT/OT Infrastructure
GxP regulations with focus on Annex 11 and Chapter 7
Supplier assessment and agreements for IT suppliers: Risk management; Quality and technical agreements and service levels; Governance and Quality oversight; Time synchronisation
Brief summary of legal requirements: e.g. GDPR, HIPAA, etc.
Effective and efficient Compliance
Supporting life cycle model
Specification
Design
Verification
Workshop: “How can you ensure IT and QA work together?”
Although there needs to be quality oversight of IT operations and associated records, what is the best way for IT and Quality to collaborate? Suggestions made in the workshop will be discussed with the course attendees.
Content of an Agreement with an IT Service Provider
Annex 11 clause 3 requires that there is a formal agreement between an IT service provider and the business but provides little detail other the document should include clear statements of the responsibilities of the third party. What else is required in an IT agreement?
Scope of the IT services provided
Roles and responsibilities of both parties
Reporting with metrics against defined service Levels
Escalation pathway
Is an agreement for an internal IT department the same as a cloud service Provider?
Agile Infrastructure: Introduction to Infrastructure as Code (IaC)
Definition & scope
Toys or tool?: 40 years evolution
Flexibility & Agility: From installation to provisioning
The costs of Agility: Rigorous planning; Adequate tools; Training; Risks and benefits
Change and Configuration Management
Regulatory requirements
Definitions of change control and configuration management
Outline of a change management process
Security and Cybersecurity for a robust IT/OT Infrastructure
IT infrastructure security requirements
Cybersecurity: ransomware and malware
Sizing / Availability / Reliability
Basic security rules
Network topology
Network segregation
IT infrastructure monitoring
Recommendation for data archiving suppor
PEN testing
Incident and Problem Management
Definition of incident and problem
Incident investigation
Collating incidents into problems and their resolution
Linking with change control
Qualification Documentation
QP – Qualification Plan
TRS – Technical Requirements Specification
CS – Configuration Specifications
IQ – Installation Qualification a.k.a. Configuration Testing
Disaster Recovery Planning
Regulatory requirements for disaster recovery
For virtual and physical environment
Disaster recovery or business continuity plans?
Disaster recovery plan and testing
Order of application recovery with associated data
RPO – Recovery Point Objective
RTO – Recovery Time Objective
Workshop: Disaster Recovery Planning
Business continuity is an Annex 11 requirement. What should a disaster recover plan cover? How detailed should it be? What would be the triggers to activate a plan? How should it be tested? Does it need to be reviewed? If so how frequently? Could the same plan apply equally to an on-premises and cloud computerised system?
Design Review of IT Infrastructure
Design Review and Risk Management purpose
Performing Design Review
What might go wrong?
Critical review of the IT infrastructure
Design and monitoring of mitigation measures
Infrastructure as a Platform for Various Applications
Definition of Platform
Generic approach
Standard changes
Infrastructure lifecycle challenges for applications & GxP
Specialties in automation – challenge for infrastructure in 24/7 real-time applications
Case Study: Central Backup Management System
Requirements
Verification
Risk assessment
Configuration specification
Server / Agent / Operating parameters
Configuration Testing (IQ)
Functional Testing (OQ)
Supporting SOPs
Operation
Case Study: Firewall Qualification
Requirements
Risk assessment
Configuration specification
Configuration Testing (IQ)
Functional Testing (OQ)
Operation
This course is part of the GMP Certification Programme "ECA Certified Computer Validation Manager" Learn more
Testimonials
Seminar Programme as PDF