Computerised System Validation: Legacy Systems - Live Online Training
We offer you a discount of € 600 if you book this training course together with the course "Computerised System Validation: Maintaining Compliance during Operation"
Tuesday, 29 September 2026 9 .00 - 17.30 h
Course No. 22402
Speakers
Dr Robert Stephenson
Rob Stephenson Consultancy
Yves Samson
Kereon
Uwe Mai
Bayer
Highlights - Requirements for the qualification / validation of legacy systems - Legacy systems compliance from a QA perspective - Data integrity for legacy systems
We offer you a discount of € 600 if you book this training course together with the course "Computerised System Validation: Maintaining Compliance during Operation" from 30 September - 02 October 2026. Book both courses directly as a combination here.
Target Group
With experts from:
IT,
Quality Assurance,
Production / Quality Control,
Technology,
System Suppliers and Service Providers,
who have to maintain legacy systems and operate them in accordance with regulatory requirements.
Objectives
Can you still operate legacy systems, and if so, to what extent?
What can the auditor expect, and what solutions would be considered acceptable?
How can existing systems be specified retrospectively?
How can compliance be achieved from a QA perspective?
What can be done if important cybersecurity issues can no longer be technically controlled?
Programme
Query / Discussion - Problems / Expectations
Which systems are affected?
Why have these systems not been adequately qualified?
Retrospective qualification
Legacy Systems regulatory Requirements and Inspections
Old systems, legacy systems and existing non-compliant systems - characteristics and problems
Regulatory considerations
Annex 11 and Annex 15
PIC/S PI 011
GAMP GPG: The Validation of Legacy Systems
Inspection considerations
Legacy Systems: Ensuring Compliance from a QA Perspective
Legacy systems: IT security / virus protection / data protection
On-site infrastructure
System-side IT components
Qualification / validation of legacy IT systems
How to write URS for existing Systems
URS for existing systems: Waste of time or added value?
Why creating URS is easier for existing systems
Beyond the URS: the functional description
Case Studies: Contingency Planning / Support from the Manufacturer
What does risk-based Deployment mean for existing Systems?
Suitability for use
Learning from operational experience
Importance of periodic evaluation and its results
Quality efficiency
Old Systems, Legacy Systems and existing Systems = Data Integrity light?
Brief overview of the ALCOA++ principles
PIC/S PI 041-1: Data integrity
General problems: inadequate knowledge of the pharmaceutical process and data flow, lack of data definitions, non-existent definition of the GxP relevance of the generated data
Examples of problems with legacy systems and possible solutions
Missing audit trail functionality vs. necessity of an operational audit trail
Problems with user administration (no/too few users can be parameterized within the system)
Data management: ring memory, system data on USB sticks/SD cards > how to deal with this?
Further Information
Technical Information
We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical-information you will find all the information you Need to participate in our events and you can check if your System meets the necessary requirements to participate. If the Installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
Fees (per delegate, plus VAT)
Non-ECA Members EUR 1290.- ECA Members EUR 1090.- APIC Members EUR 1190.- (does not include ECA Membership) EU GMP Inspectorates EUR 645.- The conference fee is payable in advance after receipt of invoice.
We offer you a discount of € 600 if you book this training course together with the course "Maintaining Compliance during Operations" from 30 September - 02 October 2026 here.
Presentations/Certificate The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Conference language The official conference language will be English.
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