Computer Software Assurance - CSA - Live Online Training
Wednesday, 10 February 2027 9 .00 - 17.00 h
Course No. 23271
Speakers
Eberhard Kwiatkowski
PharmAdvantageIT
Stefan Münch
Körber Pharma Consulting
Yves Samson
Kereon
Does CSA lead to changes during the validation of computerised systems? - Opportunities and limitations in the pharmaceutical industry.
Target Group
Staff from the Life Sciences Business (pharmaceuticals / medical devices / suppliers / consultancy) in the following areas:
IT
Quality Assurance
Manufacturing
Quality Control
Objectives
Why should you attend this event?
The background to the FDA’s CSA (Computer Software Assurance) initiative will be presented
Does CSA replace CSV? You will learn about the connections and differences between CSV (Computerised System Validation) and CSA
What benefits does CSA offer for software validation?
CSA is the result of an initiative by the life sciences industry and the FDA to promote a risk-based approach that focuses more strongly on software quality while significantly reducing the documentation burden. Following an initial draft in 2022, the FDA published the final version on 3 February 2026.
Programme
Background / Application to Medical Devices / Applicable to Pharmaceuticals?
Medical devices vs pharmaceutical GxP
European Union
USA
2017–2026: CSA development. From the triggers to the final version (February 2026)
Differences in context between medical devices and pharmaceutical applications and devices
CSA Risk Framework
Identifying the Intended Use
When is validation necessary?
Risk-based scaling
Procedure for using the cloud
Determining the Risk-Based Approach
Risk-based approach according to ISO 13485
Comparison with ISO 14971
Identification of risks in software applications
Binary or spectrum – which is it?
Production of Quality System Software Changes
How much validation evidence is needed?
Defined user requirements
Validation of off-the-shelf software and automated equipment
Validated according to a written procedure for the particular intended use
Determining the Appropriate Activities
From specifications to testing
50 shades of testing
Additional Considerations for Assurance Activities
Activities and established processes that provide control in production
Additional process controls, including activities to reduce cybersecurity exposure
The data and information collected periodically or continuously by the software
The use of tools supporting software development and system life cycle activities
The use of testing and results carried out in iterative cycles
Establishing the Appropriate Records
How much quality assurance documentation is required?
Effective use of digital resources
Considerations for Electronic Records Requirements
When does 21 CFR Part 11 apply?
Which records are affected under 21 CFR Part 820?
How do I explain this to the regulatory authority?
Examples:
Example 1: Nonconformance Management System
Standard (off-the-shelf) systems and the effective use of supplier involvement
What is expected / what should be done?
Example 2: Learning Management System (LMS)
Learning Management System (LMS) applying a risk-based approach
Established SOP for evaluating suppliers
Developing a risk-based assurance strategy
CSV vs. CSA – Relationship to other Regulations
Clarification of terms
CSV vs. CSA – Key differences
Relationship to other regulations (ISO standard environment)
Assessment – What is Good, Useful, Unsuitable
Critical thinking: The CSA’s ‘poltergeist’
Optimising compliance activities
Focus on what is truly relevant and necessary
A computer-based system is not the same as computer software
What about quality control equipment and production facilities?
Further Information
Technical Requirements
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)
ECA Members EUR 1,090 APIC Members EUR 1,190 Non-ECA Members EUR 1,290 EU GMP Inspectorates EUR 645 The conference fee is payable in advance after receipt of invoice.
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.
Testimonials
