Software Validation

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Our fully interactive Software Validation training course provides attendees with the knowledge and skills they need to comply with European, US and Worldwide software validation requirements. The course is fully tutor-led and focuses on the practica... Read More

Our fully interactive Software Validation training course provides attendees with the knowledge and skills they need to comply with European, US and Worldwide software validation requirements. The course is fully tutor-led and focuses on the practical implementation of software validation requirements. The course provides attendees with a well-thought-out approach and real-world implementation methodologies, to help achieve compliance and assure consistency of performance of computerised systems. The course addresses the use of software and computerised systems in QMS, production, testing and distribution. Risk Management of software and computerised systems, and scaling of validation effort in proportion to risk are covered in detail. The course also covers the latest FDA Requirements and Guidance on Electronic Records and Signatures (21 CFR Part 11) and Data Integrity. The course involves practical group exercises which take the learner through the entire validation cycle with comprehensive feedback from the course tutor throughout.

For abbreviations used in this document, see end of document.


What's covered?

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  • The Need for Software Validation
  • European and FDA Regulations and Guidance on Software Validation
  • Software Validation Regulations interactive quiz New
  • The latest FDA Guidance on Software Validation New
  • Group Discussion the latest FDA Guidance on software validation New
  • The GAMP Approach to Software Validation
  • GAMP Categorization case study New
  • The V Model Approach
  • V Model Approach interactive exercise
  • Software Validation Planning - designing master validation plans
  • Writing Software Validation Rationales New
  • Case Study - determining what needs to be included in the MVP for a specific manufacturing process New Content

DAY 2 

  • Requirements Specifications - Case Study writing a URS
  • Application of Risk Analysis to Software Updated Content
  • Software Design Qualification
  • Requirements Tracing – using the RTM to plan qualification testing
  • Case Study - writing an equipment IQ Protocol
  • Software Testing and Software Test Environments
  • Software Testing Interactive Exercise
  • Case Study - writing an equipment OQ Protocol
  • Application of Statistics to Software Validation New Content
  • Statistical Rationale for Samples Sizes Updated Content

DAY 3 

  • Electronic Records and Electronic Signatures
  • 21 CFR Part 11 Interactive Exercise
  • Application of the FDA Guidance on Part 11
  • Data Integrity and Software Validation New
  • Software Performance Qualification
  • Case Study - writing a Software PQ Protocol Updated Content
  • Leveraging Supplier documentation for off-the-shelf systems Updated Content
  • Validation Reporting - How to Report on Software Validation testing New
  • Maintaining the Validated State Updated Content
  • End of Course Assessment. New

Who should participate?

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Personnel in the Pharmaceutical/Medical Device/Healthcare sectors who need to gain a solid practical foundation in how to perform Computer Systems and Software Validation in a regulated environment.

What will I learn?

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Upon completion of this course, participants will be able to;

  • Identify the regulatory requirements for software validation,
  • State the benefits of conducting software validation,
  • Categorise software in accordance with GAMP guidelines,
  • Apply the V Model to software validation,
  • Appreciate European and FDA Guidance publications on software validation,
  • Design a software validation master plan,
  • Write user requirements for software and computerised systems,
  • Assess software and computerised systems risks,
  • Identify the main requirements for Electronic Records and Electronic Signatures,
  • Apply the FDA guidance on 21 CFR Part 11 to software systems,
  • State the main Data Integrity requirements,
  • Complete a software DQ,
  • Write IQ test cases for computerised systems,
  • Identify challenge tests for software systems,
  • Write Software OQ test cases,
  • Write Software PQ test cases,
  • Report on Software testing results,
  • Leverage vendor documentation to minimise validation effort,
  • Assist in ensuring that the validated state is maintained.


Abbreviations used in this document:

CPD: Continuous Professional Development
DQ: Design Qualification
GAMP: Good Automated Manufacturing Practice
IQ: Installation Qualification
MVP: Master Validation Plan
OQ: Operational Qualification
Part 11: 21 CFR Part 11 Electronic Records and Electronic Signatures
PQ: Performance Qualification
RTM: Requirements Traceability Matrix
URS: User Requirements Specification

Who are the tutors?

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How do we train and support you?

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In-House Courses
Course tutor will contact your organisation in advance to discuss the programme in detail.
In-house courses can be customised to meet your organisation’s specific requirements.

Course Manual
Delegates will receive a hardcopy course manual with relevant course materials.

Share this Programme


Course Code
3 training days
Public Price
Virtual Training: €995

(includes course documentation).

Delivery Mode
This programme is delivered by Classroom, Virtual Training, or In-Company training
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What Our Learner's SayWhat Our Learner's Say

The course content and delivery was excellent. John is very experienced on the subject matter & delivered the content very clearly and kept our attention and focus. I would highly recommend this course to my collogues.
Dave L April 25, 2024
I found this course very helpful. Coming from virtually no background in software validation, the 3 days covered a huge amount of valuable knowledge which I will use in my current role. John was extremely knowledgeable. The course material was excellent and the right amount of interaction was involved
Jennifer P April 25, 2024
Very good training. I learned a lot about CSV. The trainer was very knowledgeable and likeable.
Juenevive F December 7, 2023
great course.
Manish M December 7, 2023

News & UpdatesNews & Updates

Understanding the Software Validation Requirements of ISO 13485:2016

With the transition of many medical device companies to ISO 13485:2016 “Medical Devices – Quality Management Systems – Requirements for regulatory purpose...

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Software Validation

Duration: 3 days **
  • 24 - 26 Sep 2024
    Location: Virtual Book Date
  • 03 - 05 Dec 2024
    Location: Virtual Book Date

Software Validation

Duration: 3 days
Virtual Training: €995
  • 24 - 26 Sep 2024
    Delivery: Virtual Training
    Location: Virtual
    Book Date
  • 03 - 05 Dec 2024
    Delivery: Virtual Training
    Location: Virtual
    Book Date