Your company cannot operate without a level of reliance on computer systems. New technology and the industry hot topic “data integrity” (“information availability, authenticity, correctness and traceability”) are driving greater adoption of computerised information systems.

In response, regulators like the TGA, FDA and Medsafe are increasingly scrutinising the validation of computer systems. As such, you must apply an appropriate level of risk-focused validation effort for your computer systems and organisation to be compliant.

The Computer Software Assurance (CSA) approach is being widely discussed for its use of critical thinking and risk assessment.

This course will provide you with an overview of what matters in validation of computerised systems (including CSA) to help your company meet regulatory requirements and mitigate risks to product quality and patient safety.

Content

Through this course you will develop an understanding of:

• Common terms and definitions of Computer Systems Validation
• Types of, and elements of System Development Life Cycles (SDLC)
• Good Automated Manufacturing Practices (GAMP)
• What is critical for data integrity in the eyes of GxP regulators
• How computer systems are regulated in PIC/S (e.g. TGA and Medsafe) and FDA environments
• How to implement a CSA approach through worked examples
• How to recognise the compliance, risk and regulatory consequences of using computer systems

Participants

You will benefit from this course if you are a key Quality, IT or Operational Subject Matter Expert (SME) or Manager likely to be involved in using, validating, approving or purchasing computer systems.

Format and Course Length

The course is entirely online and on-demand built with a number of modules (i.e. topics) containing various content sections. Training content is a mix of video (with audio where the trainer speaks to a PowerPoint presentation), documents, images, weblinks and quizzes.

Available 24/7, you can undertake the training at any time and over multiple sessions as you need; the Matrix Learning Management System (LMS) will save your progress so you can continue in the next session from wherever you're up to. The training is self-paced, so you can progress as quickly or slowly as you need. The course includes ~3.5 hours of videos (as microlearnings) as well as reference documents, in-learning quizzes and a final assessment. Your licence grants you access to the course for 30 days.

What Do I Need?

Participant needs are very basic. You will need a computer or suitable device with a good internet connection. A headset may be useful if you undertake this course in a shared environment due to the audio.

Workshops

This CSV on-demand course is a pre-curser to optional live instructor-led workshops that you may also be interested in participating in and you can register via the links here:

1. CSV Workshop (#1) Regulations (~ 1 hour)
   • We’ll discuss the FDA Environment, 21 CFR Part 11 and PIC/S Annex 11 and use this to explore areas of control within your company. We will then discuss specific Annex 11 clauses relevant to your requirements.
2. CSV Workshop (#2) CSVMP and Infrastructure Qualification (~1 hour)
   
   • We’ll walk through both a Computer System Validation Master Plan and an Infrastructure Qualification Plan to highlight the importance of the overarching validation framework.
3. CSV Workshop (#3) Risk Assessment and Practical Validation (~2 hours)
   • We'll work through a macro risk assessment, then use that risk assessment to discuss a CSA validation approach. We will then work through a full project validation example focussing on the validation plan, requirements, design and testing. This will highlight how knowledge gained at the system testing can flow back into the end-user testing.

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