An Introduction to Computer Systems Validation

Computer Systems Validation, or Electronics Systems Validation (CSV for short) is a unique beast.
Done well, it doesn’t have to turn into a Nightmare on Elm Street!

This series of posts will go beyond the guidelines, using real-life experiences from the industry to highlight the pitfalls and challenges that can be routinely faced, provide some suggestions on how to avoid these, and ultimately achieve the CSV goals and add value using practical solutions which meet regulatory expectations.

Similar enough in concept to other forms of validation – for example, equipment, process, methods etc – but different enough to guarantee that even the Subject Matter Experts in those other areas can often find themselves struggling.

That is not to suggest that CSV is in any way an impossible intellectual challenge, just that it retains an unerring sense of mystery to many; a Dark Art if you will.

In my experience, many companies will have exactly ONE PERSON who is an expert in Computer Systems Validation, with everyone else in those organisations more than happy to let that single individual simply get on with it quietly and not bother them too much as a result.

A regulatory box is ticked; everyone is happy.

What is often the case however is that some companies will only have that one person, but they are not an expert per se. They may know a bit about CSV, and are happy to “give it a go”, but as Alexander Pope stated in 1711, “A little learning is a dang’rous thing”…

Regulations…

The regulatory requirements must be met of course, and I will start and end with these regulations – which can be paraphrased into three words, namely, “you must validate”. I will also reference the industry guidelines such as the Eudralex Volume 4 -Annexes 11 and 15, GAMP 5 and PIC/s publications, and some ISO standards where appropriate.

However, this narrow-concept of “you must validate” consequently means that CSV is seen by many as nothing more than a necessary evil, and very much restricted in scope to the domain of GMP-impacted systems.

Not only is this view short-sighted – as CSV should be performed for all regulated systems (and not just those designated as GxP) – but it has been shown demonstrably that there are tangible benefits for following CSV concepts for the implementation, update and maintenance of all electronic systems in an organisation, regulated or otherwise.

What practitioners will already know is that the Regulations state what has to be done, and the Guidelines describe the best methods and processes used to realise the Regulations.

But together they still fall a little short of the reality of putting it all into practice.

A Practical Pathway…

Experience suggests that taking a practical pathway through CSV, based on the principles of quality risk management, can not only make the process more streamlined but will also ensure a greater buy-in from the wider stakeholders. This is through delivering a correctly working system on time and within budget (and by extension minimising the bottom-line costs for the business managers), while all the while ensuring that all-important regulatory compliance.

It is important that business decision-makers understand the roles and responsibilities of who needs to be involved with regulated electronic system implementations and ensure that the right individuals are included in decisions at the start of the process.

Too often there is a “Oh we probably should get Quality and that CSV person involved” type of discussion near the end of the implementation process. By this time of course it is probably too late and will almost certainly result in project delays, additional resource requirements, and budget-overspends; all of which the Quality and CSV functions then get the blame for…

Even worse is when the Quality department finds out about it all as the system is about to go live, and is forced to make an urgent intervention.

How these discussions can be managed effectively, and who ultimately is responsible will be discussed in a later post.

Problem Subjects…

There are certain problem subjects I will return to on a regular basis – in particular vendors, management and education as these are challenges that will crop up over and over again.

I will dedicate some significant page space to vendors. They can be the CSV practitioner’s best friend, but also their biggest headache and source of frustration.

In this series of posts, I will try to follow a typical CSV process through the various stages in a logical progressive order, offering practical and pragmatic real-life advice on how to succeed at CSV. This will include simple solutions that all stakeholders can understand and buy-in to.

Areas I intend to cover in this series will include:

  • Why Validate?

  • Roles and Responsibilities Involved

  • The User Requirements Specification

  • Risk Assessments

  • Vendors

  • System Development

  • The Validation Planning

  • Qualification Stages

  • Cloud Hosting / SaaS

  • Data Migration

  • Specific Regulatory Considerations

  • Audits and Auditors

  • Data Integrity

  • Legacy Systems and Gap Analyses

  • Control Systems

  • In-House Developed Applications (such as MS Excel and Access)

  • Artificial Intelligence (AI) Systems

I will also be sharing insights into two contrasting real-life case studies:

One of a system implementation that got there in the end, but took a very troubled route over a long and bumpy road, and…

One that went “very smoothly indeed”

There are learnings to be taken from both!

So, these series of blogs are aimed at:

Those single individuals in each organisation who are responsible for CSV

Those individuals who are happy to stick their heads above the parapet and ‘give it a go’

The equipment, process and method validation experts who have CSV handed to them as an extra

The Quality Managers and QPs / RPs who require an overview and top-level understanding of the subject matter

The Auditors who need to better understand where to start and what questions to ask

Anyone with a general interest who wants to understand the subject in more depth, and what it can mean for their organisation

Note: The terms “Validation” and “Qualification” often get used interchangeably as a general word for “verifying a system is fit for purpose”, and no confusion should be taken if they are mixed up. Even after many years in the industry performing CSV it is still very easy to do, and I make no apologies if I do so accidentally!

In the upcoming series of posts, I will discuss why we validate, what the regulations actually say (and don’t say), the tangible benefits of validation, and who needs to be involved from Day One (and why).

To find out how we can help your organisation with your Computer Systems Validation and Data Integrity needs please get in touch at consultancy@jensongroup.com or to read more about our CSV services, please click here.

Read all posts in this series:

Neil Rudd
2024-01-22T09:34:01+00:00October 31st, 2023|
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