What is the difference between computer system validation (CSV) and computer software assurance (CSA)?

Computer System Validation (CSV) has been around since the introduction of FDA 21 CFR Part 11, 1997, the General Principles of Software Validation. Intended to ensure proper functioning of systems, CSV had the goal to ensure that auditors can get a detailed look at every aspect of an application used in production. Today, it has mutated into a burdensome exercise for audit proofing, resulting in enormous paper-based documentation packs with large volumes of screenshot or printout attachments.

CSA versus CSV

CSV has become a major point in audit preparation, creating unnecessary activities and bureaucracy. In the worst case, it can even hinder progress, by making updates or new software solutions incredibly difficult to implement due to extensive documentation requirements. It also locks up resources in documentation tasks, while neglecting testing and the original intention of ensuring that systems are fit for use and their functioning validated.

So, what is the difference between CSV and CSA? Computer system validation or CSV methodology has validation teams spending 80% of their time documenting and only 20% of their time testing systems. The US Food & Drug Administration (FDA) has recognized that the ‘test everything’ approach is becoming outdated as it leaves GMP manufacturing facilities spending more time on documentation than on actual testing. The goal is to turn this around: focus on testing and document where necessary. The FDA has therefore started to promote what it calls Computer Software Assurance or CSA. With CSA 80% of the time should be spent on critical thinking and applying the right level of testing to higher-risk activities, while only 20% of time is spent on documentation. In this process, critical thinking should be focused on three questions:

  • Does this software impact patient safety (Pharma) or consumer safety (Food)?
  • Does this software impact product quality?
  • Does this software impact system integrity?

Using a risk-based approach is something the FDA already applies in their audits. It is important to notice that the upcoming CSA guidance document brings no change to the current governing regulations or to the Good Automation Manufacturing Practice guide release 5 (GAMP 5); the requirements remain the same. However, following the CSA approach means that validation activities are designed around testing the critical aspects in an efficient and focused way. The goal is to avoid unnecessary activities and bureaucracy. Instead, critical thinking and a risk-based approach are used to ensure that testing focuses on the features and/or actions that pose a medium to high risk to patient and/or consumer safety, product quality and/or data integrity. Less focus is spent on the lower risk features of the system. Executing an appropriate Quality Risk Assessment prior to start other validation activities becomes essential.

Where does CSA apply?

The current indication is that the shift towards CSA should be considered for the validation of the following systems (non-limitative list):

  • Enterprise Resource Planning (ERP) systems 
  • Electronic Quality Management Systems (eQMS) with functionalities like   
    • Document Management  
    • Learning Management 
    • Event Management 
  • Laboratory Information Management Systems (LIMS) 
  • Serialization systems

A good CSA program can be easily implemented and will benefit from a strong Quality Management System. With a CSA approach, these systems can be implemented in a much more agile way than applying the classical CSV approach. Applying CSA is then no longer a burden but becomes a distinguisher for success while CSV is considered more the qualifier.

Our Q7 recommendations when applying CSA:

  • A thorough supplier audit may provide justification to leverage supplier testing. This means that you do not need to repeat testing already performed by your vendor. If the vendor has a strong quality management system or QMS in place and has already validated the offered system, then there may be no requirement for the user to re-validate the out-of-the-box features.
  • Use a risk-based approach to define what functions, features or aspects of the computerized system are high-risk to patient/consumer safety, product quality and/or data integrity. These high-risk areas require intensive testing if not already been tested by the qualified vendor. Medium or low risk functions, features or aspects may require less or even only informal testing.
  • Clearly define the scope of validation. In case an existing system is changed, focus the testing mainly on the changed functionality. Follow an agile approach for development and consider unscripted testing as part of the validation approach for low-risk testing.
  • Have a clear and simple policy in place that says how testing is conducted (for example, collection of documented evidence and validation non-conformance management), how training is done and how validation is summarized. This will ease execution and make the approach transparent and understandable for all involved in testing.
  • Where possible, use testing tools for automated assurance activities instead of manual testing. Automated tools provide the advantage of reduced errors in testing, maximizing the use of resources and can reduce risk. Finally, ensure you know the intended use of the system. Keep that in mind when defining what is required.

To conclude, with the introduction of CSA, there is no change to the current governing regulations or to GAMP 5. Important is to make the shift to the right mindset : focus on critical thinking and defining the high-risk areas. Testing is focused on these areas accordingly.

Use CSA is a distinguisher for success and stay away from the burdensome exercises of CSV. If your company is ready to make the change but needs support on the implementation, Q7 Consulting will be happy to help you. We have the experienced resources to support you in the transition to an efficient validation approach and have more than two decades of successful track record in implementing CSV and CSA .

Change Management Interview: Anna Khodosevich

At Q7 Consulting, we are aware that Change happens faster and more frequently than ever. As a result, Change Management and Leadership within organizations are essential pillars for success.

The people we interview are from all around the world, have outstanding professional trajectories and attained success within their roles. They have essential leadership traits, are influential within their organizations and have experience implementing and managing Change.

In this tenth episode of our new series, we interview Anna Khodosevich, a Senior Scientific Consultant and Strategic Research Support Coordinator at Drug Design and Pharmacology sector.

Please find below the main questions addressed in our interview with Anna Khodosevich and her answers to the same.

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Change Management Interview: Judy Ang

At Q7 Consulting, we are aware that Change happens faster and more frequently than ever. As a result, Change Management and Leadership within organizations are essential pillars for success.

The people we interview are from all around the world, have outstanding professional trajectories and attained success within their roles. They have essential leadership traits, are influential within their organizations and have experience implementing and managing Change.

In this ninth episode of our new series, we interview Judy Ang, independent Accounting and Finance Consultant with great experience leading teams in Singapore, applying her knowledge in accounting and finance to effectively execute Change in organizations.

Please find below the main questions addressed in our interview with Judy Ang and her answers to the same.

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Virtual Office: Microsoft Teams

In the article Virtual Office: Which platform is for you? we identified three main digital collaboration platforms: Google Workspace, Workplace by facebook and Microsoft Teams. In this article we will talk about Microsoft Teams, its main features and how Q7 Consulting can help you implement a set of guidelines to collaborate successfully.

Many people and organizations use Microsoft Teams strictly for videoconferencing and chat, two very important features that amount to about 25% of what Microsoft’s platform can do for you.

Q7 Consulting can help you unleash your organization’s potential to plan, manage & execute projects, communicate & collaborate seamlessly, organize cloud storage and much more by using one platform: Microsoft Teams. But first, let’s look at a preview of some of the platform’s main features.

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Change Management Interview: Carlos Alberto Arnaud Gil

At Q7 Consulting, we are aware that we live in uncertain times, and that Change management and leadership are now more than ever essential to the success of organizations.

The people we interview are from around the world and have exemplary career paths. All of them have achieved success within their roles, have essential leadership traits, are influential within their organizations, and have experience implementing and managing Change.

In this eighth episode of our new series, we interview Carlos Alberto Arnaud Gil, Psychiatrist, Professor, Lecturer and Coordinator of the Mexican Psychiatric Association in Nuevo León. He will give us a different perspective on Change management and leadership, which is not much talked about but is extremely important: mental health.

Below are the questions addressed in our interview with Carlos Alberto Arnaud Gil.

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Virtual Office: Which platform is for you?

Digital Transformation implies Change. This Change is necessary when organizations seek to be competitive in their industries and markets but also to overcome day-to-day obstacles. The COVID-19 pandemic has forced Change on organizations and pushed some to the brink of survival, scrambling to find new ways to create value.

In many countries, government measures and consequently company initiatives prevented people from attending physical offices or restricted face-to-face collaboration to a certain degree. These circumstances enabled many solutions, services and products to arise and tackle newfound challenges. One of these challenges is team collaboration in a seamless and efficient manner.

In this article we tackle the platforms existing today enabling teams to collaborate remotely. Do they boost your productivity and fit your organizational culture? Which one to choose?

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Change Management Interview: M. Kumaresan

At Q7 Consulting, we are aware that we live in times of uncertainty and now more than ever Change Management and Leadership within organizations are essential concepts for success.

The people we interview are from all around the world, have outstanding professional trajectories and attained success within their roles. They have essential leadership traits, are influential within their organizations and have experience implementing and managing Change.

In this seventh episode of our new series, we interview M. Kumaresan, Head of Information Technology at Unichem Laboratories Limited who provides deep insight on planning and executing Change.

Please find below the main questions addressed in our interview with M. Kumaresan with some examples embedded in the answers.

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Change Management Interview: Paul Maya

At Q7 Consulting, we are aware that we live in times of uncertainty, and now more than ever Change Management and Leadership within organizations are essential concepts for success.

The people we interview are from all over the world, have outstanding career paths, have achieved success within their roles, have essential leadership traits, are influential within their organizations and have experience in implementing and managing Change.

In this sixth episode of our new series, we interviewed Paul Maya, CEO of Atos Mexico – North America who has more than 30 years of experience in the areas of Strategic Planning, Startups, Business Development, Operations and Information Technologies, with various roles and projects including business software design and development for manufacturing, transportation and retail industries. Paul has carried out the planning and startup of several large-scale Technology Centers in Mexico and South America, including all areas of technology for mission-critical infrastructure support and software development. He has also been responsible for the implementation of ISO certifications and compliance programs for different industries.

Please find below the questions and answers addressed in our interview with Paul Maya.

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Change Management Interview: Robert Brasser

At Q7 Consulting, we are aware that we live in times of uncertainty, and now more than ever Change Management and Leadership within organizations are essential concepts for success.

The people we interview are from all around the world, have outstanding professional trajectories, have attained success within their roles, have essential leadership traits, are influential within their organizations and have experience implementing and managing Change.

In this fifth episode of our new series, we interview Robert Brasser, a Vice President of IT and Digital who has 30 years profound knowledge and experience in structuring, executing and enforcing Change in different corporate settings, cultures and countries around the world. Robert Brasser provides his insight and personal experience throughout the interview with examples from his professional life, giving us clear ideas on how to Manage and Lead Change in different situations.

Please find below the main questions addressed in our interview with Robert Brasser with some examples embedded in the answers.

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Change Management Interview: Geraldine Maouchi

At Q7 Consulting we are aware that we live in times of uncertainty and organizations need to be flexible and must have strong cultures of Change Management and Leadership in order to succeed. The current pandemic has brought on many challenges but also many opportunities for organizations. One of the opportunities is to ride the increased wave of Digital Transformation and as with any transformation, Change Management and Leadership are essential.

Continuing our new series: interviews we have personally done to industry leaders, business managers, chief officers and entrepreneurs from all kinds of professional backgrounds and industries, getting their perspectives on how they managed and implemented Change in their organizations and throughout their professional careers; in this fourth episode we interview Geraldine Maouchi, leading expert in Transformation across several industries and organizations with the profile of a Chief Digital Officer (“CDO”), sharing her knowledge through academia and providing enriching content through several articles.

In this interview we tackle another main topic in addition to Change Management and Change Leadership: Digital Transformation. As the implementation of Digital technologies were reaching their limits in several ways such as scalability, ROI, talents management… it became obvious that implementing Digital in a traditional organization requires a full transformation of the organization.

Please find below the main questions addressed in our interview with Geraldine Maouchi with to the point answers for easy reading.

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