Computer Software Assurance

Consistent application of the risk-based approach

Even today, systems are still only subjected to an inadequate risk assessment and all functions are tested and documented without taking the risk into account. In some companies, this has led to a hesitant introduction of new systems, as the validation effort is considered too high and the value of validation too low. The digitalization of the life science sector has therefore progressed more slowly than in other industries. The responsible authority in the USA (FDA) then developed the Computer Software Assurance approach with industry experts in order to reduce these hurdles without compromising on quality assurance. GAMP 5 and ICH guidelines have also long called for a risk-based approach that allows validation efforts to be scaled and focused on higher risk areas.

Computer Software Assurance (CSA) is a modern approach to software quality assurance that focuses on critical thinking processes and the management of risk to ensure the reliability and safety of computer software in regulated environments, such as the pharmaceutical and medical device industries. Unlike traditional methods that rely heavily on extensive documentation and formal validation processes, CSA promotes more efficient testing and evaluation of software by prioritizing risk assessment and management. This approach allows organizations to focus on the aspects that are most important to product quality, patient safety and data security, while reducing compliance costs and accelerating innovation.


  • Risk assessment and management based on intended use/ intended purpose
  • Development of risk-based test strategies
  • Risk-based reduction of documentation efforts
  • Introduction of agile methods in line with CSA approaches
  • Optimization of software development and maintenance processes
  • Customized training and workshops on CSA principles and risk management
  • Adaptation of validation processes with regard to the CSA approach

Computer Software Assurance for high-performance software

The most important steps of Computer Software Assurance are defined:

  • Intended use: Clear outline of the intended purpose and initial risk assessment
  • Consistent application of the risk-based approach for sub-areas and functions of the software
  • Determining the appropriate test approach based on the identified risk
  • Selection of a suitable documentation approach that also saves time and resources

It should be emphasized that CSA does not replace the known validation approaches described in GAMP5®, PICs or EU-GMP Annex 11, but complements them. The CSA approach is primarily aimed at testing the software within the computerized system and therefore does not cover all aspects of the computerized system. This differentiation is not insignificant: a computerized system always includes the business processes, the user, the documentation and the operating environment of the system. A computer system, and the associated testing, is therefore only one component of the broader concept of a computerized system in the holistic validation approach, as described in GAMP 5.

The CSA process, on the other hand, is primarily aimed at the group of software developers and software quality assurance (SQA) specialists. Although Computer Software Assurance is a consistent application of the established GAMP® principles, it primarily looks at isolated software. The embedding of the software in the hardware environment or surrounding processes are not the direct focus of CSA, but depending on the individual system and scenarios, CSA approaches can also be applied in these areas.

QFINITY: Der Spezialist für Computer Software Assurance und vieles mehr

In the computer software assurance approach, the consideration of the respective individual risks is focused on three areas:

These and other relevant risk criteria are just some of the many reasons why only specialists should be trusted with the validation of relevant software areas. With its methodological competence and holistic approach, QFINITY has developed outstanding expertise in the past, including in the area of agile software development for innovative applications and cloud-based solutions. QFINITY’s innovative services link complex technologies with a consistent and efficient validation framework within the existing quality management system with processes, structures and specialist areas so that these can be mastered independently by the customer in the long term and permanently meet regulatory requirements.

As a highly specialized management consultancy for risk-based quality management, quality assurance, GxP compliance and continuous improvement of processes and computerized systems, QFINITY is also the first point of contact for all aspects of computer software assurance. The compliance consultancy for companies in the pharmaceutical and medical device industry and in the healthcare sector ensures holistic quality management and efficient production cycles for a steadily growing number of satisfied customers – over 140 from start-ups to SMEs and global corporations.

QFINITY is happy to support you in the development and introduction of risk-based quality management, quality assurance of processes, data and systems. We offer you competent consulting services for the successful company of tomorrow – just get in touch with us!


Computer Software Assurance is an approach developed based on the traditional validation approach to achieve an efficient balance between testing activities and documentation requirements in the context of the development and validation of software for or in the pharmaceutical, medical device and healthcare industries.

Computer Software Assurance from QFINITY, like all of the specialist’s services, is characterized by expertise, tailor-made solutions and innovative industry know-how, based on a customer base of more than 140 customers from the regulated environment.

Computer Software Assurance ensures the smooth functionality of all relevant processes relating to the use and validation of complex software applications through extended risk-based testing activities while reducing the amount of documentation required.