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CSA
CSA

CSA

IMPLEMENTING NEW
COMPUTER SYSTEM ASSURANCE WITH DIQUALIS

Computer System Assurance (CSA) is a new development in the validation of computer systems. Heralded as a paradigm shift, CSA presents itself as a logical continuation of the risk-based approach to computer system validation. We support you in recognizing and utilizing the opportunities and risks of CSA.
Communication is the first step to success. Contact us.

YOUR CHALLENGE
– OUR SOLUTIONS

Critical thinking instead of creating documentation as an end in itself: this is part of the quintessence of CSA. In many validation projects, extensive documentation is created without questioning whether this amount of documentation is necessary and adds value to the quality of a computer system. Critical thinking is based on the risk-based approach of validation and asks for critical functionality, appropriate test methods and the appropriate documentation. As external consultants, we help you apply these principles to your validation strategy.

DIQUALIS SUPPORTS YOU
IN VARIOUS FUNCTIONS/ROLES:

CONSULTANT

As your consultant, we look at your validation processes and work with you to develop more efficient alternatives.

VALIDATION MANAGEMENT

As validation managers, we independently carry out the validation of computer systems in collaboration with the responsible specialists in your company.

Validierungsspezialist

Als Validierungsspezialist unterstützen wir Sie bei der Qualitätssicherung von Computersystemen gemäss CSA und reduzieren so die Arbeitslast Ihrer internen Fachleute.

QA MANAGER

As QA managers, we evaluate your validation processes and accompany you as external quality assurance regarding the validation of computer systems.

Trainer

To ensure the long-term success of your validation strategies, we train your employees individually and company-specifically in validation-related topics.

OUR EXPERTISE

A risk-based validation as the basis of CSA principles is not new to us. In several validation projects, we have chosen this approach to ensure the quality of computer systems with a reasonable effort. We see CSA as a consistent continuation of the risk-based approach.
Beratung

CONSULTATION

You want to know what possibilities CSA offers? You want to understand the paradigm shift from documentation to critical thinking as a consistent application of previous validation principles? You want to know what this means for your validation processes in specific terms?
Then you have come to the right place – based on our many years of experience with the risk-based validation approach, we can provide competent advice on all aspects of CSA.

APPLICATION

Do you want to improve the quality of your computer systems without increasing the validation effort even more? Do you want to apply new test concepts and documentation strategies when implementing a computer system?
Then you have come to the right place – we support you in implementing CSA in specific projects.
Datenintegrität
Datenintegrität

Anwendung

Sie möchten die Qualität Ihrer Computersysteme verbessern, ohne den Validierungsaufwand noch weiter zu erhöhen? Sie möchten neue Testkonzepte und Dokumentationsstrategien bei der Implementierung eines Computersystems anwenden?
Bei uns sind Sie richtig – wir unterstützen Sie bei der Umsetzung von CSA in konkreten Projekten.

OUR SERVICES

REVISION OF VALIDATION AND DOCUMENTATION PROCESSES
CSA does not mean no documentation at all, but rather reducing unnecessary documentation and focusing on the essential documentation. This makes validation processes, including the risk assessment, comprehensible. We support you in evaluating documentation and work with you to develop CSA-compliant documentation concepts.
DEFINING A TEST CONCEPT
Depending on the risk assessment, CSA allows testing by experienced users without a detailed test script. This waiver of documentation can mean a quality gain if the testers' experience can be incorporated into the test process. We support you in defining a test strategy that takes into account the entire range of testing possibilities.
RISK ASSESSMENT
Critical thinking includes the recognition and assessment of the risks of computer systems, their functions, and associated data and processes. This assessment is the basis for test strategies and the documentation scope. Together, we identify and assess risks.

YOUR ADVANTAGES WITH DIQUALIS

With DiQualis, you use the advantages of Computer System Assurance – both short-term and long-term. Your added value:

INCREASED RISK AWARENESS
EFFICIENT VERIFICATION OF COMPUTER SYSTEMS
IMPROVED QUALITY OF COMPUTER SYSTEMS

CSA is not a reduced validation; it is the continuation of the risk-based approach. This increases awareness of the risks of computer systems and their associated data and processes – when the risk identification and assessment are performed with the necessary accuracy. Focusing on the critical data and functions leads to more efficient testing of a computer system for its usability for the intended functions. This means an improvement in the quality of computer systems.