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+41 (0)61 712 33 33

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CSV
CSV

CSV

A MEANINGFUL VALIDATION OF COMPUTER SYSTEMS
WITH DIQUALIS

A risk-based validation of your computer systems gives you the certainty that your systems meet regulatory requirements while providing the best possible support for your processes. Such a validation is more than meeting regulatory requirements. It ensures a high-performance IT infrastructure that truly drives business processes. We support you in finding and carrying out the right scope and efficient procedure.
Communication is the first step to success. Contact us.

YOUR CHALLENGE
– OUR SOLUTIONS

An increasingly complex IT landscape offers more and more possibilities and challenges validation processes that have been in place for many years. Computer systems as stand-alone solutions with limited functionality and tasks have become IT landscapes: Within them, systems of different types and architectures, including applications in the cloud, are interconnected and diverse processes are mapped in the data exchange. This situation requires adapted validation strategies that meet the risks and opportunities of complex IT landscapes, including cloud solutions, and fulfill regulatory requirements. As external consultants, we work with you to develop validation strategies that are adapted to your specific situation and actively support you in implementing these strategies.

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.

VALIDATION SPECIALIST

As validation specialists, we support you in the validation of computer systems and thus reduce the workload of your internal experts.

QA MANAGER

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

PROJECT MANAGER

As external project managers, we take care of the implementation of computer systems including the validation of these 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

We have many years of experience in several validation projects in companies of different sizes and cultures. Therefore, we can not only provide advice regarding validation processes, but also support you in performing the actual validation of your computer systems.
Beratung

VALIDATION IMPLEMENTATION

Are you about to implement a new computer system and lack internal resources to perform a proper validation? You want to assess the risks of implementing a new computer system or changing an existing one in order to perform a risk-based validation?
Then you have come to the right place – we support you in specific validation projects from different points of view.

VALIDATION CONSULTING

Do you want to put your established validation processes to the test in terms of efficiency and compliance? Do you want to standardize your different validation processes or pay more attention to the risk of data and processes in the validation process?
Then you have come to the right place – based on our many years of experience, we can provide you with competent advice on all aspects of the validation of computer systems.
Datenstruktur
Datenstruktur

Validierungs­beratung

Sie wollen Ihre etablierten Validierungsprozesse hinsichtlich Effizienz und Compliance auf den Prüfstand stellen? Sie wollen Ihre unterschiedlichen Validierungsprozesse vereinheitlichen oder das Risiko von Daten und Prozessen im Validierungsprozess stärker berücksichtigen?
Bei uns sind Sie richtig – wir beraten Sie aufgrund unserer langjährigen Erfahrung kompetent in allen Aspekten der Validierung von Computersystemen.

OUR SERVICES

OPTIMIZATION OF EXISTING VALIDATION PROCESSES
Efficient validation implementations can be hindered by outdated validation processes that may even still be paper based. We support you in implementing modern, risk-oriented processes that are efficient and still meet the regulatory requirements.
COMPLIANCE ASSESSMENT OF IT PROCESSES
Computer systems must be maintained in a validated state. IT processes such as change and problem management play an important role in this aspect. We understand the challenges of IT processes in regulated environments and can provide advice on issues regarding the compliance of IT processes.
GAP ANALYSIS OF THE VALIDATION STATUS OF COMPUTER SYSTEMS
Especially the validation status of computer systems that have been in use for many years requires a critical review on a regular basis. In this context, the timeliness of the validation documentation is checked and updated, if necessary. At the same time, the scope of testing is evaluated and, if necessary, additional testing is performed.
TEST MANAGEMENT
The description of tests that are as simple as possible to perform, including the definition of the associated test data, is an essential part of test management. This also includes the guidance of the testers to ensure a careful execution and documentation of the tests.
ORGANIZATION AND IMPLEMENTATION OF THE SYSTEM SELECTION
Product characteristics and the manufacturer’s suitability must be considered in the system selection. In the regulated sector, the manufacturer's quality management requirements are also taken into account. We know the market and can assist in the system selection.
COMPILATION OF USER REQUIREMENTS
Many user requirements are industry- and process-specific standard. Therefore, they do not need to be worked out from scratch in every project. We know these requirements. The focus can then be more on defining specific requirements that are essential for the success of the project.

YOUR ADVANTAGES WITH DIQUALIS

With DiQualis, you use the advantages of the risk-based approach to computer validation. Your added value:

RECOGNIZING POTENTIAL FROM A NEUTRAL EXTERNAL PERSPECTIVE
PRAGMATIC DOCUMENTATION
TURN A COST FACTOR INTO A SUCCESS FACTOR
CONTINUOUS COMPLIANCE FOR COMPUTER SYSTEMS
EFFICIENT VALIDATION OF COMPUTER SYSTEMS
COMPUTER SYSTEMS THAT MEET THE REQUIREMENTS

Validation is more than just meeting compliance requirements. A validation that reviews the functions and data flows of computer systems on a risk basis with regard to their suitability for the company’s own processes supports the processes within the company by providing computer systems that meet the requirements. This validation process is accompanied by efficient documentation that precisely describes the risks, the resulting procedure and the results of the validation in order to make the validation process comprehensible. Efficient documentation simplifies the implementation of changes to the computer system and the resolution of problems, including the associated update of the documentation. This ensures continued compliance throughout the lifecycle of the computer system.