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IT-Compliance

IT-Compliance

RELIABLY MEET IT GUIDELINES AND STANDARDS WITH DIQUALIS

There are certain guidelines and standards that corporate IT has to adhere to. This is stated in the IT compliance. The compliance with all regulatory requirements is especially important for pharmaceutical, healthcare and chemical companies. DiQualis supports you in the validation of computer systems (CSV) and the implementation of innovations, such as the Computer System Assurance (CSA). In order to establish efficient procedures regarding CSV and CSA, we are happy to train your employees in on-the-job trainings.
CSV

CSV

CSA

CSA

Schulung

SUCCESSFULLY IMPLEMENT IT COMPLIANCE

The lack of IT compliance can cost your company a lot of money. To ensure that regulatory requirements are met on a sustained basis, we offer you customized solutions, for example regarding the computer system validation or the computer system assurance. In close collaboration with you, we implement legal, corporate and contractual requirements concerning the IT compliance. Through on-the-job training, we also ensure that your teams are well prepared for IT compliance tasks and that there is an overall standard for the validation of computer systems.

Especially for companies in the pharmaceutical industry, meeting all regulations related to the IT compliance is essential. The goal is to implement applications that are fit for purpose. This includes regulatory requirements as well as functional user requirements.

How you benefit from IT compliance:

  • Compliance with all regulatory requirements
  • Fulfillment of user requirements
  • Data traceability
  • Fit-for-purpose applications
  • Data integrity

With our trained eye, we analyze the entire IT structure and provide you with advice on the implementation of suitable IT systems. This ensures that the data stream from research to production remains available, traceable and safe from manipulation. In the role of the project manager, we control the restructuring process in order to establish IT compliance in the long term.

An advantage and at the same time a challenge of IT compliance is its validity for all levels of the organization. By establishing a legally compliant and efficient IT compliance management, all employees benefit from the access to the information and the data traceability. Thanks to our individual, industry-specific solutions, the secure handling of data and information can be conveniently included in the daily workflow. The focus is always on your specific user requirements. Depending on the current state of your IT structure, however, this may require extensive changes that also affect the handling of the IT systems. In order to establish the perfect IT management, we not only provide advice but also actively support you in implementing the new processes and measures. This ensures that functional and regulatory compliance requirements are met for all processes, from research to production.

Nowadays, intelligent IT solutions are essential for production and laboratories. Modern solutions, such as cloud-based applications, help facilitate everyday work and turn computer systems into entire IT landscapes. However, this also increases compliance requirements concerning the validation, data availability and security. The more complex the IT infrastructure and the more sensitive the data, the more important comprehensive IT compliance becomes. We share our know-how in the areas of CSV and CSA with you. Using field-tested validation strategies and a risk-based approach, we ensure that your computer systems comply with current standards and are prepared for risks.