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DI Compliance

DI Compliance

MANAGE DATA INTEGRITY EFFICIENTLY WITH DIQUALIS

Data integrity is an integral part of the existing regulations and maintaining compliance is essential for companies concerned. Through risk-based and practical solutions, we ensure your data integrity compliance from development to market production. We support you conceptually, during project implementation and in your day-to-day business.

YOUR CHALLENGE
– OUR SOLUTIONS

Data we use to make everyday decisions must be reliable and trustworthy. This is especially important in a regulated environment, where decisions always have to be made faster and could ultimately affect patients. We support you in intrinsically ensuring the required regulatory data integrity within your organization. Our risk-based approach hones in on the critical aspects, eliminates them and, with reliable data, provides the necessary time frame for your important decisions.

DIQUALIS SUPPORTS YOU
IN VARIOUS FUNCTIONS/ROLES:

CONSULTANT

We are able to act as a consultant on all issues related to data integrity and ensuring compliance.

 

 

 

 

 

 

 

 

 

 

Projektmanager

We act as a project manager to design your data integrity projects and internal processes in a target-oriented manner and lay the foundation for long-term success.

 

 

 

 

 

 

 

 

QS employee

To ensure the long-term success of your internal measures, we train your employees on an individual and company-specific basis.

OUR EXPERTISE

Unstable foundation, unstable house. That is why DiQualis focuses on three fundamental aspects which play an essential role in ensuring DI compliance.
Datenstruktur

Processes and data flows

Do you need a clear overview of your processes, data processing systems and data flows? Would you like to know all the stages of the data lifecycle? Are you concerned that data integrity risks have not yet been identified? Are you looking for appropriate measures to mitigate these risks?
Then you can trust us – your partner for DI compliance issues and solutions.

System and data classification

Would you like to capture and clearly classify all relevant systems? Do you need support in classifying your data and identifying required data retention periods? Are you unsure about the efficiency of your audit trail control strategy?
Then you can trust us – your partner for system and data classification concepts.
GxP
GxP

System- und Datenklassifi­zierung

Würden Sie gerne alle relevanten Systeme lückenlos erfassen und eindeutig klassifizieren? Vermissen Sie Unterstützung bei der Klassifizierung Ihrer Daten und der Zuordnung der geforderten Aufbewahrungsfristen? Zweifeln Sie an der Effizienz ihrer Audit-Trail-Kontrollstrategie?
Dann wenden Sie sich vertrauensvoll an uns – Ihr Partner für System- und Daten-Klassifizierungskonzepte.
Dokumentablage

Data migration and archiving

Do you need support in planning and carrying out DI-compliant data migrations? Are you looking for a competent partner to help create archiving concepts and implement them?
Then you can trust us – your partner for DI-compliant data migration and archiving concepts.

OUR SERVICES

DI training for your employees
Data integrity is directly linked to employee behavior and mindset. To ensure and promote the necessary awareness of data integrity and related controls, we train your employees in areas relevant to your organization. In doing so, the content is tailored to your needs and practical in nature. A simple and effective performance review is included.
Creation & implementation of migration and archiving concepts
The retention and archiving of relevant data, including their readability over defined periods of time, is required by law. On the business side, the reproducibility of data is often required as well. Solutions range from migration concepts to the virtualization of entire systems. We create and implement customized compliant migration and archiving concepts for your data.
Implementation of process analyses
We create and analyze your processes and your data flows to identify data integrity risks. Following this, we create a plan of action for you to ensure your company’s data integrity in the long term. Any potential synergies are identified and implemented as agreed.
Project management
At your request, we can take charge of project management in various areas of data governance and data integrity. As a result, you conserve internal resources, and you also benefit from effective implementation by our experienced project managers.
Data Governance and Data Integrity Consulting
All of our consultants have many years of practical industry experience in a regulated environment and are therefore able to understand your situation. Regular training keeps their knowledge up to speed and allows them to implement the current regulatory requirements in a practical manner. Thanks to their experience in industry, our consultants see the bigger picture and identify potential synergies for your business process.

YOUR ADVANTAGES WITH DIQUALIS

With DiQualis, you can achieve sustainable DI compliance:

Practically oriented solutions, future-oriented and sustainable
Recognize synergies from a neutral, external perspective
Save internal resources and expenses
Become inspection-ready with proven data integrity
Effective and secure handling of relevant data
Recognize synergies from a neutral, external perspective

We will take charge of creating your data integrity strategy, including the implementation of practical solutions which are compliant with regulations. This includes the analysis of your processes and data flows, accompanied by system and data classifications as well as adapted migration and archiving concepts.

From our neutral, external perspective, we see the bigger picture and can identify both gaps and potential. We see identified risks as opportunities for future-oriented and sustainable solutions. You will benefit from our consultants’ practical industrial experience, and they will always be able to understand your situation.