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Data Integrity (DI)

Data Integrity


By ensuring data integrity, you as a pharmaceutical or chemical company make sure your data is correct and consistent. Reviewing the current data integrity status and implementing compliance solutions are part of our core competencies. We help you establish risk-based processes in your daily work routine in order to achieve complete data integrity in accordance with applicable regulations. To ensure that long-term DI compliance in particular is successful, we also offer company-specific DI checks and DI training.


Data is a valuable resource for companies and the basis for important decisions, not only in medical, pharmaceutical and chemical companies. Data security is not the only omnipresent issue due to the sensitive nature of the data. Inconsistent or inaccurate data, whether stored electronically, e.g. in databases, or paper-based, pose a great risk to the trust in your company and ultimately to your company’s success. By taking appropriate measures regarding the data integrity, you minimize the risks of a lack of reliability and meaningfulness of your data and can ultimately trust the information included in that data. We provide you with advice on the applicable regulations for data integrity to give you a better overview of legal regulations on data security and integrity. We are also happy to act as project managers to help you define DI compliance measures and establish them in your company.

A number of measures are necessary to ensure data integrity, since data integrity encompasses the entire data lifecycle: from entering and processing data to securing it and finally to the planned destruction after a defined period of time. The requirements for data within the data life cycle can be described using the ALCOA+ principles:

  • Attributable
  • Legible
  • Contemporaneus
  • Original
  • Accurate
  • + complete, consistant, enduring, available

Processes should be created to make data entry and processing traceable and transparent, ensure the legibility, guarantee the correctness of the information and secure the data. When the importance of the principles is fully recognized and established, the current and future data integrity is ensured.

To achieve this, it is important to create risk-based and practical processes that should include the following points, among others:

  • Ensuring correct data entry
  • Validation of data transfer interfaces
  • Qualification of data backup solutions
  • Clear definition of roles and the associated rights
  • Ensuring and maintaining data legibility
  • Options of filtering data that is to be deleted (if applicable)
  • Data migration concepts (if necessary)

Control mechanisms should already be in place when data is entered, such as the four-eyes principle for manual entry or entry via barcode. Especially if a large number of users have access to the application and enter data, it is important to standardize and validate the process to minimize errors. When data is exchanged between multiple systems, validation is required for the interfaces to ensure consistency and correctness and to maintain data integrity. When implementing new software versions of existing applications or new application software that replaces existing software, data legibility must always be ensured, if necessary through data migration.

RIn the process of data integrity measures, redundant data should be avoided, tracked down regularly and removed in a controlled manner, based on risk. This applies in particular to the data transfer to consolidated databases. For data that is supposed to be deleted at a specific time, the option to filter is important. Automated solutions make it much easier for you to keep your data management consistent and to ensure regular backups to prevent data loss. Whether your data is stored on your company’s servers or in the cloud, the ALCOA+ principles for maintaining data integrity are always valid and applicable.

Ultimately, you benefit from a high data quality and reliability, information quality and effective knowledge management for your company and your customers.

Every day, data records are collected, entered and edited, and new data is entered into the system or database. Without defining specific control strategies, data integrity cannot be implemented in the long term. We support you in creating control processes that are actively used in the company. To achieve this, we develop practical solutions that suit your workflow. After all, data integrity should not be achieved at the expense of efficiency. At the same time, we place great importance on a risk-based approach in order to identify and eliminate critical aspects and to help you ensure the reliability of your data, which ultimately also determines the information quality of your databases. We provide you with advice to help you keep track of all legal and regulatory requirements and be prepared for future changes. As an external auditor, we also perform various system and data audits to verify the data integrity from the data entry to the final report. As members of your team, we implement the resulting measures and optimization potential securely.