Ensuring data integrity in the long term - iTernity (original) (raw)

Definition and protective measures

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Companies make important business decisions based on data. However, if this data contains errors or is even lost, this can have fatal economic and legal consequences. That's why it's crucial to safeguard the integrity of electronic data during its lifetime or retention period.

What is data integrity?

What is data integrity?

Data security and data integrity

Data security is an important component of data integrity. It ensures the protection of company data against misuse, and describes measures and techniques to shield data from unauthorized access.

Data integrity describes certain requirements for the protection and quality of digital data. To maintain data integrity, the consistency, completeness, accuracy, and validity of data must be ensured throughout the entire retention period. All data changes must be documented in a traceable manner so that data cannot be changed or manipulated unnoticed or without authorization. Data integrity thus has the overriding goal of protecting data from internal and external breaches.

The cornerstones of data integrity are data protection regulations, such as the GDPR and data security principles.

Loss of data integrity can lead to compromised data and have far-reaching consequences for companies. Serious data breaches and business decisions based on incorrect data can - in the worst case - threaten the very existence of companies.

Standard and definitions

Is there a standard for data integrity?

Despite the importance of the topic, there is no general consensus on the definition of data integrity. Nevertheless, it is crucial for companies to ensure the integrity of electronic data during its lifetime or retention period. In industries such as pharmaceuticals and healthcare, strict data integrity rules apply. Here, maintaining data integrity is an essential aspect of compliance requirements.

Thus, it becomes apparent that data integrity is dependent on legal requirements and industry-specific regulations, and its definition is tied to the context in which data is stored.

Definition from the GDPR:

The General Data Protection Regulation (article 5/1f) in relation to the storage of personal data: "Personal data must be processed in a manner which ensures appropriate security of personal data, including protection against unauthorized or unlawful processing and against accidental loss, destruction, or damage by appropriate technical and organizational measures ("integrity and confidentiality")."

Part of the German Fiscal Code, the GoBD are "Principles for the proper management and storage of books, records and documents in electronic form and for data access".

Definition from the GoBD:

Definition of the GoBD1 (margin note 103) on the storage of tax-relevant data: "The taxpayer must secure its DP system against loss (e.g. untraceability, destruction, decay, and theft) and protect it against unauthorized entries and changes (e.g. through access controls)."

Industry-specific definitions of data integrity

Data integrity in pharma & life sciences:

US FDA definition (21 CFR Part 11, Electronic Records): "Data integrity refers to the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be assignable, legible, original or copy recorded simultaneously, and accurate."

The FDA (Food and Drug Administration) uses the ALCOA principle to define a standard for data integrity. ALCOA Plus (ALCOA+) extends these conditions to include Complete, Consistent, Enduring, and Available.

As regulators become more stringent in their inspections, it is critical to be able to demonstrate compliance. The parameters of the ALCOA principle create a benchmark for holistic documentation here, which other industries also follow.

Data integrity in healthcare:

U.S. Department of Health and Human Services (HIPAA) definition: "Data integrity means that data or information is not altered or destroyed in an unauthorized manner."

Data integrity in the financial sector:

Payment Card Industry Data Security Standard (PCI DSS) definition: "Changes which disrupt data integrity are unauthorized, including alterations, additions, and deletions."

The PCI Security Standards Council uses the term "file integrity" instead of data integrity. The definition of file integrity can be found in the definition of "file integrity monitoring". It states that file integrity is a technique or technology under which specific files or logs are monitored to determine if they are modified. Further, PCI specifies that changes, additions, and deletions are classified as unauthorized changes which may interfere with file integrity.

Data integrity threats

Data integrity threats

The integrity of data can be impacted by a variety of threats. These include:

Measures to ensure data integrity

Measures to ensure data integrity in the long term

So how can data integrity be protected? With the following points, you have the four most important measures at hand to maintain data integrity and minimize risks in your company:

An audit trail should have the following characteristics:

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  1. Your Challenges
  2. Archiving
  3. Ensuring data integrity in the long term