Data Integrity with 21 CFR

Meaning of Data Integrity Data Integrity with 21 CFR, Data integrity, as defined in 21 Code of Federal Regulations (CFR), particularly in the context of pharmaceutical and related industries, refers to the completeness, consistency, and accuracy of data throughout its life cycle. Ensuring data integrity is critical to maintaining the quality, safety, and efficacy of […]

Meaning of Data Integrity

Data Integrity with 21 CFR, Data integrity, as defined in 21 Code of Federal Regulations (CFR), particularly in the context of pharmaceutical and related industries, refers to the completeness, consistency, and accuracy of data throughout its life cycle. Ensuring data integrity is critical to maintaining the quality, safety, and efficacy of medicines.

The U.S. Food and Drug Administration (FDA) emphasizes the importance of data integrity in a variety of regulations, including 21 CFR Part 11 (electronic records, electronic signatures) and 21 CFR Part 211 (Current Good Manufacturing Practices for Drug Products). These regulations establish requirements for the creation, modification, maintenance, retrieval and storage of documents and electronic signatures, as well as documentation practices for production processes.

The key principles related to data integrity according to 21 CFR are:

  • Attributable
  • Legible
  • Contemporaneous
  • Original
  • Accurate
  • Complete
  • Enduring

Data must belong to the person who performed the action or recorded the information, ensuring accountability and traceability of the data.

To maintain accountability and traceability throughout the process, it is important to assign data to those responsible for creating or recording it. By linking data to specific individuals, organizations can establish a clear chain of accountability, increase transparency, and promote effective decision-making. This approach not only promotes integrity, but also helps identify errors, resolve discrepancies, and comply with legal requirements.

Let’s consider a real medical scenario. When a nurse administers medication to a patient, this action should be attributed to the nurse who performed it. Healthcare facilities ensure accountability by recording the names of healthcare workers along with records of medication administration. If a problem such as an adverse reaction or medication error occurs, the nurse in charge can be immediately identified and corrective action can be taken quickly. Additionally, during regulatory audits or inspections, clear data attribution can help demonstrate that a facility complies with established protocols and standards.

Additionally, in industries such as finance or manufacturing, connecting data with the people involved in key transactions or processes is equally important. For example, a financial institution must be able to track the specific employee who initiated or approved each financial transaction. This mapping not only helps detect fraudulent activity, but also allows companies to analyze performance, identify training needs and optimize processes.

Connecting data to people provides the foundation for accountability and traceability across domains. Whether in healthcare, finance, manufacturing, or other fields, this practice improves data integrity, promotes effective decision-making, and ensures regulatory compliance.


Data should be clear and easy to read. Permanent records must be made to prevent changes, and any changes must be documented with appropriate approval.

It is essential to ensure transparency and readability as well as integrity and security of data by permanently recording and properly documenting changes with approved approvals. This means that data must be presented in a way that is easy to understand and access, as well as stored securely to prevent unauthorized alteration.

Imagine a real-life scenario in a financial institution where customer transaction records are kept. Each transaction must be recorded clearly and accurately so that authorized personnel can understand all relevant details. For example, when a customer makes a deposit or withdrawal, the transaction details, including amount, date, and account information, must be clearly and accurately recorded.

Additionally, any changes or updates to the data must be carefully documented to maintain the integrity of these records. For example, if a customer objects to a transaction and requests a correction, the change in the transaction record must be clearly stated, the reason for the change, and whether or not a specific person, such as a manager or supervisor, has authorized it. This document not only ensures transparency but also serves as an audit trail for accountability.

By adhering to the principles of transparency, readability, integrity, and documentation, organizations can maintain the trustworthiness and trustworthiness of their data, ultimately increasing stakeholder trust and promoting informed decision-making.


Data should be recorded at the time of observation or action and not entered retroactively. This helps ensure accuracy and reliability.

To maintain accuracy and reliability, it is important to collect data concurrently with observations or actions rather than entering them after the facts have been confirmed. This approach ensures that data reflect the actual circumstances in which they occur and minimizes the risk of errors, omissions, or distortions that may arise due to memory errors or subjective interpretations.

For example, imagine a medical situation where a nurse is administering medication to a patient. Recording the dose, time of administration, and reactions observed immediately after the event ensures the accuracy of the medical record. Entering this information later increases the likelihood of errors due to the passage of time, the need for multitasking, and confusion with other patient information. This can have serious consequences, including incorrect treatment planning and reduced patient safety.

Even during the manufacturing process, real-time data recording during the production process allows deviations or errors to be quickly detected and corrected. Once information is collected, discrepancies may go unnoticed and lead to poor product quality, production delays, or safety hazards. Timely data collection serves as the basis for informed decision-making, process optimization and quality assurance in a variety of fields and prevents loss of subsequent data entry.


Data must be original or a faithful copy, and any copy made must preserve the content and meaning of the original data.
Data integrity requires that data remain reliable and unchanged throughout its lifecycle. This means that the data must be the original or master copy, and any duplicates must maintain the accuracy and validity of the original dataset.

For example, in the context of scientific research, maintaining data integrity is important to ensure the reliability of research results. Consider a scenario where a team of researchers is conducting an experiment to test the effectiveness of a new drug. Data collected during testing, including patient responses, doses, and observations, must be original and accurately recorded. If your research team needs to share this data with other scientists or regulatory agencies, you can make copies for distribution. However, such copies must reproduce the original dataset without modifications or omissions. Deviations from the original data can lead to misinformation or interpretation of test results, potentially affecting the validity of the study and influencing future treatment decisions.

Likewise, maintaining the integrity of financial information in a business environment is critical to decision-making and regulatory compliance. Let’s say a company prepares financial reports based on transactions recorded in its accounting system. These reports are used as a basis for evaluating company performance and making strategic decisions. Copies or extracts of this financial information, including reports or regulatory documents distributed to stakeholders, must accurately reflect the information contained in the original documents. Failure to maintain the integrity of financial information can result in reporting errors that can mislead investors, regulators and other stakeholders and result in loss of financial influence and trust.

Whether in scientific research, business operations, or other fields, maintaining the integrity of information by ensuring its originality or maintaining reliable copies is important to maintain its reliability, reliability, and usefulness.


Data must be accurate, consistent, and reliable. Any errors or discrepancies must be immediately identified, investigated and documented.
Ensuring data integrity is critical and requires accuracy, consistency, and reliability at all times. Imagine a situation where financial institutions rely on data to make important investment decisions. Correct information ensures the robustness and profitability of your investments. Data consistency ensures that trends and patterns can be reliably identified and managed, while reliability builds trust between stakeholders and investors. However, even in systems that are managed with the utmost care, errors and inconsistencies can occur. For example, inconsistencies in financial information can lead to poor investment decisions that can result in significant losses. Therefore, it is important to immediately detect, investigate, and document these errors or anomalies to quickly resolve them and prevent further negative impacts.

This rigorous approach not only protects data integrity, but also strengthens trust in the decision-making process and ultimately contributes to the success of the company.


Data must be complete and contain all relevant information necessary to understand its context and meaning.
It is important to ensure that the data is complete and includes all relevant information needed to understand its context and meaning. In practice, this means that each dataset should contain not only the underlying data, but also additional details that provide a broader understanding of the content.

Consider a sales report from a retail company. A comprehensive dataset not only lists total sales data, but also includes additional relevant information such as the time period, region, specific products sold, pricing details, customer demographics, marketing campaigns conducted during the time period, and external information. These are factors that affect sales, such as economic trends or seasonal fluctuations. By incorporating this additional data, stakeholders can understand the broader context surrounding sales statistics and support accurate analysis, decision-making, and strategic planning.

Moreover, integrity extends beyond purely quantitative aspects to qualitative aspects. For example, comprehensive data from a physician’s office includes not only numerical measurements but also qualitative descriptions such as patient demographics, medical history, lifestyle factors, and treatment protocols. This holistic approach allows researchers to thoroughly analyze data and make reliable decisions by considering all relevant factors that may affect results. Data integrity allows users to gain meaningful insights, make informed decisions, and take appropriate actions with a full understanding of the underlying information.


Data must be stored for as long as legally required and protected from loss, damage, or unauthorized access during storage and retrieval.
To maintain integrity and compliance within your organization, it is important to ensure that data retention complies with regulatory requirements and protects data from loss, corruption, or unauthorized access throughout its lifecycle. Compliance regulations, such as GDPR in Europe or HIPAA in the United States, require specific retention periods for different types of data, from financial records to personal health information. Compliance with these requirements not only reduces legal risks, but also strengthens trust between customers and stakeholders.

For example, consider a healthcare organization responsible for managing patient medical records. HIPAA regulations require that patient health information (PHI) be retained for at least six years from the date it was last created or used. Failure to comply may result in serious penalties, including fines and legal penalties. Therefore, healthcare providers must implement strict data retention policies and use secure storage solutions to ensure that protected health information remains accessible for as long as needed and is protected from breach or data loss.

Data Integrity and Why Is It So Important?

Data protection also goes beyond legal compliance and includes protecting confidential information that could harm individuals or jeopardize business operations. In the age of digital transformation, data breaches are becoming increasingly common and can have far-reaching consequences, including financial loss and reputational damage. Implementing encryption protocols, access control, and regular data backup are essential strategies for strengthening your data security system.

Organizations must take a proactive approach to data management, balancing regulatory obligations with data integrity and privacy needs. This not only helps mitigate legal risks, but also fosters a culture of trust and accountability among stakeholders, ultimately increasing competitive advantage in an increasingly data-driven environment.

Adhering to these principles ensures that data generated, recorded and managed in the pharmaceutical manufacturing process is reliable, verifiable and meets legal requirements. Failure to adhere to data integrity principles may result in regulatory action, including warning letters, fines, and product recalls. Therefore, pharmaceutical companies must establish robust data management systems and procedures to ensure data integrity throughout their operations. This is all about the Data Integrity with 21 CFR.

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