Data integrity: Practical guide to compliance

Maintaining data integrity in the Life Sciences sector is essential to ensuring the reliability, accuracy and traceability of the information used in the research, manufacture and distribution of medicines.

Complying with regulatory standards is not only a legal requirement, but a guarantee to ensure the safety and efficacy of pharmaceutical products. However, evaluating compliance with required standards can be a challenge.  

In this guide, we will show you how to effectively evaluate data integrity compliance in your organization. We will explore the best practices and key steps you must follow to ensure that your data is protected and remains intact.

Start evaluating Data Integrity compliance today!

What is data integrity? 

Before diving into how to evaluate Data Integrity compliance, it is important to understand what this concept entails. Data integrity refers to the accuracy, consistency, and reliability of relevant GxP data throughout its life cycle.

The data life cycle has the following stages:

ISPE® GAMP®: Records and Data Integrity Guide, 2018 

In the pharmaceutical context, evaluating data integrity means ensuring that all information generated and used in regulatory processes, clinical trials, and production complies with ALCOA++ principles.  

This process is crucial to guarantee confidence in the information used for decision-making in the organization. It is also essential for complying with regulations and standards that may apply to your company.  

Why comply with data integrity?

Data integrity is vital for any organization. If data is not intact, the information provided cannot be trusted. This can lead to erroneous decisions that directly affect product quality and, consequently, patient health.

Focusing on the pharmaceutical sector, the regulatory framework provides various regulations and guidelines that establish the criteria to comply with data integrity in the pharmaceutical industry.

Evaluating data integrity compliance means moving towards the quality and safety of relevant GxP data and, therefore, guaranteeing the quality of the manufactured product.

Common challenges in Data Integrity compliance

Although data integrity compliance is essential, there are common challenges that organizations face when trying to achieve it. These challenges include:

• Complexity of systems and processes: In many organizations, data is collected and stored across a variety of different systems and databases. This can make tracking and verifying data integrity difficult across all storage and processing points.
• Unauthorized access to data: Data security is a key factor in maintaining data integrity. Unauthorized access can compromise data integrity and put information confidentiality and accuracy at risk.
• Lack of awareness and training: Employees are often not fully aware of the importance of data integrity and the measures needed to maintain it. A lack of training on this topic can lead to careless practices that compromise data integrity.
• Lack of resources and budget: Implementing effective measures to maintain data integrity may require significant investments in terms of resources and equipment. Organizations may face limitations in these aspects, making it difficult to implement best practices and appropriate technologies.
• Errors in data entry: Defining technical controls on systems, or communication interfaces between systems, to minimize human errors in entering critical data.

Facing these challenges and overcoming them is fundamental to guaranteeing Data Integrity compliance in your organization. Below, we detail the key steps you can follow to evaluate and improve your compliance.

Steps to evaluate data integrity compliance

Evaluar el cumplimiento de la integridad de los datos requiere una metodología estructurada y un enfoque sistemático. A continuación, presentamos los pasos clave que puedes seguir para llevar a cabo una evaluación efectiva:

1) Perform a data integrity audit

The first step to evaluate data integrity compliance is to perform an exhaustive audit of the systems and processes used to collect, store, and process data in your organization. This audit must include a detailed review of existing policies and procedures, as well as an evaluation of implemented security measures.

To do this, an initial compliance analysis (DIRA) is performed, where any weak point or vulnerability in systems and processes that could compromise data integrity is identified. This may include issues such as lack of appropriate access controls, system configuration errors, lack of data traceability during its life cycle, or the absence of periodic data backups.

2) Identify key components of data integrity compliance

Once you have performed the audit, it is important to identify the key components of data integrity compliance that apply to your organization. These components may vary depending on the industry and the specific regulations you must comply with.

Some key components may include:

• Policies and procedures: Establish clear policies and procedures to guarantee data integrity in all aspects of the organization. Principles allowing proper data governance, computerized system validation that incorporates technological controls, etc., must be defined.
• Access security: Implement appropriate access controls to guarantee that only authorized personnel have access to data.
• Traceability: It is essential to maintain data traceability throughout its entire life cycle, from creation to archiving. Therefore, computerized systems used to create, process, and maintain data must have audit trail records logging data history.
• System controls: Define controls within systems generating relevant data to ensure compliance with ALCOA++ information principles. For example, the system must log who and when creates or modifies a data point.
• Define action sequence: Avoiding user error is fundamental; therefore, a key point is defining controls and sequences within the computer systems used. These controls and sequences should help the user avoid making errors in the process sequence or data entry, for example.
• Data backups: Perform regular data backups to ensure data is not lost in case of an incident or system failure. Also have an approved and tested Disaster Recovery Plan.

3) Adopt best practices to maintain data integrity compliance 

In addition to performing necessary evaluations, it is important to adopt best practices to maintain data integrity compliance over the long term.

Some of these practices include:

• Build awareness and train personnel: Ensure all employees are aware of the importance of Data Integrity and train them on best practices, establishing regular training programs. It is useful to provide examples and case studies showing the impacts of lack of data integrity and how they can be avoided.
• Establish proper access controls: Implement solid access controls to guarantee that only authorized personnel have access to data.
• Validation of computerized systems: Include all controls a system must have within the computerized system validation policy to guarantee data integrity compliance. In this way, controls will be included in the validation process, ensuring their evaluation and testing prior to use in the company's production environment.
• Perform regular audits: Perform regular audits to continuously evaluate data integrity compliance and detect any weak points.
• Interfaces between systems: To avoid errors in entering critical data, it is highly recommended to define and validate communication interfaces between computerized systems. Thus, we reduce the focus of errors caused by manual data entry.
• Establish data retention policies: Establish clear data retention policies to ensure data is kept for as long as necessary and securely destroyed when no longer needed.

Guarantee the reliability and accuracy of your data!

Evaluating data integrity compliance is fundamental to guarantee the reliability and accuracy of information used in regulatory-relevant processes (GxP). By following the steps and best practices mentioned in this guide, you will be able to evaluate and improve Data Integrity compliance in your company.

Remember that data integrity compliance is not a single objective, but a continuous process. It is important to perform regular evaluations, stay updated with the latest technologies and regulations, and continuously train employees to maintain a high level of data integrity.

Do not allow data integrity to become a weak point for your company. Take action today to evaluate and improve data integrity compliance and guarantee the reliability and accuracy of your information.

If you would like to receive consulting on your company's data integrity or train your team on Data Integrity, contact our expert team.

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At Ambit Iberia, we offer consultancy, audit, and specialized training services to help you excel in the regulated sector. Click here to get in touch with us.

At Ambit Iberia we have been experts for over 20 years in developing IT strategies and solutions. We help the pharmaceutical, medical device, and IVD (in vitro diagnostic) medical device sectors comply with regulations throughout the entire product life cycle. We design and implement innovative infrastructures thanks to a global service offering as an enabling lever for digital transformation.