The Importance of Gap Assessment on Data Integrity Before an FDA Inspection

From 2015 to the end of 2019, conducting a Data Integrity (DI) Gap Assessment at a pharmaceutical company of any size was a widespread tool, and the results of such activity provided a mapping of the gaps of every computerized system and allowed for defining a roadmap to remedy and release the involved Computerized Systems.  During 2020, in the midst of the pandemic, the entire pharmaceutical world had to adapt to the pandemic situation, and the approach to many of the assessments were changed, becoming primarily remote using technical support equipment (e.g., Google Glass or similar), but losing much of their effectiveness by not being able to work directly on the system/machine to be evaluated.  In recent times, the world has effectively emerged from the pandemic period, so in 2024, the onsite DI Gap Assessment tool is returning to be central in helping pharmaceutical companies define remedial activities on their own Computerized Systems. 

Why Should a Company Perform a DI Gap Assessment?

Here are some valid reasons why a company should conduct an assessment on its Computerized Systems:

1. Identification of Improvement Areas 

A detailed Gap Assessment allows for the identification of areas where data management processes and systems may not comply with FDA requirements. This enables the company to take corrective measures before the inspection, reducing the risk of non-compliance that could lead to penalties, product withdrawals, or reputational damage. 

2. Improvement of Data Quality

 Data integrity is crucial for product quality and patient safety. Identifying and correcting gaps in data management processes helps improve the quality of the data itself, ensuring that it is complete, accurate, protected, and accessible only to authorized personnel. 

3. Preparation for FDA Inspection

 An FDA inspection can be a stressful and challenging event for any pharmaceutical company. Being prepared means having confidence in your own data management processes and systems. A properly conducted Gap Assessment helps the company face the inspection with greater serenity, knowing that the main issues have already been identified and resolved. 

4. Adaptation to New Regulations 

FDA regulations on Data Integrity are continuously evolving. Regular Gap Assessment allows the company to stay updated on the latest regulatory developments and adjust its processes timely, ensuring ongoing and proactive compliance. 

How to Conduct an Effective Gap Assessment? 

Here are the main points where a DI Gap Assessment will be organized to be effective and produce consistent results: 

1. Planning

The first step is to plan the assessment, defining clear objectives, scope, and necessary resources. It is important to involve all stakeholders, including Quality, IT, and Production departments. 

2. Data Collection 

Detailed information on current data management processes, including data collection, storage, access, and protection methods, should be collected. This may include interviews with staff, review of documents, and analysis of computer systems.

3. Analysis 

Be sure to analyze the collected data to identify discrepancies relative to FDA regulatory requirements. This may include verifying the completeness of data, accuracy, traceability, and security. 

4. Report and Corrective Actions 

A detailed report highlighting identified gaps and recommending specific corrective actions should be prepared. It is essential to establish an action plan with clear timelines and defined responsibilities. 

5. Monitoring

 A continuous monitoring system should be implemented to ensure that corrective actions are effective and that data management processes remain compliant over time.

Conclusion 

The Gap Assessment on Data Integrity is a crucial element for pharmaceutical companies wishing to ensure compliance with FDA regulations, and will assist the companies in adequatelypreparing for inspections. It not only helps to identify and correct gaps in data management processes, but also contributes to improving the overall quality of products and protecting the company's reputation. Investing in an accurate and regular Gap Assessment is, therefore, a winning strategy for any company engaged in the pharmaceutical sector.