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5 Tips to Avoid FDA Data Integrity Violations


To keep pace with life sciences and manufacturing developments in the last few years, and following an uptick in data integrity violations, the U.S. Food and Drug Administration (FDA) continues to stress its data integrity guidance as part of Current Good Manufacturing Practices (CGMP). Referencing its previous standards, the FDA has strengthened its position regarding the following of those guidelines from a “good-to-have” to insisting organizations have a quality management system (QMS) in place, with all that entails, to ultimately remain compliant with CGMP. Companies and organizations can no longer rely on simply self-policing and preparing for sporadic audits. They must be prepared to submit documentation to the FDA on a regular cadence and have their systems scrutinized.

Examples of Data Integrity Violations

The problem of data integrity violations isn't going away. Whether due to user error, lack of knowledge, or system failure, even the most on-top-of-it company can be caught off-guard, leading to slowdowns in production, noncompliance, and reputational and financial damage. Below are some common violations to watch out for.

  • No standard procedures governing the audit trail.
  • Missing or deleted raw data files.
  • No plan for evaluating data integrity practices and procedures.
  • Passwords and usernames shared between employees.
  • Lack of data integrity risk assessment.

Read on for tips on how you can combat violations and strengthen your adherence to CGMP by focusing on data integrity.

FDA Data Integrity Expectations

Before we can discuss how to remain in sync with FDA data integrity guidance, here's a refresher on what the FDA means when they say, “data integrity.” According to FDA guidance “'data integrity' refers to the completeness, consistency, and accuracy of data.”1 To achieve said integrity, data should adhere to certain stipulations.

Luckily the FDA came up with a handy acronym to help us along in understanding these stipulations: ALCOA. Below is a brief reminder of what each letter stands for.

A - Attributable
L - Legible
C - Contemporaneous
0 - Original
A - Accurate

Now that we've gotten that out of the way, below are five tips to staying in step with FDA data integrity expectations for CGMP.

5 Tips to Achieving FDA-Compliant Data Integrity

This is by no means a complete list. However, it's a good place to start that can lead you toward compliance and away from data integrity violations.

1. Look for ways to improve data collection

Implement a reliable data collection process that ensures data will remain accurate, complete, and consistent. It is better to start with a robust collection system than to correct records in retrospect. Purpose-built data integrity software can help you achieve a streamlined data collection system so you can avoid lost data and version confusion. Research options to find the system that best meets your needs.

2. Review your checking process

Adopt a rigorous checking system by asking colleagues to always ensure that human error is not responsible for data integrity nonconformance.

3. Keep an eye on company culture

Instill a culture of data integrity through training, education, and awareness of threats, and the need to protect data accuracy, completeness, and quality. When everyone is on the same page you can avoid violation scenarios like the sharing of system passwords. Everyone should share the responsibility of maintaining data integrity.

4. Leave an audit trail

Creating an audit trail minimizes data integrity risk by showing where data has originated and how it has been used, transferred, and transformed through its life cycle. This can show the FDA you have a thorough plan for assessing risks and increases your ability to act proactively.

5. Invest in purpose-built automated tools

Implement error-detection software that automatically identifies anomalies and helps prevent future errors. Again, do your research to determine what solutions will best help you achieve strong data integrity and CGMP compliance.

These are only a few ways you can strengthen your data integrity and ultimately ensure compliance to FDA CGMP. To learn more about how you can eliminate errors with the right data integrity software and read further on how digitizing can keep you compliant, now and in the future, visit MasterControl's Quality Excellence page


Johanna Blair is a marketing content writer at MasterControl, contributing her distinctive voice to varied content including white papers, industry briefs, blog posts, and social media. She has a background in health care and medical education administration, where she witnessed the profound impact life science innovation has on the lives of patients and trainees, daily. She holds a Bachelor of Fine Arts with an emphasis in theatre performance from the University of Utah.

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