4 Data Integrity Issues Your Compliance Systems Should Address

Data integrity is the continued accuracy and consistency of data. Data integrity is essential in the pharmaceutical, biotechnology, medical devices, and skincare and cosmetics industries. 

Your organization must show how you are maintaining quality standards and control of your research, data, and the products you produce.

As technology continues to evolve, data integrity in pharma has never been more important. And, as expected, FDA regulations continue to evolve.

1. Inadequate Investigations

There has been a spike in FDA letters over the last few years that cite inadequate data quality at drug manufacturing plants. You may think that these letters would create a domino effect of extensive investigations, but that has not been the case.

The investigations have not been extensive enough, and they are not getting to the root of the problem in the industry. These inadequacies will likely lead to increased scrutiny, and further investigations as the FDA works to streamline the investigation process.

2. Inaccurate Reporting

The FDA stated in 2017 that there were “significant issues” when it came to inaccurate reporting of microbial, sterility, and endotoxin data results. In a field where the collection and accuracy information is vital, one inaccurate report can lead to a chain reaction of inaccuracies.

The reliability of the information that is being reported is used to ensure the quality of the drugs. Inaccurate reporting can severely jeopardize the health and safety of the manufacturing process, which can lead to dangerous side effects for patients.

3. Loss of Data

During system changes, there has known to be some major losses of data. This has caused some setbacks in the industry and has become a notable issue.

With new technologies and software always in development, the need for safe and secure data storage is more important than ever.

Your organization's ability to maintain data integrity relies on your ability to source a viable solution for storing your sensitive information.

4. Manipulation of Electronic Records

The digitization of data has caused some major issues in the pharmaceutical industry. Almost all of our data is stored online. This increased risk can lead to data manipulation, deletion, and modification that may violate FDA regulations.

Ensure that your organization is compliant by following current regulations surrounding data integrity.

Are Your Data Integrity Practices FDA-Compliant?

The Center for Professional Innovation and Education (CfPIE)  is an industry leader in providing professional training and development for companies working in the pharma, biotech, medical device industries. 

Our Computer System Validation helps your employees learn more about developing and implementing regulated computer systems with an appropriate level of documented evidence to satisfy FDA expectations.

Are you interested in improving your FDA compliance? Contact CfPIE today to learn more.