Data Integrity: The Next Step in Computer System Validation

In our Computer System Validation course, offered May 20-21 in London, our instructors will discuss key concepts in computer system validation including FDA regulations, non-compliance issues that can result in warning letters, and implementing a practical-but- defensible computer validation system for your development programs. While these foundational topics are excellent for those who are new to data validation and equipment regulations, it’s important in this industry to stay abreast of new technological developments that can ensure the success of your drug development projects.

With this in mind, those working in computer validation system need to ensure they’re not only aware of possible software failure, but are also taking into account any data integrity breaches that can jeopardize the success of your projects.

Data validation ensures that data is secure and accurate over its entire lifecycle. Considering data is the lifeblood of any drug or medical device development project, data integrity is central to the storage and retrieval of the associated data.

Currently, the FDA monitors data integrity, and any breaches or security issues are subject to regulatory action including warning letters. The FDA is also investing in training for its auditors so that they can recognize potential data integrity issues during systems inspections.

Now that smartphones have become an integral part of our workplace, and the line between personal and office equipment has blurred in response, data integrity becomes even more important. Using smartphones in the calibration process, for example, can be a possible source of a data breach.

The FDA stipulates that data security includes protection against loss, tampering or alteration and accidental deletion. It should be noted that whether the loss of data is accidental or occurs on purpose, the results for your project will be the same. When the drug discovery market is projected to be $71 billion USD by 2025, protecting compounds in development by protecting the associated data gains material importance. Computer system validation, including software testing and hardware validation, is only one piece of the puzzle to ensure your data is secure.

If you would like to learn more about data integrity, our knowledgeable instructors are prepared to take questions about this crucial area during the course. You can also contact us to learn more about protecting your data, or to request the addition of a data integrity course to our programming.
 

Source:

http://www.pharmatimes.com/web_exclusives/exploring_validation_and_data_integrity_in_pharma_1246876