Back in 1997, the increased use of computerized systems in the pharmaceutical industry forced the United States Food and Drug Administration (FDA) to launch the 21CFR Part 11, which regulated the GxP electronic data management. This regulation was focused in ensuring that the same degree of confidence was achieved in electronic data and in paper records.

The interpretation of this regulation was provided by a series of guides which resulted in the Scope and Application Guidance, which stands as the standard interpretation since 2003.

As seen in the previous posts, GMP have undergone a paradigm change at all levels, evolving with globalization and technological advances. The change in the rules of the game has caused a response from both health authorities and the industry itself, creating solid cyclical quality systems based on a risk analysis approach and comprehensive design phase. These systems are greatly dependent on data, so the lack of proper data management jeopardizes the entire Quality System.

This rate of findings related to improper data management during inspections has surged since 2014, when lack of understanding or improper implementation of data management processes was detected (mainly in, but not restricted to, electronic data). This forced the agency to increase the inspection pressure and focus on the availability of the necessary controls for ensuring the integrity of GxP-relevant data.

Finally, the FDA formalized these expected controls as a Guideline on Data Integrity and Compliance with cGMP. Simultaneously, the European Health Authorities, who were also facing the same kind of problems, issued their own guides on this topic. Most of this can be found in this post from our GMP Series. The most advanced guidance to day is the one issued by the USFDA in December 2018.

All these new guidelines on Data Integrity have updated the expectations of Health Authorities in data management topics, thus complementing the existing regulations on Electronic Data management (21CFR Part 11 / EUGMP Annex 11) as well as paper data management processes This, in turn, has forced the pharmaceutical companies to upgrade their internal processes accordingly.



As we have seen, the paradigm change in GMP is a reality today, based on an evolution that has occurred in recent years. Nowadays, Quality Systems rely on data both as records of activities and as foundation for decisions, thus being necessary to ensure that data is reliable. This Data Integrity should be achieved through the design of the appropriate controls.

However, it is important to know that even though Data Integrity constitutes a key element of the pharmaceutical Quality System, GxP regulations and expectations go far beyond that. In conclusion, ensuring Data Integrity alone may not be sufficient to ensure compliance.

Be sure to join us in the upcoming posts, where we will show real examples found in inspections, we will break down the critical areas in data management and offer practical solutions to achieve a state of compliance with current regulations.