Currently, data integrity seems to be the topic everyone’s talking about. Irrespective of whether the records at hand are digital or paper, the question of the credibility of data has become more and more important in recent years. This is reflected by the increasing number of warning letters on this topic as well as the a priori assumption of non-compliance being made by the supervisory authorities.
One reason for these concerns is that a lack of data integrity in the pharmaceutical field can result in serious health consequences for patients. Data integrity in a GxP regulated environment, however, is nothing new.
Two points which are directly related to the term “data integrity” are the ALCOA/ALCOA+ principle and 21 CFR Part 11. The acronym ALCOA stands for ‘attributable’, ‘legible’, ‘contemporaneous’, ‘original’ and ‘accurate’; ALCOA+ additionally includes the criteria ‘complete’, ‘enduring’, ‘consistent’ and ‘available’. 21 CFR Part 11 deals with electronic records and electronic signatures.
This webinar will give you:
- A definition of the term “data integrity” as used by the FDA,
- A more detailed explanation of the ALCOA/ALCOA+ attributes,
- A discussion of some of the key requirements of 21 CFR Part 11, and
- Insight into how the NETZSCH Proteus® software, including Proteus® Protect, handles these issues.