The integrity of GMP data - part 2 of the new MHRA blog

To the MHRA, data integrity is a significant, high priority theme right now. Above and beyond the existing Data Integrity Guidelines, the MHRA developed a new blog on the theme in June.

Part 1 of the MHRA Good Manufacturing Practice (GMP) Data Integrity blog was subject in the news Integrity of GMP Data - New MHRA Blog!

The second blog went live on 16 July 2015. It is all about the design of systems with which the quality and integrity of data can be ensured. This applies to both paper and computerised systems.

A helpful, data-integrity-related acronym is ALCOA.
ALCOA stands for 'attributable', 'legible', 'contemporaneous', 'original' and 'accurate' as indicators of data administration system success. It includes the following aspects:

The identity of the person who made the entry must be unique and obvious.

It should not be possible to modify or restore records without an audit trail. And it is important not to forget paper records.

The records must be at the right place at the right time. This principle is illustrated using an example from the field of packaging operations.

The original data must preserve data accuracy, completeness, contents and meaning, including the meta data.

Recording the data automatically with the necessary IT controls guarantees better overall control. In cases where automation is not possible, real-time verification by a second employee for quality-relevant values may be necessary.

You will find the complete blog at MHRA blog Good Manufacturing Practice (GMP) data integrity-a-new-look-at-an-old-topic Part 2.

Source: MHRA, UK

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