Data integrity - целостность данных по GAMP

1 - Background

The impact of record and data integrity issues can be significant on a regulated company. It can result in recalls of products, warning or untitled letters, import alerts, injunctions, seizures, Application Integrity Policy Invocations/legal action, and ultimately the potential for patient harm. These regulatory actions can also have a significant financial impact.

There has been increased regulatory focus on all aspects of data integrity, including publication of specific regulatory guidance on the topic, and increased number of citations in the area.

For the purposes of this Guide:

• Regulated data is information used for a regulated purpose or to support a regulated process.

• “Metadata is data that describes the attributes of other data, and provide context and meaning. Typically, these are data that describe the structure, data elements, inter-relationships, and other characteristics of data.” [1].

• A regulated record1 is a collection of regulated data (and any metadata necessary to provide meaning and context) with a specific GxP purpose, content, and meaning, and required by GxP regulations. Records include instructions as well as data and reports.

• “Data Integrity is defined as the extent to which all data are complete, consistent and accurate throughout the data life cycle.” [1]

• The integrity of records depends on the integrity of underlying data, and signatures executed to electronic records should be trustworthy and reliable. See Appendix D3.

  This Guide addresses paper records, electronic records, and hybrid situations, while encouraging a move away from hybrid situations, wherever practical.