There are a number of other definitions you should be aware of when dealing with electronic records and data integrity including:
- Audit Trails
- Critical Data
- Data Integrity
- Raw Data
- Relevant Data
- cGMP Data
Audit Trails
Audit Trails are a record of the date and time of operator entries and actions that create, modify, or delete electronic records. It should also be noted that these are expected to be secure and computer-generated; i.e., don’t rely on a user to provide an audit trail. (21 CRF 11.10(e)).
Critical Data
Critical Data is data with high risk to product quality or patient safety. (ISPE GAMP COP Annex 11 – Interpretation, July/August 2011)
Data Integrity
The property that data has not been altered in an unauthorized manner. Data integrity covers data in storage, during processing, and while in transit. (NIST SP 800-33)
Raw Data
Raw Data is all data on which quality decisions are based. (Eudralex Vol 4 Ch 4)
Relevant Data
Relevant Data is data concerning or possibly influencing the product’s reproducibility, identity, purity, labelling, efficiency or security.
GMP Data
Any data created as part of a cGMP record must be evaluated by the quality unit as part of release criteria and maintained for cGMP purposes
