Data Corrections
Corrections must be made by crossing out the original data with a single line so it remains readable, and referenced with a note explaining the change. Correction ink is not allowed. Only personnel not involved in the original entry, usually QA, should make or approve corrections to ensure data integrity.
Data Logbooks
Logbooks must be clearly labeled with a unique ID, include the ID on every page, and record data in chronological order. They are used for non-batch records like equipment maintenance, calibration, temperature logs, and cleaning.
Logbook Uses
Logbooks are used to document non-batch-related activities essential for quality control and compliance. Common uses include recording equipment maintenance, calibration, temperature monitoring, equipment validation, part replacements such as air filters, and cleaning of rooms. This ensures all supporting processes are properly tracked and traceable.