A company recently received this 483 observation:
…. Laboratory records are deficient in that they do not include a complete record of all data obtained during testing. Electronic records are used, but they do not meet requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.
Specifically, the firm maintains an electronic registry using a Microsoft Excel spreadsheet to document and keep track of the issuance for various logbooks used in laboratory operations, but this registry does not have audit trail features and is not able to track changes made to the spreadsheet such as modification or deletion. During the review of the master registry (Master Logbook), I observed the firm only made one entry for the issuance of multiple logbooks including but not limited to instrument’s usage logbooks for balances, HPLC systems, NMR, pH meter, and the 2019 stability samples receipt logbook.
For more observations pertaining to laboratory controls see Issue 1035 available today. It also has observations pertaining to manufacturing controls, laboratory controls and medical device manufacturing controls.