A company recently received this 483 observation:
….. Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.
Specifically, management confirmed chromatographic data obtained prior to 10 years ago cannot be accessed due to upgrading of chromatographic software from … to …. This affects data supporting method and process validations.
21 CFR 211.180(c) and 211.180(d) state that records can be kept electronically but that there must be a way to read the records for their retention period.
For more observations pertaining to laboratory controls, see Issue #1053 available today. It also has observations pertaining to packaging and labeling, manufacturing controls, and medical devices.