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.
Specifically, you have not established a mechanism, policies, and procedures for control of electronic records and electronic source data to include storage devices and retention requirements. According to your HPLC system administrator, electronic records and data generated from your HPLCs is stored on the stand-alone computers and hard drives associated with each instrument and there is no back-up process or external device for data storage.
For more observations pertaining to data integrity see Issue 1028 available today. It also has observations pertaining to manufacturing controls, laboratory controls and medical device manufacturing controls.