A company recently received this 483 observation:
….. Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Specifically, the warehouse management systems used for the receiving and distribution of raw materials, components and finished drug products such as … and the … were not validated for its intended use. There is no assurance that information inputted into the systems are reliable or prevented from deletion or alteration.
For more observations pertaining to data integrity, see Issue 1044 available today. It also has observations pertaining to lab controls, manufacturing controls, and medical devices.