You must ensure that changes to computerized MPCRs or other records and input of laboratory data into computerized records be made only by authorized personnel. FDA recommends that whenever possible you should use technology to restrict the ability to alter specifications, process parameters or manufacturing and testing methods (e.g., limiting permissions to change settings or data).
An EQMS has numerous levels of security to automatically track and ensure the authenticity of each user in the system. The software tracks every signature combination and does not allow duplication or reassignment of the user ID and signature combination. All user IDs and passwords are encrypted and are not available to anyone in the system.
