System access authority check

Logical access controls for computer systems, including authority checks, form another security aspect. Authority checks are based on the various roles and responsibilities assigned to individuals known to the system. Computer systems must be designed to make distinctions between the controlled access (a) to the system, (b) to functions in the system, and (c) to input and output devices used by the system. 

Procedures and controls shall include use of authority checks to ensure that only authorized individuals can use the system, electronically sign a record, access the operation or computer system input or output device, alter a record, or perform the operation at hand. 

Access to computer system input or output device (Can input or output devices be altered without authority checks in a manner that will predictably affect results )... 

An assurance that the physical hardware, software, and the regulated electronic records are maintained in a secure environment is critical to the validated status of a computer system, particularly if it is an enterprise level system. Security must be instituted at several levels. Procedural controls must govern the physical access to computer systems (physical security). The access to individual computer system platforms is controlled by network specific security procedures (network security). Finally, application level security and associated authority checks control access to the computer system applications (applications security). 

The use of authority checks (Part 11.10(g)), when applicable, to determine if the identified individual has been authorized to use the system, and has the necessary access rights, operate a device, or to perform the operation required. 

Check security controls — system access and user authority checks. 

Access to the system is limited to authorized individuals — authority checks are automatically performed by the system. 

One problem is that electronic records are comprised of databases, which are dynamic, that is, the content changes as new information is added. Worse, data can be changed or deleted, with no evidence and in a manner that destroys the original data. System access must be limited to authorized individuals. There must be regular system checks. There must be time- and date-stamped audit trails. If changes are made in the database, the audit trail must show who made the changes, when, what the old and new values are, and why the data were modified. 

Main security solutions proposed to address security requirements of patient-monitoring systems reside in the areas of encryption and secure communication. Access-control techniques need to be developed to address the privacy issues in eHealth applications. In particular, procedures for authentication (user identification) and authorization (access right checking) are essential for acceptable and sustainable eHealth applications. The authentication function ensures that users are indeed who they claim to be. Therefore, an unauthorized party should not be able to receive or access a patient s medical data. Various techniques being considered include a combination of different authentication atomics. These atomics include biometric information (fingerprint, retina scan, typing pattern, etc.) and information the user knows (mother s maiden name), user possessions (e.g., smart card identification systems), and may also include current location and/or the end-user terminal identity (media access control [MAC] hardware address) and time of access. 

GMP risk assessment Qualified/trained resource System life-cycle validation System environment Current specifications Software quality assurance Formal testing/acceptance Data entry authorization Data plausibility checks Communication diagnostics Access security Batch release authority Formal procedures/contracts Change control Electronic data hardcopy Secure data storage Contingency/recovery plans Maintenance plans/records... 

Appropriate measures must be taken to ensure the validity of the sources for data and commands. Validation of the automatic interfaces, or a check of the input medium in the case of manual inputs, is performed as part of system validation. For example, if several sets of scales are connected to a network, only calibrated scales with the correct weighing range may be accessed. Similarly, it should only be possible to use radio scanners assigned to a particnlar dispensary for weighing raw materials. In addition, personal identification devices (e.g., company identity badges or ID cards that are used in conjunction with a password) should expire after a period and only be issned to authorized users. On expiry such devices should need formal renewal. 

Operational checks need to be in place to force sequential operations in the right order (Figure 16.3). This discipline is in place in many existing systems and is not seen as onerous or difficult. Operational checks are also demanded to ensure that users are authorized to carry out the activities. Again, these are widely practiced and traditionally controlled by means of hierarchical access procedures. 

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