Integrated Control Systems procedure

The following practices are applicable to the integrated computer system (which include the controlled process, operating procedures, and supporting documentation) that performs regulated operations ... 

The integrated computer system is qualified according to procedural controls... 

The integrity of the information managed by a computer system is protected by procedural controls, rather than the technology used to apply the controls. Procedural controls comprise any measures taken to provide appropriate instructions for each aspect of system development, operations, calibration, and validation. For computer systems, procedural controls address all aspects of software engineering, software quality assurance, and operation. In a regulated environment, these controls are fundamental to the operation of the computer system. 

Another important activity is the process to evaluate new security technologies and their integration with computer systems. The procedural controls implemented as a result of a risk analysis provide a starting point to look for technologies that can replace procedural controls. These procedural controls are the result of security-related implementation requirements identified during the risk analysis. 

The procedural controls applicable for the preventive maintenance and repair of the hardware provide a mechanism for anticipating problems and, as a consequence, possible loss of data. Modem hardware usually requires minimum maintenance because electronic circuit boards, for example, are usually easily replaced and cleaning may be limited to dust removal. Diagnostic software is usually available from the supplier to check the performance of the computer system and to isolate defective integrated circuits. Maintenance procedures should be included in the organization s standard operating procedures. The availability of spare parts and access to qualified service personnel are important for the smooth operation of the maintenance program. 

While we use conventional control systems here, our plantwide control design procedure does not preclude the use of MPC at a certain level. Our focus is on the issues arising from the operation of an integrated process. We find that a good control structure provides effective control, independent of any particular controller algorithm, while a poor one cannot be greatly improved with any algorithm (MPC or PID controllers). 

Failure to establish appropriate procedures to assure that computerized processing control systems and data storage systems are secure and managed to assure integrity of processes and data that could affect conformance to specifications. [FDA, 2001]... 

The calibration procedures adopted on-site must be agreed on with the customer and conform to recognized industry instrument calibration standards and the supplier s instructions. These procedures must be applied to all in-line instrumentation, loop instrumentation, local controllers, analyzers, and so on. Where the control and monitoring instrumentation is integrated with a computerized control system and where factory tests have been carried out, the installation calibration procedure should be agreed on with the customer. 

Electronic records include data-storing memory cards used in embedded control systems such as steam sterilizers. These cards are used to transfer data (critical parameters, cycle times, etc.) from the control system to a main database application which is usually networked. A memory card is about the size of a credit card. Manual installation, removal, and transfer of the memory cards must be conducted in accordance with defined procedures. Reuse of cards must be carefully considered data must not be deleted until confirmation is received that it has been successfully downloaded to the database. The local operating enviromnent and the possibility of EMl/ESD damage to data integrity of the memory card must also be evaluated. 

Virus protection activities defined in a policy and procedure for governing vims protection for SCADA systems include methods for checking automation system data and software integrity, e.g., standards and requirements for installing fixes/patches for known automation control system problems. Periodic assessment of automation control system vulnerabilities are to be undertaken in the light of emerging knowledge. 

Height calibration (z) Monoatomic steps on the Au(lll) surface and a nanogrid with defined z-height have proven to be good standards for the z-calibration of an STM. In many respects the calibration procedure for the vertical axis (z-axis) is comparable to that for the lateral axes, however, the vertical movements are often much faster (in order to follow the object s topography or more accurately its electronic contour), than in the lateral directions. In order to obtain accurate results, the parameters of the feedback control system (e.g. proportional factor P and integration time constant I), that influence the dynamic behavior of the SPM in z-direction, need to be adjusted... 

System and data security, data integrity and confidentiality through limited authorized system access. Procedures should be in place to limit the access to authorized users. Limited access must be ensured through physical and logical security mechanisms. Most companies already have similar procedures in place. Typically, users log onto a system with a user ID and password. Problems have been reported with practical implementation in analytical laboratories when computer controlled systems collect data over time. To prevent unauthorized access, a screen saver with password protection should be activated. 

The tuning procedure for a cascade control system is to tune the secondary controller first and then tune the primary controller with the secondary controller on automatic. As for the types of controller used, we often use a proportional controller in the secondary loop. Since it has only one tuning parameter, it is easy to tune. There is no need for integral action in the secondary controller because we don t care if there is offset in this loop. If we use a PI primary controller, the offset in the primary loop will be eliminated, which is our control objective. 

Periodic reviews should include an assessment of system performance, changes, authorized user access privileges, network integrity and operating procedures. Analysis equipment calibration results can be reviewed using statistical process control techniques to indicate the health of equipment. 

Lines operate with different degrees of automation via computer-integrated controls, providing improvements in operating procedures and quality assurance and reductions in costs. These closed-loop systems maintain long-term repeatability of factors such as melt velocity and pressure. This action occurs independently of what could be occurring with component wear, unbalanced equipment in the line, or plastic material variations. 

State of the art digital instrumentation and control systems and an advanced man-machine interface control room, console-type work stations, software controls and integrated, prioritized alarms and procedures ... 

C There is a comprehensive procedure quality control system which the operations team is an integral part of and which ensures that procedures are recalled and updated when there is any process, equipment, or staff change which necessitates it Procedures are managed and incorporated in the management of change process. The importance of operator involvement to encourage ownership and therefore active use of procedures is encouraged ... 

Integrated Management System. It includes procedures for documentation control, control of records and internal communication. It is interconnected with the rest of the system blocks. 

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