Systems supplier

A group of computers becomes a network when intercomputer communication is estabhshed. Prior to the 1980s, all system suppliers used proprietaiy protocols to network their systems. Ad hoc approaches were sometimes used to connect third-pai ty equipment, which was not cost-effective in system maintenance, upgrade, and expansion. The recent introduction of standardized protocols has led to a decrease in initial capital cost. Most current DCS network protocol designs are based on the ISO-OSI seven-laver model. 

Slurry dispense system suppliers Dispense engine... 

The established methodology for computer system validation enables identification and control of each life-cycle phase and its associated document deliverables. It is also recognized that throughout the validation life cycle there is a level of dependency on the methods, services, and resources of the computer system supplier. 

The process for implementation and prospective validation of computer systems outlined in Figure 3 depicts the system application activities within each life-cycle phase and identifies key issues and considerations for each step. The process includes for evaluation of both the computer system product and the system supplier s working methods. The same life-cycle approach may be applied to validate the associated control and monitoring instrumentation [9]. 

As applicable, the project engineering contractor and the system supplier/ integrator can expect to participate on the project validation team at the appropriate time. The purchasing/contracts groups may also be involved and play a key role in administering contractual validation activities and documentation. 

To support the validation program the computer system supplier s plan should identify which supplier procedures are to be followed for ... 

Provide information for the system supplier s functional design specification (FDS)... 

The computer system URS needs to describe the levels of functionality and operability required from the computer system, its application, and the location with regard to the process. Definition of approved and accurate manufacturing and process data is a key objective of the URS and is essential in order for the computer system supplier or integrator to fully understand and develop the computer application and to engineer the field instrumentation and electrical controls. This must include the quality-related critical parameters that are fundamental in determining and ensuring the satisfactory quality of a drug product. Parameters, data, and functions that are necessary to uphold GMP must always be considered as firm requirements and candidates for validation. 

Pharmaceutical manufacturers expect the computer system supplier or integrator to understand the needs and constraints of the GMP environment. The fundamental requirement is for the system supplier to ensure that no assumptions are made with respect to the accuracy and dependability of the system. For this, the following need to be addressed ... 

Selection of the computer system and system supplier involves evaluation of a supplier s development and project working methods, and also initial evaluation of the basic system software and hardware functionality with regard to GMP application. 

Clearly define what is required from the computer system supplier... 

The computer system supplier s detailed project and quality plan incorporating the procedures for software quality assurance should be one of the first contracted deliverables, if not already submitted as part of the quotation or requested during precontract discussions. 

The software design specification is written by the system supplier and must identify how the supplier intends to provide system software under a software quality assurance plan. The design specification must describe the subsystem software that will make up the computer system software and subsystem interfaces to implement the aims set out in the FDS. Each subsystem should be traceable back to statements in the FDS. 

The pharmaceutical manufacturer is responsible for maintaining the validation file and must ensure the computer system supplier(s) documentation is also up to date. The validation file document set must be under document control at all times, and is normally located in the pharmaceutical manufacturer s quality system to ensure controlled and expedient access at all times. 

Normal operation—The computer system is maintained in accordance with the planned preventative maintenance schedule. Typical activities include recalibrating field instrumentation and computer I/O cards in accordance with site calibration procedures, running system diagnostics, checking operator logs for any abnormalities, and planning service visits by the system supplier. 

Abnormal operation—A failure occurs with the computer system or with the measurement and control instrumentation and an emergency repair is carried out either by site engineering or by the system supplier under the terms of the support agreement. In emergencies, immediate action may be authorized by the production department in conjunction with quality assurance, the problem, the action taken, and the updating of all affected documentation recorded retrospectively for change control assessment. 

For changes to the computer system, appropriate representation from both the pharmaceutical manufacturer and the computer system supplier should be considered. The pharmaceutical manufacturer remains responsible for ensuring that the validation status of the system is maintained. 

Before deciding on an escrow account, the legal department of the pharmaceutical company must clearly communicate to the computer system supplier the source code access requirements expected. Organizations should not require source code availability for the following software operating systems and system software, instmments and controllers, and standard software packages. 

Any additional information that may help the computer system supplier/developer to provide a quotation can be provided as appendices... 

It is most important to realize that at this time the full properties of the material are not yet developed, and the molded polyurethane has to be returned to the curing oven for the period recommended by the system supplier. The curing time varies depending on the chemistry of the system. The maximum properties of the cast polyurethanes are developed after a further 1 to 2 weeks at ambient temperature. 

There are numerous commercially available CMP wastewater treatment system technologies on the market today. All of the system suppliers strive for cost-effective trace metals removal and maximum water recovery, but may differ on how they address solids control and oxidizer removal. It is a... 

The validation life-cycle approach applies to both in-house developed and purchased computer systems. Supplier responsibilities are indicated later in this chapter. Suppliers include internal development or support groups, external vendors, and outsource organizations. 

Suppliers usually make sure their products are backward compatible so that legacy systems can be seamlessly replaced by new systems. Suppliers typically develop their upgrades for use on the same hardware platform. Full compatibility, however, is more than this. The new product must... 

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