User requirements

Glacial acetic acid is considered to be 99.50 wt % or higher. A different grade has a minimum concentration of 99.70 wt %. Specialty users require water solutions of 86% and 36%. Such grades are prepared on special order. Only minor quantities of these grades are marketed, and their use is vanishing. 

Purchases of manganese ore are made on the basis of user requirements, individual specifications, and availabiUty. Most grades of manufactured manganese chemicals are subject to government and commercial specifications, many of which apply to specific uses. Prices of metallurgical manganese ore reached a high of 3.78/t in 1990 (Fig. 13). 

Most users require extensive composite qualification testing programs to assure acceptable end use product properties. The magnitude of the qualification depends entirely on the end use requirements and may range from extensive testing of laminates and final parts made from several production lots of fiber, to a single lot laminate evaluation or test coupon verification of properties. 

The modular design integrates, as far as possible, existing software from member states, to permit the free distribution of the package. Version 1.0 of PSAPACK was used in a IAEA international training course on PSA in safety decisions (1988). Since then, PSAPACK evolved in response to users requirements, and has been widely distributed. 

Do the design controls ensure that design reviews and design verification and validation are recorded and demonstrate the product meets the design input and user requirements ... 

Expressing the requirements in terms of requirements that can be verified and validated has two meanings. You need to be able to verify that both the design input requirements and user requirements (if different) have been achieved in the product so they need to be expressed in appropriate terms. The vehicle to contain such requirements is usually a product or service specification. You also need to be able to verify that the design output meets the design input and to achieve this you will need to document your calculations and analyses. 

These are commercially available off-the-shelf packages. They are used as is, with significant reliance placed on documentation provided by the developers to ensure that the package meets the user requirements specification (URS)... 

To gather and refine user requirements for an eventual production deployment... 

In addition, critical performance parameters, such as range, resolution, and user requirements, can help identify the appropriate equipment to be used for specific measuremenfs. Calibration dates/schedules, and also tiie sfafus of fhe insfrumenf and componenfs (active, out of tolerance, retired, or awaiting service), can be tracked. 

Upon management s approval, the end-user requirements for the software/computer system should be identified in a formal document that includes the following ... 

To enable development by distributed teams, work units must be separated and partitioned with clear dependencies, architectural conventions and rules must be explicit, and interfaces must be specified unambiguously. Components will get assembled by persons different from the developers, potentially long after they are built the relationships between the implementations, interface specifications, and eventual user requirements must be testable in a systematic way. 

The functional requirement specification (FRS) and its nearly identical twin, the user requirement specification (URS), is a list of functions and features the device should process. If there are specific needs the customer (user) has then this is the place to include it. The level of specificity may be dependent on the experience the end-user has with dissolution. An experienced dissolution scientist will be sensitive to issues such as cross-contamination or the importance of timing etc. Critical specifications need to be clearly stated since the FRS serves as the starting point of the test plan (discussed in the next section). 

User requirement specifications (URS) for the computerized system are provided by the pharmaceutical firm to the computer systems vendor. The vendor generates functional and design specifications as a basis for designing and coding software for the computerized system. The system is then built, together with all the interfaces to the hardware, and tested by the vendor. After installation of the computerized system, IQ, OQ, and PQ are performed at the pharmaceutical facility to verify that the system is able to meet the URS and design and functional specifications. 

Category 4—Configurable Software Packages These software packages can be conhgured according to user requirements. A supplier audit is usually required to conhrm software has been developed according to a documented quality system. Validation should ensure software meets URS requirements. Full life cycle vahdation is needed. 

Moving forward, one needs to establish what the user requirements should be for an HPLC system. These requirements are also referred to as user requirement specifications (URS—ISPE/GAMP) they will be subsequently referred to as URS throughout this chapter. Things to con-sider/include within the URS are ... 

As stated earlier, these tests should be designed to test that the HPLC system, in its entirety, is performing in accordance with the pre-approved user requirements (URS) for routine operation. Ultimately, the best way to do this is to test the system as holistically as possible. 

To this end the following guideline describes a general approach toward risk management for a laboratory instrument and then applies it to the performance of the operational qualification of a CE instrument. Tests then need to be devised in order to determine the suitability of the instrument for its intended use and to fulfill those user requirements that have been defined by the operator. 

The schematic arrangement of the MAS system is shown in Fig. 7.S. The autosampler will handle up to 40 samples which, when the parameters are defined, can be left to operate under computer control. The MAS system is configured complete to fit user requirements and includes both hardware and software facihties. 

Table 7.2 shows the control computer s operation in the Glaxo system. It can be seen that all aspects of the system can be initiated and tested before starting the analysis. The system is modular and can easily be configured according to users preferences. Data can be displayed in either a tabular format or as a graphical display, to suit user requirements. 

Increases in processor speeds and storage capacity allowed these system to acquire and process data rapidly. Many fourth-generation systems became nodes in laboratory computer UMS networks. They communicate with host computers to receive instructions for analyses and for transferring results. Programs and values of parameters for specific analytical methods can be stored in memory and recalled by the analyst as needed. While the analyst found interaction with these systems easier, he or she became further removed from the system components and often more dependent on the vendor s software. Tailoring requirements to individual user requirements was often not viable with this approach. 

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