User Requirements Specification

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)... 

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. 

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 ... 

User requirement specification (URS)—documented definition of the project. 

FIGURE 1 Validation phases. URS user requirement specification FRS functional requirement specification DQ, IQ, OQ, PQ design, installation, operational, and performance qualifications SOP standard operating procedure. 

The terms instrument qualification and instrument validation are sometimes used indiscriminately. In this chapter, the term qualification refers to the site preparation and the testing employed to demonstrate that the instrument is properly installed in a suitable environment and the performance meets the predetermined specifications for its intended use. Qualification is a part of the whole validation life cycle. Validation refers to the process to provide assurance that the instrument is suitable for the intended application throughout the lifetime of the instrument. Installation qualification (IQ), operation qualification (OQ), and performance qualification (PQ) are performed to provide evidence that the user requirement specifications (URSs), functional requirement specifications (FRSs), and design qualification (DQs) have been met. The sequence of requirements setting and qualification events as well as the relationships between IQ, OQ, PQ and URS, FRS, and DQ are generally illustrated by the V diagram shown in Figure 2. Installation qualification demonstrates the fulfillment of the DQ. Similarly, OQ demonstrates the fulfillment of the functional requirements and PQ demonstrates the fulfillment of the user requirements. 

A computer system is composed of software and hardware, equipment, a processor, and a user, and it is used to execute a specific procedure. Regardless of whether the computer system is developed in-house or by a contractor or purchased off the shelf, establishing documented end-user requirements is extremely important for computer systems validation. Without first establishing end-user needs and intended use, it is virtually impossible to confirm that the system can consistently meet them. Once established, it should obtain evidence that the computer system implements those needs correctly and that they are traceable to system design requirements and specifications. It is important that the end-user requirements specifications take into account predicate rules [12]. 

Qualification of equipment and validation of computer systems are not one-time events. They start with the definition of the product or project and setting user requirement specifications and cover the vendor selection process, installation, initial operation, ongoing use, and change control. 

Specify requirements and include them in your user requirement specifications document. Information on the requirements can be obtained from the regulation itself and from Part 11 industry guidance documents. 

Specifications are missing or are not followed. The most important part of validation is to write specifications. They include user requirement specifications... 

Design qualification document consisting of user requirement specifications (URS) and functional specifications (FS) [URS and FS can be combined into one system requirement specifications document (SRS)]... 

For example, at the highest level, conformance to the user requirements specification may be verified through data generated in house, through limited laboratory trials or through use of the full lUPAC harmonised protocol. What is critical here is the confirmation of the original user requirements under appropriate performance conditions (Figure 2). 

Figure 2 Mapping the user requirements specification to fitness for purpose...

The literature contains examples of collaborative trials that only prove that the method was not fit for its intended purpose The full lUPAC harmonised protocol is by its very nature an extensive and expensive exercise. From an economic perspective such trials should only be undertaken when there is good and well-documented evidence that it is likely that the method under evaluation is sufficiently robust. Investment of time and intellectual effort in method selection and the other aspects of the user requirements specification will pay great dividends. Prevention is better and nearly always cheaper than cure. 

The most important aspect here is that these questions have been asked and documented answers given as part of the User Requirements Specification. 

Figure 5 Content user requirement specification (URS) design qualification.

User requirement specifications cover more aspects than only the GMP requirement, because the URS is not written only for the validation procedure in fact, a URS is a very important project document covering technical as well as economic requirements of the technical system. Pharmaceutical manufacturing departments not only check the GMP aspects of a system additionally, following good engineering practice they will review the technical and economic aspects of a technical system. Obviously, the more experience a company gains, the more comprehensive a URS become. Past experiences such as project faults, inefficient technical systems, and bad commissioning can be included in a URS. 

Manufacturing Process Description Quality Critical Parameters User Requirement Specification Supplier Audit(s)... 

In business terms, auditing of software developers will allow you to assess the vendor s technical competence, vendor reaction to your company s user requirements specification (URS), vendor QA system adequacy, supplier experience with GXP systems, and quality level of vendor-prepared validation and qualification protocols. In short, vendor auditing is a regulatory expectation and auditing provides a means of assessing the supplier s ability to deliver a validatable system that will achieve the requirements of your company s URS. 

User requirements specification—The URS is an overview of the system functionally from the perspective of the end users needs. This document is often the first document generated to kick off a new CRS design and implementation project. It can be drafted early on by a... 

User Requirement Specification (URS) is a basic description of the equipment covering the purpose for which it is required. 

Supplier Forum (2000), User Requirements Specifications — Guidance Notes on the Preparation, available through GAMP Forum (www.ispe.org). 

The steps in the validation life cycle are not necessarily executed in the order indicated. Rather, the steps are usually executed as an iterative process in which various functions may be carried out concurrently. If necessary, steps may be repeated. For instance, the Validation Master Plan may be developed after, or concurrently with, the User Requirements Specification (URS) rather than before, as indicated. Equally, a Supplier Audit often involves a series of steps that may not be complete until well into the validation project. 

Create User Requirements Specification Conduct GxP Criticality Assessments Audit Supplier(s)... 

The information contained in User Requirements Specifications is often used to help determine the basic approach to validation to be taken for individual projects. Guidance on the scope of validation required for different types of computer systems is defined at the beginning of this chapter. A rationale must always be given supporting any validation decisions made during a validation project in the form of a separate document or included within the Validation Plan. 

User Requirement Specifications describe the user s functionahty requirements, level of user interaction, interfaces with other systems and equipment, the operating enviromnent, and any constraints. Specific regulatory requirements should be included, e.g., requirements regarding use of electronic records and electronic signatures. The documentation making up the URS should ... 

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