Technical Requirement Specification

During the software IQ the developer will produce a plan for installing the software in the target environment as specified by the technical requirements specification deliverable. The resources and information necessaiy to install the software product must be determined and be made available. The developer must assist the system owner and maintenance personnel with the setup activities where the installed software product is replacing an existing system, the developer must support any parallel operation activities required by the contract. The installation plan and procedures must be documented. 

Draft functional and technical requirements (Functional Requirement Specification, FRS and Technical Requirement Specification, TRS). 

Handbook 44, Specifications, Tolerances, and Other Technical Requirements Tor Weighing and Measuring Devices, National Institute of Standards and Technology, Gaithersburg, Md., 1996. 

The question of whether to use MAbs or PAbs in an assay is a matter of assay requirements (specificity and sensitivity) and economics and caimot be answered on technical merit alone. 

The question to answer for this pre-startup task is Who needs training for this process and to what level of detail One method to analyze training needs is offered by the Instructional Systems Design (ISD) technical training model. It points to the job task analysis method mentioned previously (Appendix D, ISD Model and Job Task Analysis Techniques) to identify procedure titles as a first step for determining which job positions require specific knowledge and skills. 

The technical requirements for such applications are highly specific, and the technology is also highly specialised and beyond the scope of this book. 

Technical Requirments - These will define the performance specifications for the equipment supplied. 

The Superfund Amendments and Reauthorization Act of 1986 reauthorized CERCLA to continue cleanup activities around the country. Several site-specific amendments, definitions, clarifications, and technical requirements were added to the legislation, including additional enforcement authorities. Title HI of SARA also authorized the Emergency Planning and Community Right-to-Know Act (EPCRA). 

The specific technical requirements within each category will depend upon the type of building and the use to which it will be put. For example, the requirements for fire escapes will be different for an office and for a factory. 

National Bureau of Standards Handbook 44 1979, Specifications, Tolerances and other Technical Requirements for Weighing and Measuring as adopted by the National Conference on Weights and Measures. NBS, Washington, DC, 1979... 

Prepare specifications for technical requirements of product and materials... 

It is not easy to develop such an overall picture, as we are trying to include a wide range of appliances, each of which has its own specific developments and technical requirements. To what extent these visions can be realized is still a matter for debate. 

ICH (1996). Technical Requirements for Registration of Pharmaceuticals for Human Use. Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals. S2A document recommended for adoption at step 4 of the ICH process on July 19, 1995. Federal Register 61 18198-18202, April 24, 1996. 

Step 2 Technical requirements Determine the specific technical requirements for the new method and/or analyzer that will ensure that it captures the previously determined business value. This is also done jointly by the customer and the project manager. Avoid nice to have and focus on what is necessary. Technical requirements may include accuracy, precision, specificity, turnaround time, response time, robusmess, maintenance needs, etc. They should be focused on what the analyzer needs to do (e.g. determine the concentration of component X with 1.5% relative precision, once a minute, in a corrosive process stream at 80 °C), not how it will be done. Issues that need to be considered in setting technical requirements are discussed in Section 15.2.3. 

General Safety Precautions. The preparation and handling of the items covered by this specification, and the subassemblies thereof, involve hazardous operations and therefore require explosives safety precautions. Use of this specification will not be construed as to relieve the contractor or manufacturer of responsibility for the safety of his operations. Listed below are certain minimum provisions which a contractor or manufacturer (who prepares the item covered) should observe in order to fulfill his responsibility for safety. At Bureau of Naval Weapons, Navy Department, and other government plants, these provisions are mandatory. Such other warnings and precautions, pertinent to the operational effectiveness or safety during preparation of the specified items, are included in detailed technical requirements of the specification... 

ASTM D 5289111 for rotorless curemeters, although rather more specific, is overall very similar to ISO 6502 in technical requirements. The British standard"2 is identical to ISO 6502. 

Technical grade chlorobenzene intended for use by US Dept of Defense as a solvent or as a raw material in the manuf of various chemicals, shall meet the following requirements specific gravity 1.101 1.112 at 20/4° acidity, as HC1 0.015%) moisture 0.1% and distillation range 131 32° at 760 mm Hg. Tests are described in... 

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. 

Provide a high level of confidence that the software code or configuration meets the defined operational and technical requirements of the system design specifications and the URS... 

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