Equipment qualification user requirement specification

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. 

The setting up, adjustment and testing of equipment or a system to ensure that it meets all the requirements, as specified in the user requirement specification, and capacities as specified by the designer or developer. Commissioning is carried out before qualification and validation. 

A risk assessment can be used quite naturally in the process of drafting a User Requirements Specification (URS) for equipment utilities. By clarifying the intended use of the equipment and investigating the hazards, their possible causes and ways to control them in the actual context, the URS will be a fine starting point for purchasing and for the subsequent qualification. The risk assessment is to be updated as sorai as actual brands and types of a specific piece of equipment have been chosen. As a conclusion a level of risk can be determined for specific equipment, placed in specific locations and used for weU-defined purposes. If such a level of risk is determined for several pieces of equipment in a department, it may serve other purposes as well, for instance prioritising validadmi and frequency of maintenance or determination of the replacement period for specific equipment. 

This chapter is about the design, quality and application of equipment for the preparation of medicines in a pharmacy or for preparation in small scale pharmaceutical industry. The type of pharmaceutical equipment needed depends on the type of products to be produced, on the required productive capacity and the batch size. A list of essential and critical equipment for production and quality control must be included as attachment in the URS (User Requirements Specification) of any facility. In this chapter only equipment commonly used for preparation in pharmacies and small scale industry is discussed. The equipment, requirements, qualification methods, main applications, maintenance and cleaning procedures are described for ... 

The most important factors for the entire process of equipment qualification and computer system validation in analytical laboratories are proper planning, execution of qualification according to the plan, and documentation of the results. The process should start with the definition of the analytical technique and the development of user requirement and functional specifications. For computer systems, a formal vendor assessment should be made. This can be done through checklists and vendor documentation with internal and/or external references. For very complex systems, it should go through a vendor audit. 

Design qualification (DQ) covers setting of user requirements, as well as functional and performance specifications. Design qualification should ensure that the instrument has aU the necessary functions and performance criteria that will enable it to be successfully used for the intended application. Design qualification includes 1) Description of the intended use of the equipment 2) se-... 

Design Qualification (DQ) This provides documented verification that the design of the facilities, equipment, or systems meets the requirements of the user specifications and GMP. 

Design qualification (DQ) is the process used to determine a system that will function within the intended purpose. It can be compared to a user s requirements document for a piece of software. For example, if a CE is being purchased to run DNA sequencing samples, then the system purchased will need to include a fluorescence detector. The main vendors for CEs have similar options for their CE instruments reducing the utility of DQ protocols. Their main utility is to define the specific equipment needed for the purchase order. This only needs to be performed before the system is purchased initially. If desired, this can also be done when additional features need to be purchased (i.e., new detectors, etc.). 

Equipment validation is no different for ECM manufacturers than for any other device manufacturers. Each piece of equipment must be formally qualified through an installation (IQ) and operational qualification (OQ). The challenge for an ECM manufacturer may be that the equipment is specialized and custom built with none of the required equipment documents being available. The IQ requires written equipment specifications, a user s manual, lubrication requirements, spare parts, and safety features. Additional and perhaps unexpected time and costs are involved in equipment acquisition. 

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