Design Qualification definition

Prioritization is removed at this stage because the FS represents what will be designed. This definition of the functionality defines the majority of the basis for Operational Qualification (OQ). 

System qualification is a process that ensures that an analyzer system is installed and operated according to requirements that are aligned with the intended use of the system. The commonly used approach in the pharmaceutical industry is the system life cycle or SLC process. In the SLC approach, the definition of intended use, design, configuration, installation and operation is linked and documented over the lifetime of a system. 

Since the definition of validation seems to vary from nation to nation, we will include all activities from design to final product, as well as individual validation, such as process validation [2] (product qualification in ISO). 

Equipment qualification typically entails installation qualification (IQ), to demonstrate that the equipment is indeed what was specified operational qualification (OQ), to demonstrate that the equipment performs acceptably over its design range and performance qualification (PQ), which demonstrates that the equipment renders consistent performance. No time will be spent providing formal definitions for these terms. 

Definition documentation Design/development documentation Qualification documentation Ongoing evaluation documentation System software System hardware... 

Most firms today start by qualifying each subsystem. To qualify, of course, means to establish convincing evidence that something happens as intended, which matches the validation definition (in more explicit terms, however). Installation qualification may be defined as documented verification that all key aspects of the installation adhere to manufacturer s recommendations, appropriate codes, and approved design intentions. Operational qualification is documented verification that a system or subsystem performs as intended throughout all specified operating ranges. 

Safety concerns may arise from the presence of impurities or contaminants. It is preferable to rely on purification processes to remove impurities and contaminants rather than to establish a preclinical testing program for their qualification. In all cases, the product should be sufficiently characterized to allow an appropriate design of preclinical safety studies. In general, the product that is used in the definitive pharmacology and toxicology studies should be comparable to the product proposed for the initial clinical studies. (ICH S6)... 

Implementation of the software design commences once the design is finalized. Sandpit (prototyping of application functionality) and development facilities are required to support system definition and development. A validation environment to perform qualification testing and a live environment completes the system development and operational architecture. 

From this definition it is obvious that packaging components come within the scope of validation (via the material route). In the context of the earlier review of quality of design and quality of conformance, it may seem that the validation concept does not offer a great deal of additional confidence. However, this would ignore the recent history of validation and its expansion into qualification. 

Vehicles designed or used to transport 9 to 15 passengers (includ-I ing the driver), not for direct compensation, are exempted from the definition of a commercial motor vehicle with respect to the driver qualification requirements. 

The qualification procedure specified for the isolation devices may lead to a definition of a standard and to the use of standardized products for seismic isolation design. 

N45.2.6-1973 Qualifications of inspection, examination and testing personnel for the construction phase of nuclear power plants QA-76-6 N45.2.10-1973 Quality assurance Terms and definitions QA-76-10 N45.2.11-1974 Quality assurance requirements for the design of nuclear... 

Site protection measures are discussed in Ref. [3] as part of the site qualification procedure and conditions affecting the definitions of the design basis flood itself. 

Uses experimental design procedures wherever possible in case of qualification taking advantage of computer-based optimisation software definition of validation protocol and experiments. 

Because this initial decomposition is so strongly linked to a specific industrial application and its associated qualification procedure it is not possible to provide an industry independent process. Nevertheless, a description is required of the major controlling parameters which make up the definition of the Real World Problem, such as loads, design critical factors etc. When these factors are examined it is clear that the process is one of finding a taxonomy which adequately defines the terms being addressed. To illustrate the points being made the specific case of deriving a basic definition of the loads is now considered. 

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