Documentation system development

The principal equipment for the ultrasonic examination is the P-scan system, PS-4, which is a computerised ultrasonic system, developed by FORCE Institute, for automatic, mechanical and manual ultrasonic examination of welds and materials. The system has documentation and storage facilities for all data related to each inspection operation, and includes visualisation of the inspection results in the form of images of the material volume examined. 

On basis of developed criteria, the theoretical background of reference substances elaboration is developed, and also ai e developed procedures of elaboration and documentation system for the Ukrainian State Phamiacopoeia RS and for working RS of the phamiaceutical plants. These approaches ai e successfully applied to elaboration of RS for inter-laboratory testing. 

The quality system developed to meet the requirements of ISO/TS 16949 is likely to be a generic system, not specific to any particular product, project, or contract other than the range of products and services which your organization supplies. By implementing the policies and procedures of the documented quality system, product, project, or contract specific plans, procedures, specifications, etc. are generated. ISO 9001 contains a series of quality system requirements, not product quality requirements. For a given product, project, or contract there will be specific product, project, or contract requirements and it is these requirements to which this clause of the standard refers. 

Further discussion on electronic documentation systems can be found in the ISO 9000 Quality System Development Handbook hy David Hoyle (Butterworth-Heinemann, 1998). 

In addition, you may also want to revisit some of the flowcharts and other documentation you developed during systems design (Chapter 6). Training. Pilot participants must be properly trained otherwise the results of the pilot can be veiy misleading. Don t assume that you can defer training until later or that it doesn t pay to invest in training just to do a pilot. 

At this point the VP, ESH and his set of integration teams worked to develop the performance measures that would be used to assess both the success of the overall integration effort and Quality Chemical Company s performance in the areas of ESH and PSM. Some of the measures specific to documentation systems were ... 

Within the CQP concept we distinguish three parts (1) basic preparations, (2) CQP monitoring system development, and (3) documentation and verification development, all of which are explained in more detail below. 

Develop/Document System to Manage Chemical Reactivity Hazards... 

As far as possible, systems existing in a production mode prior to the effective date of the GALP standards, as well as purchased systems, should be docmnented in the same way as systems developed in accordance with the EPA System Design and Development Guidance and Section 7.9.2 of the GALPs. Documentation relevant to certain phases of the system fife cycle, such as validation, change control, acceptance testing, and maintenance, should be similar for all systems. 

In an agile iterative process, not all use case specifications need to be fully developed before the design and implementation starts. Usually, a scope and a vision document are developed with a fist of features that should be included in the system, including a brief description of each feature as in the Brief Description section of the above use case specification. These features are prioritized and planned according to their business values, complexity, and architectural significance (please see Chapter 5). At the beginning of an... 

It should be recognized that the URS is the base document for developing and testing the computer system and needs to provide clearly defined and measurable requirements. Authorities and responsibilities for provision of information for the URS must be stated in the project validation plan. 

Reduce exposure to loss of expertise and knowledge by documenting system application, design, development testing, problem resolution, and enhancements... 

Suppliers with system development and project execution procedures in line with validation life-cycle requirements are well placed to deliver the appropriate level of validation support documentation. The existence of supplier test... 

Documents that cannot easily fit into the validation file or may be required on a day-to-day basis (e.g., supplier system manuals, calibration schedule, and records) may be filed elsewhere, and these should be identified on the document schedule stating where they are located and identifying who is responsible for them. All documentation provided by the supplier must be suitably marked to easily identify its location in the validation file. It is acceptable to have the system development records archived by the supplier. If the pharmaceutical manufacturer requires the supplier to store and maintain the documents there needs to be a formal agreement on the retention period. 

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

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