Documentation system, designing

Documented process structure provides rapid employee assimilations when transferring employees between sites. New employees, replacing existing process owners, are enabled to rapidly execute process responsibilities due to the abbreviated learning curve when processes have been well defined and documented. Systems designed as described here provide meaningful and comparable metrics for leadership to evaluate progress, compliance, and performance. 

Requirements review documentation System design specifications Software design methods Software review(s)... 

Failure Mode and Effects Analysis. The system design activity usually emphasizes the attainment of performance objectives in a timely and cost-efficient fashion. The failure mode and effects analysis (FMEA) procedure considers the system from a failure point of view to determine how the product might fail. The terms design failure mode and effects analysis (DFMEA) and failure mode effects and criticaUty analysis (EMECA) also are used. This EMEA technique is used to identify and eliminate potential failure modes early in the design cycle, and its success is well documented (3,4). 

The ultimate responsibility for safety rests with me operating company OSHA 1910.119 is clear on this. Each company is expected to develop (and enforce) its own practices in the design, installation, testing, and maintenance of safety systems. Fortunately, some companies make these documents public. Monsanto s Safety System Design Practices was published in its entirety in the proceedings of the International Symposium and Workshop on Safe Chemical Process Automation, Houston, Texas, September 27-29, 1994 (available from... 

Search and retrieval system designed to direct the user to documented fiist-spil) incidents. No charge. 

Before the analyst begins fault tree construction, it is necessary to document and understand System design,... 

Documentation of the system design and operating data, analytical assumptions and constraints used in the analysis in a notebook becomes part of the QA record. However, it is useful to have documents analyses and records as computer files for handling the voluminous data reporting and presenting the results of the work. It provides. 

Follow system design concepts, documentation needs and hazards analysis requirements—RP 14J. 

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. 

Software and computer systems that are subject to validation must be designed using strict procedures with sufficient documentation. During the process of system design, strict controls must be in place to allow future validation success. The system designer must ensure that documentation of the system meets minimum requirements necessary to satisfy the needs of the validation team. 

The programming staff or IT department personnel should develop a software/computer system design description based upon the requirements document. This description should outline the specifics required in the system, including security... 

For every Customer we know about businesswise, there is a Person in the System Design. We ve shown the relationship as the association abs. There are similar direct correspondences for several other types. In fact, the whole business model is implemented by the whole system design, so we ve shown that association, too. (The outer type boxes are shown in gray to reduce clutter in Figure 10.26. In real documentation, you d show them separately.) So we can say that... 

Software—The programs, procedures, and related documentation associated with a system design and system operation. The system can be a computer system or a management system. 

For all new systems to be used in the conduct of an EPA study, laboratories must estabhsh and maintain documentation for aU steps of the system s fife cycle, in accordance with the EPA System Design and Development Guidance (June 1989) and Section 7.9.3 of the GALP standards. 

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. 

These three kinds of information, along with other supporting documentation, must be provided as evidence (logos) of the system design. The review that documentation, assuring its appropriateness, thoroughness, and the degree to which it was followed, provides the additional evidentiary support (ethos) for the system validation. 

Managerial control is estabhshed and documented through a series of SOPs. These SOPs are system design, use, and control pohcy statements. They summarize procedures of system security, disaster recovery, normal use, data archive and backup, error response, documentation, testing, and other important aspects of control. 

Manufacturers implementing a quality system that conforms to an existing standard may find it helpful to create a table or some other document that shows the relationship between cGMP requirements, requirements of the standard, and the element(s) of the manufacturer s quality system. Such a tool can help assure that all pertinent requirements are covered in the quality system design and that audit plans designs include assessment of all pertinent 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]. 

It is important to document the relief system design so that it can be taken into account in any future modifications. The documentation should normally include the following ... 

The official definition of quality is, the totality of features and characteristics of a product or service that bear upon its ability to satisfy stated or implied needs (ISO 8402). Well-planned design is one of the major contributing factors to achieving quality within a product or service. It is therefore necessary to carefully control critical elements of a company s documentation system with particular reference to each phase of design in order to ensure that the effects on the end products or services are not disastrous and are based on customer requirements. 

Quality-related critical parameters, data, and functions are essential for specification and contract considerations, system design and development, qualification testing of the computer system, and PQ for the validation of the process. GMP-related system requirements need to be traceable throughout the specification, design, development, testing, and operation of a system. This can readily be achieved by having a traceability matrix that will identify corresponding sections and data in the key life-cycle documents. 

It is recognized that the URS may be superseded by the FDS as the definitive specification for system design. The URS, however, remains the technical and operations statement of user requirements and must be maintained under change control as an up-to-date document throughout the life of the system. The URS also remains the base document against which PQ is verified, and once the URS is approved a PQ test plan can be generated. 

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