Life cycle stages process control

A checklist analysis (CCPS, 1992) verifies the status of a system. It is versatile, easy and applicable at any life-cycle stage of a process. It is primarily used to show compliance with standards and practices by cost-effectively identifying hazards, chlorine Tar> <- liccklists provide commonality for management K.-, icw of hazard assessments. It may be used for controlling a proces.s from development to decommissioning. Approvals by appropriate authorities Cl i( V each stage of a project. 

Computer Systems Validation (CSV) The formal assessment and reporting of quality and performance measures for all the life-cycle stages of software and system development, its implementation, qualification and acceptance, operation, modification, requalification, maintenance, and retirement, such that the user has a high level of confidence in the integrity of both the processes executed within the controlling computer system(s), and in those processes controlled by and/or linked to the computer system(s), within the prescribed operating environments) (MCA). 

Design of the experiment and scale-up. It is at this stage of the product s life cycle that many control parameters are evaluated (e.g., glass container in lieu of stainless steel, temperature controls). Information should be collected at critical processing stages and included in the master production record. This information will be used to assist in scale-up activities. 

There are several sections of the CFR that address the control of documents. Obviously, documentation supporting each phase of the life cycle of the master production record should be maintained under change control. A change control program at these early stages will verify that appropriate departments are part of the review process and that changes are not made without sufficient data support. 

Further control parameters for the processing of the product are evaluated or established during the scale-up activities. Document any problems encountered during this stage, as well as the resolutions taken to overcome them. The actions taken to resolve these problems may be indicative of items or data that you should strongly consider including in the master production record. If these parameters are controlled or data are collected, then problems encountered in the future can be more easily resolved. These control parameters are utilized in the next phase of the batch record life cycle—validation. 

At this step, validation of the process serves as the means of setting and/or evaluating control parameters as established during experimentation, development activities, and scale-up. The purpose of validation is to verify or authenticate that the process is capable of reproduction with results within specified parameters. Part of this validation is to collect data over the various processing stages. The validation protocol should be based upon data and information collected during the development activities of the product s life cycle. 

Materials science is currently witnessing an impressive acceleration of activities. New advanced materials are constantly emerging. The materials that will be used or needed in the next decade are not yet known. Since such materials are often used in special environments or under extreme conditions of temperature and pressure, their careful characterization must be done not only at the early stage of their development but also in their entire life cycle. Furthermore, their properties as a function of temperature and pressure must be well established for the optimal control of their processability. Undoubtedly, thermal and calorimetric techniques are essential in this respect. In relating thermal as well as mechanical behavior to materials structures, these techniques are perfectly adapted to provide accurate data in wide ranges of temperature and pressure. 

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