Qualification system

Guidelines for auditing quality systems - qualification criteria of quality system auditors... 

The organization responsible for providing the NDE (VT, RT, UT, PT, or MT) shall be in compliance with ASTM E 1212 and ASME BPV Code Section V, Article 14 (Examination System Qualification). 

System qualifications are quality checks. They are a part of the validation of a product. Validation is defined as, Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes (5). A product that is validated is considered to be of much higher quality than one that is not validated. Automated dissolution systems need to be validated as a requirement of their use in regulated laboratories. 

There are several types of system qualifications. The quality of a system is dependent not only on the qualifications that are done following the system s development, but also on the qualifications that are done as part of the system s development. 

Specification, design, and code reviews are the earliest form of system qualifications. Quality cannot be tested into the... 

System qualifications are important for producing a high quality product. These tests occur throughout the entire life... 

Automated qualification software is yet another area of CDS development that has been affected by regulatory compliance. When you look at today s CDS solutions, it is typical to see the system providing direct digital control of the instrumentation. Many CDS manufacturers offer software tools that are capable of automating the installation qualification (IQ) and operational qualification (OQ) process. In addition, some manufacturers also offer software that can automate the performance qualification (PQ) for the various forms of instrumentation that it is capable of controlling. These automated software tools are not only time savers for the laboratory, but they also help to properly document the system qualification effort. 

System qualification Minor qualification needs as long as method/system reliable Qualification as part of larger system, and with more focus on long-term operation... 

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. 

Specifications are important to ensure proper selection of materials and serve as a reference for system qualification and maintenance. Information such as mill reports for stainless steel and reports of composition, ratings, and material handling capabilities for non-metallic substances should be reviewed for suitability and retained for reference. 

System qualification. Qualification protocols and the service to execute the qualification protocol may not be included in the cost of the instrument and have to be purchased separately from the instrument vendor. 

Caution should be used when putting together the user requirements since it will have a major impact on the amount of work required for the system qualifications. The more tasks that are specified in the user requirements, the more work has to be done during the qualification process to demonstrate that the instrument is capable of fulfilling the requirements. If the system is capable of performing additional tasks that are not required by the user requirements, there is no need to validate those tasks. 

The objective of this chapter is to examine computer system qualification as required for validation programs in the regulated pharmaceutical industry, providing guidance and reference on regulatory requirements, validation methodologies, and documentation. 

In the case of a computer system applied to a live manufacturing process and integral with plant equipment and the process itself, the project validation plan should specify the relationship of the computer system qualification activities and documentation with that of the corresponding plant equipment qualification and process validation. Indeed, the qualification activities and documentation of these elements of a computerized operation are sometimes combined. 

It is also important that the extent of the FAT is maximized. This will reduce the risk of problems arising during the final acceptance tests carried out on site and during system qualification. At this stage any dynamic testing considered for real-time computer process control systems will need to be undertaken utilizing simulation software, which in itself may need to be validated. 

On satisfactory completion of the computer system qualifications, with PQ conducted in conjunction with a successful process validation, a final report must be prepared by the pharmaceutical manufacturer s validation team. This is normally referred to as the validation report. The objective of the report is to give an overview of the results of the execution of the validation program for the computerized operation and to draw a conclusion as to the suitability of the computerized operation for pharmaceutical manufacturing. This may be unconditional use or there may be restrictions. In the latter case the proposed remedial ac-tion(s) must be approved and, as applicable, considered under change control. A schedule to complete any outstanding actions must be documented and progress formally reported. 

Chapter 10 covers the subject of computer systems qualification, including sample qualification using the GAMP software categories. 

To clarify the intent of 21 CFR Part 211.68, CPG5 7132a.07, I/O Checking was published in 1982. According to this CPG, computers I/Os must be tested for data accuracy as part of the computer system qualification and, after the qualification, as part of the computer system s ongoing verification program. 

The Hardware Installation Qualification Report can either be a standalone document or may be incorporated into the overall system qualifications summaiy report. 

If a validation plan is available, the system operational qualification should be addressed in this plan. If there is no validation plan, the system operational qualification plan may be addressed in either a standalone document or as part of the system qualification protocol. The system operational qualification plan identifies the activities to be completed and the responsible parties involved. 

The System Performance Qualification Summary Report can either be a standalone document or may be incorporated into the overall system qualification summary report. The approved System Performance Qualification Summary Report should be submitted for retention to the appropriate records retention organization. 

Documents associated with the system qualification and their results must be assembled and reviewed by appropriately qualified personnel following the review, by QA, and by the personnel appropriate for the level of criticality of the system. 

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