Information Technology Quality Assurance

The Good Automated Manufacturing Practices (GAMP) Forum has developed guidelines for computer validation [5] and a draft guidance on quality assurance of information technology (IT) infrastructure [6]. 

When using medical laboratories, physicians frequently assume that the results provided are accurate and precise. Those working in the laboratory environment know that this is true only within the constraints of the methods, technology and processes available. In this chapter we will explore how internal quality control (IQC) and external quality assurance (EQA) procedures can inform both the analyst and the physician about the limitations of laboratory testing and permit a more intelligent use of laboratory data, while at the same time indicating areas where improvement is required. 

The integrity of the information managed by a computer system is protected by procedural controls, rather than the technology used to apply the controls. Procedural controls comprise any measures taken to provide appropriate instructions for each aspect of system development, operations, calibration, and validation. For computer systems, procedural controls address all aspects of software engineering, software quality assurance, and operation. In a regulated environment, these controls are fundamental to the operation of the computer system. 

A series which presents the current state of the art in chosen areas of oils and fats chemistiy, including its relevance to the food and pharmaceutical industries. Written at professional and reference level, it is directed at chemists and technologists working in oils and fats processing, the food industry, the oleo-chemicals industry and the pharmaceutical industry, at analytical chemists and quality assurance personnel, and at lipid chemists in academic research laboratories. Each volume in the series provides an accessible source of information on the science and technology of a particular area. 

It is quite important to know the pore size of the silica gel (which controls surface area), the amount of liquid phase or functional groups bonded to the silica, the type of derivatization reagent (mono- or trifunctional), and the extent of endcapping. This information was realized by some of the manufacturers of SPE products thus, they supply customers with quality control and quality assurance (QA) data of their SPE products. Figure 2.8 shows an example of such a QA report from 1ST (International Sorbent Technology). 

In general, the validation process should also be dehned by several SOPs, originating in either the regulatory or information technology groups. Table 3.2 shows a sample list of IT or Quality Assurance SOPs appropriate to the task. The validation process generally will consist of the following ... 

Definition of the system user requirements, system requirements, and software description Organization and responsibilities of the validation team (usually the end user, and the information technology and quality assurance members)... 

In contrast, ACR emphasizes the quality control, calibration of the equipment, and technology used in the procedures, and accordingly has developed three modules - module 1 for oncology, module 2 for brain, and module 3 for heart. A PET center must apply for all modules that are performed at the facility. For accreditation, the facility is required to submit information on the quality control and quality assurance program, data collection, reporting, radiopharmaceuticals procedures, and laboratory safety, along with chnical and approved phantom images. So, all equipment in a PET center is required to be calibrated and tested for accurate functionahty for accreditation by ACR. 

---