Examples procedure control information

Figure 5-2. Procedure control information. This example shows a format for including the procedure control information in the procedure header and footer.

The instructions embedded in computer program(s) either provide information on what the operators are supposed to do, or information on how the equipment or processes are intended to function. For example, for manufacturing operations, the batch production and control records may provide procedures, controls, instructions, specifications, and precautions to be followed when using computer systems. These programs may also contain control data for product formulation, batch size, yields, and automated in-process sampling/testing procedures. 

By monitoring the validation status of the applied analytical procedure, for example, with control charts, reliable information on the long-term behavior of the procedure can be obtained and trends can be detected very early. Transferring in this way data to information to knowledge, the analytical system (or the production process) can be adjusted before problems such as OOS results occur (action instead of reaction). In analogy to equipment qualification, a continuous system is proposed design, operational, and performance validation (three Vs). 

There should be a control document or system specification. The control document should state the objectives of a proposed computer system, the data to be entered and stored, the flow of data, how it interacts with other systems and procedures, the information to be produced, the limits of any variable and the operating programme and test programme. (Examples of each document produced by the programme should be included.)... 

The second question concerns the quality of the chemical control, directed more at the chemical analysis proper and its procedure. Important factors here are sufficient specificity and accuracy together with a short analysis time. In connection with accuracy, we can possible consider the quantization of the analytical information obtainable. For instance, from the above example of titration, if we assume for the pH measurement an accuracy of 0.02, an uncertainty remains of 0.04 over a total range of 14.0, which means a gain in information of n1 = 14.0/0.04 = 350 (at least 8 bits) with an accuracy of 5% as a mean for the titration end-point establishment of both acids, the remaining uncertainty of 1% over a range of 2 x 100% means a gain in information of n2 = 200 (at least 7 bits), so that the two-dimensional presentation of this titration represents a quantity of information I = 2log nx n2 = 15 bits at least. 

Level II methods are those that are not unequivocal but are used to determine the concentration of an analyte at the level of interest, and to provide some structural information. For example, these methods may employ molecular, functional-group, or immunochemical properties as the basis of the analytical scheme. Hence, these methods are often reliable enough to be used as reference methods. Level II methods commonly separate the determinative from the identification procedures, and may also be used to corroborate the presence of a compound or class of compounds. Tims, a combination of two level II methods may provide attributes suitable for a level I method. The majority of analytical methods presently available and used by regulatory control agencies are level II methods. 

---