Holistic validation

Following pre-installation qualification and the actual installation of an HPLC system, both the IQ and the OQ protocols should be implemented, back to back, soon after the installation. Again, the IQ is used to verify that the installation of the system was successful, with all instrument components powering-up properly. The OQ follows, verifying that the system components perform as they were functionally specified by the vendor. Finally, the PQ protocol serves to verify that the system as a whole performs to the URS established by the user and within the functional limitations of the system as a whole. As part of the PQ, it is recommended to test the system as a whole, called holistic validation. This... 

Therefore the authors introduced the concept of holistic validation where the whole chromatographic system was also qualified to evaluate the performance of the system. The concept of holistic qualification is important as some laboratories operate with a policy of modular equipment purchase. Here they select components with the best or optimum performance from any manufacturer. Furthermore, some of these laboratories may swap components when they malfunction. Thus, over time the composition of a system may change. Therefore, to assure themselves and any regulatory bodies that the system continues to function correctly, holistic qualification is vital. 

Validation of instrument hardware includes testing according to documented specifications. If HPLC instruments consist of several modules, individual modules (modular validation), as well as the entire system (holistic validation), should be validated. However, the latter is preferred, as individual module tests should be performed as part of the diagnosis if the system fails. 

Although thoroughly validated, really holistic system approaches are not immediately available it is possible today to significantly improve present agricultural systems by enhancing the knowledge of the multifarious aspects of agricultural... 

Regarding OQ validation, if one has only an isocratic pump available, it is recommended that one does not perform a detector linearity test at this time. However, this test can be subsequently performed as part of either the PQ validation or individual method validation, both of which typically test the performance of the system as a whole (holistically). 

The following is provided as an example of a holistic PQ validation protocol and is recommended as a guideline ... 

FIGURE 10 Example of an experimental sequence for holistic PQ validation on an HPLC... 

The computer system attached to the instrument provides instrument control, data acquisition, data processing, and reporting. According to the draft Analytical Instrument Qualification chapter of the United States Pharmacopoeia (USP) <1058> The manufacturer should perform design qualification, validate the software and provide users with a summary of the validation. At the user site, holistic qualification that involves the entire instrument and software system is more efficient than modular validation of the software alone. Therefore the user qualifies the instrument control, data acquisition and processing software by qualifying the instrument. ... 

Furman et al. discussing the validation of computerised liquid chromatographic systems, present the concept of modular and holistic qualification. Modular qualification involves the individual components of a system such as pump, autosampler, column heater and detector of an HPLC. The authors make the point that ... 

Holistic Approach. The PDA report [1] proposes a holistic approach to the validation in which means and variances of the blend are compared to the means and variances of the final product. The validation is considered successful if all criteria are met for both the blend and the final dosage form. If the final... 

There is no reason why the previous result should not be valid for all holistic systems, which accordingly are predicted to exclude the electromagnetic field6. It may well be the case for protons, and perhaps for atomic nuclei, but clearly not for atoms, in which case the electronic energy is determined by coulombic interaction. Another intriguing possibility is that the gravitational field may disappear at short range for the same reason. 

The fitness for purpose of a proposed solution should be assessed and any history of usage in similar applications considered when determining the validation strategy. A holistic perspective should be taken with computer systems comprising components found in multiple categories of software and hardware. 

The type and degree of validation of a computerized analytical system depends on its complexity. For example, the functions of a simple, computer-controlled system, with little or no flexibility regarding data input or evaluation, can be verified by execnting holistic tests and by comparing the test results with anticipated results. On the other hand, a more complicated compnterized system with on-line databases and extensive flexible data evalnation requires complex validation. 

Huot, Brian. 1993. The influence of holistic scoring procedures on reading and rating student essays. In Validating holistic scoring for writing assessment Theoretical and empirical foundations, edited by Michael Williamson and Brian Huot, 206-236. Cresskill, NJ Hampton Press. 

O Neill, Peggy. 2003. Moving beyond holistic scoring through validity inquiry. Journal of Writing Assessment 1 (1) 47-65. 

Method development scientists should not start the validation process unless they are confident of success. The validation process is confirmation that the method is suited for its intended purpose there should be very few surprises in validation results, because prevalidation evaluation data should suggest that the method will validate successfully. Method validation is also a holistic process that requires suitable instrumentation and competence in laboratory techniques to insure success. 

As can be seen, validation is a holistic approach where the validity of the model is based on many difference aspects. The guidelines presented by McLeod (1982) can be generalized into the following validity checks ... 

The term validation is often misunderstood by IT professionals not familiar with pharmaceutical industry terminology. Validation has often erroneously been seen as limited to a testing activity at the end of a software/ hardware project. Validation in the pharmaceutical industry is closely aligned to the principle of quality assurance, which is a holistic approach that aims to build quality attributes into a system rather than verifying quality through testing. A system that is built according to... 

One can discriminate between local form error (here would be more precise local form deviation ) and form error which is valid holistically for the entire feature (Humieimy et al. 2001). 

Many modified schemas already have been presented based on the V model in different variations. It is about an iterative and holistic process. For sake of brevity, the different phases will not be detailed. Practical recommendation to requirement engineering and management is provided by appropriate literature [34, 35], functional analysis in SE addresses the transformations to be performed in order to obtained required systems outputs from available inputs [36]. Elements of functional analysis have been presented among others by Buede [36] and systems integration [37, 38], verification and validation as well as testing also have been addressed by a multitude of scientific works [39]. 

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