Validation of the Plan

After the new distribution center processes and layout were developed, the company and the consultant wanted to prove the distribution center operating plan. Given the capital investment requirement of 25 million, the complexity and sophistication of the planned operation and the mission-critical nature of the new DC, the decision was made to validate the plan using computer simulation. 

Automated pallet double stacking and stretch wrapping in the manufacturing plant 

Automated pallet label application, trailer loading, DC storage location assignment, and pallet transfer to the DC 

Automated pallet unloading from the trailer onto the powered pallet-conveyor system and diverting into the drop-off station opposite the system-assigned putaway aisle 

System-directed putaway into the VNA location and confirmation of the transaction 

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In this theorem, any proposition p can represent an operator (i.e., an operation step), whereas the situations t and s represent any intermediate state of the process. Although the validity of the theorem is general, its practical utility is confined to monotonic planning with STRIPS-like operators. For example, in nonmonotonic planning the plans are at any point when partially specified and a new mechanism is needed to guarantee that when the partial plan is completed, a given proposition (i.e., a given operation) is still true (i.e., consistent). 

In this example the validity is crucial for the choice of alternative BOMs. Validity intervals are none intersecting. The most left and right interval (may be the same if only one exists) are extended to cover the parts of the planning horizon where no specific recipes are defined. 

To explore the validity of the ring formation strategy, we drew up plans and carried out an enantioselective synthesis of diene 77 (Scheme 19). Initially, based on previous studies on similar medium- and large-ring syntheses, we surmised that elevated temperatures would be necessary for effective macrocycliza-... 

Clinical investigations must be performed on the basis of an appropriate plan of investigation reflecting the latest scientific and technical knowledge and defined in such a way as to confirm or refute the manufacturer s claims for fhe device fhese investigations must include an adequate number of observations to guarantee the scientific validity of the conclusions. ... 

A specific, detailed description of the bioanalytical method should be written. This can be in the form of a protocol, study plan, report, and/or standard operating procedure (SOP). All experiments used to make claims or draw conclusions about the validity of the method should be presented in a report (method validation report). 

Instruments to be used in a GMP environment have to be validated prior to regular use. It is useful to develop the instrument implementation plan as a plan to outline the steps necessary to validate the instrument and to support the use of the instrument through its functional life in the laboratories. The implementation plan should highlight the activities in the validation of the system and will be the guiding document of the project. Typically, the validation plan includes ... 

The primary focus during validation is validation of the content of the spreadsheet itself. Nevertheless, items such as location of storage, security of cells and file, as well as access to the file have to be taken into account. The general validation approach for spreadsheets is not different from other validation approaches and can be arranged in three general sections (1) validation plan, (2) execution of the plan, and (3) validation documentation (protocol). 

This validation plan describes the prospective validation of the file Template Content Uniformity by UV (V.Ol).xls. The file is located at Drive E Validated Excel templates Template CU UV (V.01).xls. 

A validation plan should describe the purpose and level of the plan and must be consistent with established policies and the GMP risk and criticality analysis. The document must be approved and state the period after which the plan is to be reviewed. 

The periodic review report(s) should be retained in the validation file as a record of the computer system validation of the validation status and the validation plan should be updated with a date for the next review. 

User acceptance of the results obtained is often the key barrier to successfully employing operations research methods in strategic planning (cf. Pooley 1994, p. 120). As amongst others Bramel and Simchi-Levi (1997, p. 262) and Billington and Davis (1992, p. 592) point out, a validation of the cost functions integrated into the model is critical to ensure acceptance by top management. 

The validation plan is a strategic document that should state what is to be done, the scope of approach, the schedule of validation activities, and tasks to be performed. The plan should also state who is responsible for performing each validation activity. The plan should be reviewed and approved by designated management.1... 

Validation plans must be reviewed and approved by the author, the organization owning the execution of the plan, and by the system owner, because they will take the responsibility for the plan. 

The review and approval of the plan by QA is optional, but will provide an endorsement that the plan conforms to the current written procedures on computer systems validation, and that the document incorporates applicable regulatory requirements. 

When the analytical laboratory is not responsible for sampling, the quality management system often does not even take these weak links in the analytical process into account. Furthermore, if sample preparation (extraction, cleanup, etc.) has not been carried out carefully, even the most advanced, quality-controlled analytical instruments and sophisticated computer techniques cannot prevent the results of the analysis from being called into question. Finally, unless the interpretation and evaluation of results are underpinned by solid statistical data, the significance of these results is unclear, which in turn greatly undermines their merit. We therefore believe that quality control and quality assurance should involve all the steps of chemical analysis as an integral process, of which the validation of the analytical methods is merely one step, albeit an important one. In laboratory practice, quality criteria should address the rationality of the sampling plan, validation of methods, instruments and laboratory procedures, the reliability of identifications, the accuracy and precision of measured concentrations, and the comparability of laboratory results with relevant information produced earlier or elsewhere. 

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