Documentaries defining

Validation Approach The project methodology to be followed for validation of LIMS must be clearly defined in the Validation Plan to ensure that the most efficient approach is taken. This document should provide the project team and the LIMS Suppfier/Integrator with sufficient detail to allow the appropriate documentary evidence to be produced to support the finally handed over compliant system. It is important that the Validation Plan (or at least the relevant information) be issued to the LIMS Supplier/Integrator to ensure that no surprises regarding the validation expectations occur at a later stage in the project. It is acceptable for the supplier, integrator, and customer to use different validation methodologies, provided that the customer ... 

Furthermore, it is also plain from the definition of validation above that documentary evidence is the lodestar of validation and the tool by which the assurance is derived. In respect of software, the assurance needed will be in the form of documentary evidence, not of the product directly (though this may be included) but, as we have shown, from an examination of the development process that produced it. This strongly implies that the product is inseparable from the process, and the fitness for use of the product can only be secured through the rigorous control of the process that produced it. This ought to come as no surprise, since it is precisely this principle, the essence of the science of statistical process control, that determines the quality of any manufactured or fabricated product. In other words, the quality (of fitness for use) of an item is entirely determined by the process that produced it, where quality is defined according to the ISO 8402 [3] ... 

The quality plan, on the other hand, concentrates on defining the documentary evidence that must materialize at given stages in the project that will prove that the product under development is acquiring the necessary quality characteristics that will fit it for its intended purpose. Examples of such quality controls might be as follows ... 

The results of the study showed that most of the environmental factors measured at the storages of semi-active record of the Ministry of Manpower and the Ministry of Municipalities and Water Resources were not within the stipulated values defined in international standards. The indoor air quality of the two buildings was not suitable for protection and preservation of document collections. Therefore, some preventive measures must be taken to safeguard the documentary assets. The document collection of the two Ministries will be damaged if remedial measures were not taken timely. 

The work of WG 2 on reference materials has been slower, since any such ISO standards must be based on the application of existing reference materials. It should be noted that ISO does not itself develop new reference materials. Also, the documentary standards drafted in subcommittee 2 should in principle define the application of reference materials used by two or more surface analytical techniques. Given that such reference materials tend to be technique specific, the progress of this particular working group has been somewhat limited. 

Through the considerable efforts of the chairman of subcommittee 4, the work program of SC4 is well defined and should ultimately result in the development of a number of documentary standards. The scope of the subcommittee is the standardnation of instrument specification, instrument calibration, instrument operation, data acquisition, and data processing used to determine composition versus depth with surface analytical techniques [3] With these objectives in mind, WGl has defined the following areas which will require the development of ISO standards ... 

In the present state of scientific knowledge, control of the amount of long-chain fatty acids in the human diet is desirable. Suitable— though not rapid, easy or inexpensive—methods of analysis have been developed for the determination of erucic acid in foods. For laboratories which have the capability of capillary GLC, this method would appear to be the best and most rapid, since no sorting test would be necessary. However, as an official reference method, the argentation TLC/GLC procedure is preferred because it requires less specialised apparatus, less experimental art, and is more easily defined in documentary form. When it is further developed, HPLC will also play a part in certain laboratories. 

There are one or two well-tried documentary methods for defining the trip logic that should be considered. 

Establish an effective safety management system/process. Nominate key roles/ responsibilities. Define approval signatories - especially for safety reports. Establish independent verification/audit to reduce chance of undetected error. Establish a workforce-wide commitment to product integrity. Learn from previous mistakes. Initiate a documentary audit trail (identify, log and track all hazards). Airworthiness and safety must be foremost in the minds of the entire organisation. Furthermore, as many legal cases turn on documentation, it is essential that risk assessment activities and choices are documented and that records are kept. ... 

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