The importance of documentation

The above facts underscore the critical need for documentation of chemometric model building. With sufficient documentation in place, the user is able to continue working on model development on an interrupted project in a time-efficient manner, and without duplicating prior effort. Documentation on the final model(s) that is currently being used on-line can also serve to provide necessary information for satisfying regulatory agencies such as ISO and the FDA, provided that they contain the required information about the models. 

The above discussion leads to the following question Exactly what information about a chemometric model should be documented For cases where documentation is required by law, I refer the reader to the appropriate publications.83,84 For those who would like to document to improve their efficiency during the exploratory modeling and final model building steps, I suggest the following as a minimum  

Chemometrics software vendors have come a long way in facilitating good documentation of models. 

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The importance of documenting internal processes in the form of SOPs has already been mentioned. Any activity forming part of the development plan is a process. Each SOP should be looked on as a dynamic document and opportunities for improving each process should be sought continually. For example, the time that elapses between the last patient completing a clinical trial and production of the statistical report is an activity very much on the critical path. 

Good documentation should capture the entire validation activity. If there is no documentation, on what will you record your validations Was the protocol approved Where are the necessary procedures What happened in validation event 2 How many samples were pulled in validation event 1 Each of these questions supports the importance of documentation. 

The importance of documentation as a tool to assist in preserving digital material is universally agreed upon. In addition to the metadata necessary for resource discovery, other sorts of metadata, including preservation metadata, describing the software, hardware, and management requirements of the digital material, will provide essential information for preservation. 

In the preceding sections, the importance of documenting procedures and passing on quality information to the end user has been repeatedly stressed. Two areas not covered by the previous discussions are management responsibilities and... 

As the opportunities to become more patient-focused increase and market pressures exert increased accountability for pharmacists actions, the importance of documenting pharmacists professional activities related to patient care will become paramount in the years to come. Processes to document the clinical activities and therapeutic interventions of pharmacists have been described extensively in the pharmacy literature, yet universal adoption of documentation throughout pharmacy practice remains inconsistent, incomplete, and misunderstood. 

Since Sleeter s review, several cases have been tried using chemical fingerprinting to determine the source of an oil spill. The three cases tried in 1977 emphasized the importance of documentation, beginning with the taking of the sample (long before the chemist becomes involved) and requiring an unbroken chain of custody until the sample is disposed of. 

The importance of documentation is obvious in the pharmaceutical industry, as there are both regulatory reasons and good business practice requirements for documentation in almost all areas of the pharmaceutical business. 

One of the most important practical aspects of infrared spectroscopy is that it may be applied to almost any type of sample in any physical state, form, or modification. In this section, sampling will be discussed in terms of physical state and/or physical nature of the sample. One point that will be emphasized throughout is the importance of documentation of all experimental procedures, sampling methods and conditions, and any abnormalities observed during the sample preparation procedure. 

In defending any allegation of negligence, the burden will be on the mamrfactirrer or designer to show that they took all reasonable care to avoid such an eventuality and this is frequently done by showing that all relevant standards and codes of practice have been adhered to, hence the importance of documents snch as those referred to in Sections 10.1 and 10.2. Snch an approach has gained judicial approval, as for instance, in the case of Sevan... 

The importance of an accurate and complete record of invention caimot be underestimated. The record of invention should serve as the basic document for estabUshing the date of conception and reduction to practice of the invention. The U.S. PTO issues patents to those who are first to invent. In a contest over inventorship, any available record of invention is submitted to the U.S. PTO to estabUsh proof of an inventor s rights. As of January 1, 1996, any inventor from a country belonging to the World Trade Organization may use such evidence before the U.S. PTO. Previously, this type of proof could be rehed upon only if the activity, documented in the notebook, record, etc, was undertaken in the United States. Similarly, activity undertaken after December 8, 1993 in Mexico or Canada may also be rehed upon to prove inventorship. 

The reversible oxidation of L-ascorbic acid to dehydro-L-ascorbic acid is the basis for its known physiological activities, stabiUties, and technical apphcations (2). The importance of vitamin C in nutrition and the maintenance of good health is well documented. Over 22,000 references relating only to L-ascorbic acid have appeared since 1966. 

These few remarks should suffice to demonstrate the importance of the precise knowledge of the various layer materials and the precise documentation of their use. Such differences should also be taken into account when choosing the stationary phase so that the impression is not later produced that phase A is better or worse than phase B. 

Document and data control is one of the most important aspects of the quality system. Although not the only aspect of the quality system, documentation is the foundation stone. The requirements for document and data control can be confusing because the standard doesn t specify what a document is and whether a record is a document or whether data are documents. As data is information and documents are recorded information perhaps this clause should have been headed Information control. There is often confusion also between quality system documents and quality documents and between technical documents and quality documents. There is no doubt that all documents, data, and records should be controlled but the types of control will vary depending on the type of document. 

It seems unlikely that feedbacks due to species replacement have begun since the beginning of the Mauna Loa record because compositional changes due to climate change will take decades and have not yet been documented on a wide scale. However, this fact increases the importance of such feedbacks to future trends in atmospheric CO2 when these feedbacks become important it is highly unlikely that positive and negative feedbacks will exactly cancel each other and more likely that one or the other will prevail and cause deviations from current trends in atmospheric CO2. 

This information is to be submitted to the authorized ECHA for the purpose of substance registrations (details see above in clause 3.4). The essential information should be recorded in the factsheet (SDS) of each chemical including exposure scenarios in case they are substantial. This article describes the importance of the waste stage in the drafting of exposure scenarios. The waste phase is to be included in the calculation of exposure. As part of the implementation of REACH, guidance documents were developed with detailed recommendations which describe how this is to be done. Important aspects of this procedure are explained above. 

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