Traditional Documentation Control

The central requirement of documentation control is a filing system, which has to provide the following functions. 

The amount of work needed to do this properly is too often underestimated, with consequential overload and inefficiency. The document control system is the nervous system of the project, overseeing the transmission of information. Both order and speed are essential. This means that the resources available for this operation must exceed the average need, or there will be delays during peak loads. 

It usually pays handsome dividends to employ at least one technically 

The nature of the work is repetitive and easily codified in a procedure. The number of documents to be processed is predictable, and the timing is more or less predictable. The work can and must be planned, and adequate resources made available, on pain of losing control of the project when, for instance, it takes a week to circulate a batch of vendor drawings because they must first be renumbered in the project system, but the document controller is overloaded. And the delay may only be recognized when the time has been irretrievably lost. 

Document indexes are usually based on classification by t)q)e of document, serial number, date, and revision. They can also be classified by subject, size, source, and sometimes by destination. There are also very many cross-references which can be useful purchase order number, responsible project co-ordinator, etc. There are many possible schemes for numbering systems. 

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A document is a piece of recorded in formation of any type (hard copy, electronic, physical model). This subject is further developed in Chapter 20, Traditional Documentation Control. 

Documentation controls apply to system development and maintenance as well as to use. Development practices and procedures need to documented according to a Quality Management System (QMS) [4] and controlled in the same way as other GxP documents. Of particular importance is the establishment of an audit trail for documentation and management of change control and the associated records. The FDA needs to be able to establish unequivocally which version of software was running on what equipment, at which time, when every record was created. One of the effects of this rule is clearly to bring the IT Department, traditionally seen as being on the periphery of GxP, firmly within the fold ... 

The Savannah River Site (SRS) reactor operation has traditionally been controlled by the instructions in detailed operating procedures. In 1975, safety requirements were established in the Technical Specifications and more specific controls were established in the Technical Standards to identify overall plant safety requirements, which were previously determined by supervisors. The supervisor was responsible for understanding and interpreting the technical bases supporting these documents, which were described in other safety documents such as technical reports and technical manuals. It was determined that this process was deficient in human factors considerations, that it lacked an integrated approach, and that the validity of some of the technical bases were not well established and documented. 

It is not possible to achieve "adequate control" of the risks of persistent, bioaccumulative chemicals. The fact that traditional risk assessment cannot reasonably be applied to such chemicals, and that a revised PBT (persistent, bioaccumulative, toxic) assessment is necessary, is explicitly recognised in the EU s Technical Guidance Document for risk assessment. Their intrinsic properties mean that there is a high risk of exposure at sometime during the lifecycle of the chemical or the article that contains it. Even small releases, if they are continuous, can result in significant exposures. This is why we see significant and, in some cases, escalating levels of brominated flame retardants, nonylphenols and other persistent chemicals in breast milk, umbilical cord blood and human tissue. 

In general the quality control procedures for products obtained through biotechnology are very similar to those routinely used with traditional pharmaceutical products in areas such as raw material testing, documentation of process control, and aseptic processing. The fundamental difference is in the type of methods used, so as to determine the product s identity, uniformity, and purity. In the quality control of products obtained through recombinant DNA technology, it is necessary to employ validated tests for the final and intermediary products to ensure the elimination of undesirable impurities. 

Dynamic work strategies In this element, work planning documents such as the CSM are written and updated in real-time (e.g., while project crews are still in the field). A unique aspect of dynamic work strategies is a quality control process that adapts in real-time, unlike traditional work strategies, which implement quality control on analytical processes that are far removed from the activities of the field. 

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