Generating Records

All raw data, documentation, and records generated in the design and operation of the automated data collection system must be archived in a manner that is orderly and fa-cihtates retrieval. If stored on the system, such data must be... 

Amounts of Raw Data. The types of paper and/or electronic records generated in this example are shown in Table I. 

The design must ensure that records generated by computer systems conform to their specified content. Records covering computer inputs, outputs, and data must be accurate. The computer system should also include built-in checks of the correctness of data that are entered and processed. Manual entry of critical data should be subjected to a confirmation check within the design that may be either manual or automatic. 

If this is required, especially to analyze product, then the data collection and analysis will need to be checked as part of the adeqnate size as some data files can be in the Mb range. The file delete option should not be enabled to protect the electronic records generated. 

Validation of the migration of electronic records generated using MassChrom software on the Macintosh systems to the new Analyst NT environment, as well as data aequisition on some Macintosh platforms with interpretation using Analyst software... 

Records required by the predicate rules have to be maintained throughout the required record retention periods. This also holds true for records generated electronically, but the guidance document from 2003 allows the application of a risk-based approach to... 

Irradiator parameters should be kept constant, monitored and recorded during dose mapping. The records, together with the dosimetry results and all other records generated, should be retained. 

This evidence includes records generated under paragraph C.02012(2). 

Many records generated since this time have confirmed these early observations, namely ... 

This requirement is covered by Section 211.280 - General Requirements, which indicates that all the records generated must be available for inspection at any time. Companies must consider their extended laboratories, especially those that are a part of their outsourcing paradigm. For marketed products, these data must be reviewed annually. 

Records generated by the asset management process are used to bring about continuous improvement in order to increase the effectiveness and efficiency of the EAM strategy. All changes arising from the review must be controlled and documented. 

Much dialogue took place between the industry and the FDA during the development of the rule, and the final result is better and more practical as a result. However, there are significant difficulties with the rule as it stands, particularly with its application to noncompliant electronic records generated with systems that were in place when the rule became law, the so-called "legacy systems" problems. 

Records generated from the FSA should be complete and the conclusions agreed with those responsible for the management of functional safety for the SIS prior to commencement of the next lifecycle phase. 

AutoMonitor is implemented mainly in HyperTalk, in HyperCard 1.2. This means that it is a relatively simple matter for any HyperCard programmer to tailor the interaction record generated, to suit individual experimental requirements. This may involve either trimming down the classes of event recorded or extending the record to include actions where HyperCard itself may have been extended, for example the use of non-standard pop-up menus. 

Tensile creep deformation is characterized by measurement of the relative change in uniaxial length (t) from the initial 118.5-mm grip distance for prolonged periods of time. The continuous pen recorder generates a plot of axial displacement A f versus creep time. 

Master lists of EPCM contractor s documents including drawings, specifications and requisitions, initially as lists of documents to be produced, subsequently recording generation of documents and successive revisions status... 

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