Copying Records

For those records that remain subject to Part 11, enforcement discretion will be exercised with regard to Part 11 requirements for validation, audit trails, record retention, and record copying in the manner described in the guidance and with regard to all Part 11 requirements for systems that were operational before the effective date of Part 11 (also known as legacy systems). 

The intelligent use of clerical and stenographic help saves much searching time. Nontechnical personnel can make author indexes, keep search records, copy marked lists of references from journals for future abstracting, and check bibliographic references against files to prevent duplication. 

Facsimile combines copying with data transmission to produce an image of a subject copy at another location, either nearby or distant. Although the Latin phrase/acsimi/e means to make similar, since 1815 the compressed phrase facsimile has been taken to mean exact copy of a transmission (Quinn, 1989). The image of the subject copy is referred to as a facsimile, or record, copy. Often the abbreviated reference fax is used in place of the longer term facsimile. 

Facsimile The process of making an exact copy of a document through scanning of the subject copy, electronic transmission of the resultant signals modulated by the subject copy, and making a record copy at a remote location. 

Pixel A picture element of a subject or record copy that is represented in shades of gray. 

Record copy The copy of the document made at the receiving end of a facsimile system. 

A model permit system is shown in Table 7.1, containing a suite of permits comprising a general all-purpose format and special applications. The table shows the sequence of actions involved in a permit-to-work system. Where there is expected to be significant use of any or all the permits, it is recommended that a self-carbon pad of each is printed, in order to allow easy sequential numbering and filing of record copies. 

Site management must ensure that building and other controlled waste is placed in suitable containers, so that transfer notes can be completed accurately as to their contents. Monitor the disposal of waste into containers/skips to ensure that unauthorised disposal is prevented. Contact the local authority s waste disposal officer when in doubt. Waste material must be passed only to registered carriers, completing transfer notes before its removal from site and keeping record copies on site. 

The selection and sequence of tubes to be inspected are known at the start of a measurement campaign. After a tube has been measured, the reference is transmitted to the pre-fetching module. This latest can, through an anticipation window, copies a certain number of records on the hard disk. 

The Record of Invention. The second phase of developing a record of the invention is to condense the record into a summary form which serves several purposes. Specifically, the record of invention estabUshes a date of invention through attached copies of notebook records, spectra, and the like which all prove that the invention has in fact been conceived and reduced to practice in some form having practical utihty. 

Carbonless Copy Paper. In carbonless copy paper, also referred to as pressure-sensitive record sheet, an acid-sensitive dye precursor, such as crystal violet lactone or /V-hen2oy11eucomethy1ene blue, is microencapsulated with a high boiling solvent or oil within a cross-linked gelatin (76,83,84) or in synthetic mononuclear microcapsules. Microcapsules that have a starch binder are coated onto the back of the top sheet. This is referred to as a coated-back (CB) sheet. The sheet intended to receive the image is treated on the front (coated-front (CF)) with an acid. When the top sheet is mechanically impacted, the dye capsules mpture and the dye solution is transferred to the receiving sheet where the acid developer activates the dye. 

Ai- 4-(bis[4-(phenylamino)phenyl]methylene)-2,5-cyclohexadien-l-ykdene -3-methyl-ben2eneaminesulfate [57877-94-8] (20) have been claimed as positive CCAs (65). The absorption spectra of the triaryknethane dyes can be extended into the near-infrared region. The use of triaryknethane dyes as infrared absorbers for optical information recording media (66) and as infrared color formers in carbonless copy paper has been claimed. 

The different detergents are an attempt to copy the typical detergent composition commercially available in the U.S. and European markets. The more severe tests in the C06 series are designed to approximate the effect expected from five repeated launderings. In view of the variety of conditions associated with this test it is vital to ensure good communication and data recording in operating the test. 

You must keep a copy of each report. In addition, you must keep the supporting materials used to develop the Information contained in the report. These records must be kept at the facility for a period of three years from the date of the submission and must be readily available for Inspection by EPA. 

Contractor records at Site H indicated that medical tests and procedures included annual examinations that addressed site-specific hazards and were provided with the frequency required by the standard. Records at Site K showed that employees of both contractors had received recent comprehensive medical examinations, and copies of the physician s written opinion were maintained for each employee. These... 

Do the SAHP and site records indicate that the employer obtains and furnishes to the employee a copy of a written opinion from the attending physician that contains the following [OSHA Reference, 120(b)(4)(ii)(D)]... 

If Modify is chosen from the menu, a drop-down menu with the available data types appears Family, Event " ees, Systems, End States, Basic Events, Attributes, Analysis Types, Gates, Hi rams, P Ls, Change Sets, and Flag Sets. After selecting an option, a dialog containing a li f of all records for the selected data type appears. The functions Add, Copy, Modify, and C be selected from another pop-up menu. 

Copy - cop ting record to create a new record in the database. 

Throughout the standard, various clauses reference the clause on quality records. To avoid repetition, the common requirements for quality records are assembled under one heading. The requirements, however, are not limited to those clauses in which this requirement is referenced as many other clauses refer to records. However, as all clauses will generate some documentary evidence it should not be assumed that all such documents are quality records. The requirements, however, apply only to original records and not to any copies other than those taken for security reasons or copies of subcontractor records. There are several types of document used in a quality system and only some are classified as quality records. As quality records are documents it might be assumed that the requirements of clause 4.5 on document and data control apply to quality records. As clause 4.16 is not cross referenced in clause 4.5 (except for clause 4.5.2.2), there is clearly no requirement for you to apply the requirements for document control to quality records. (See also Part 2 Chapter 5.) Figure 5.2 illustrates the difference between quality records and documents. 

It is advisable to identify all your quality records within your procedures. This will avoid arguments on what is or is not a quality record, because once you have chosen to identify a record as a quality record you have invoked all the requirements that are addressed in this chapter. Any document which describes the achieved features and characteristics of a product or service are quality records. Those records which will demonstrate that work has been planned, organized, resourced, monitored, verified, and corrected when found deficient are also quality records. The note following the requirement acknowledges that quality records can be in hard copy or held on a computer disk or magnetic tape. Should both forms be held, you will need to declare which are the masters and provide the appropriate security to prevent inadvertent loss or damage (see below). 

This requirement supplements that for records to be readily retrievable but in addition implies a further requirement for security of records. After addressing the filing and storage requirements, you need to ensure that the records are accessible to those who will need to use them. This applies not only to current records but to those in the archive and any insurance copies you may have stored away. A balance has to be attained... 

It is always risky to keep only one copy of a document. If computer generated, you can easily make another copy provided you always save it, but if manually generated, its loss can be very costly. It is therefore prudent to produce additional copies of critical records as an insurance against inadvertent loss. These insurance copies should be stored in a remote location under the control of the same authority that controls the original records. Insurance copies of computer disks should also be kept in case of problems with the hard disk or file server, if you use one. 

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