Storage of records

Automated dissolution equipment in most cases must be compliant with the FDA electronic records and electronic signatures regulation (21 CFR Part 11). The requirements of the regulation include use of validated systems, secure storage of records, computer generated audit trails, system and data security via limited access privileges, and the use of electronic signatures. 

Freezer storage of record samples and working samples is good, but could possibly be improved if separate facilities for the Analytical Labs were available. Documentation of storage temperatures is needed. Some provisions should be made. .. to notify the lab when record samples can be discarded. 

This chapter mostly emphasizes materials, procedures, and products for the creation, repair, and storage of records. This aspect is only part of the picture, as records materials are only the media for storage, retrieval, and use of information. Although we are aware of the need for, and of considerable activity in, areas such as buildings, equipment, automation, and archival arrangement and description, these subject areas are left to others who are more competent to address them. Technical standards for library and information science were covered in Library Trends (I), international standards for archives were discussed by Rhoads (2), and the general subject of standards for libraries and archives was developed by Clark (3). 

Requirements for controls are based on definition of closed or open system. Under these definitions there isno direct correlation between, for example, using a publicphone line and an open system. Compliance with closed versus open standards is determined by how access rights to the data or documents are established and controlled by the owner(s) of this information. A system is defined as closed if access to the system containing the records or data is under the control of person(s) responsible for the content of the records or data in the system. A system is defined as open if access to the system is not under the control of the person(s) responsible for the content of the records therein. For example, dial-in retrieval over a public phone is closed where the records being accessed are under the control of the persons responsible for their content, whereas storage of records on a third party system is open because access to the records themselves is under the control of the third party. Sections 11.10 and 11.30 of the Final Rule list, respectively, the control measures required for establishing a closed or open system. 

Sufficient areas for the storage of records, including product information, manufacturers information and inspection reports, should be available. 

The central feature of securing IRB approval is to ensure all human subjects provide informed consent for their participation. Typically, informed consent issues with students and teachers include ensuring the confidentiality of student responses, no coercion to participate in the study, secure storage of records, etc. Minors cannot give informed consent, so any study involving students under the age of 18 (which includes mmiy college freshmen) must secure both parental consent and student assent. Research studies in K-12 settings require this plus approval of the local school board and/or district office. 

The training section ideally should be a formal training needs assessment and storage of records. It could also be used as a central location for the listing of training topics and specific objectives for each section of the chemical hygiene plan. 

Further information relating to the retention and storage of records for SIS can be found in the guidance provided against Recommendation 2. Management of instrumented systems for fuel storage tank installations . 

Pulsed-force mode AFM (PFM-AFM) is a method introduced for fast mapping of local stiffness and adliesion with lower required data storage than recording force-distance curves at each point on the x-y plane [115]. A sinusoidal or triangular modulation is applied between the tip and sample (either via lever or sample piezo) at a lower frequency than that of either the piezo or cantilever resonance frequency. Tip and sample then come... 

An ion beam causes secondary electrons to be ejected from a metal surface. These secondaries can be measured as an electric current directly through a Faraday cup or indirectly after amplification, as with an electron multiplier or a scintillation device. These ion collectors are located at a fixed point in a mass spectrometer, and all ions are focused on that point — hence the name, point ion collector. In all cases, the resultant flow of an electric current is used to drive some form of recorder or is passed to an information storage device (data system). 

The contractors SSAHPs at Sites I and K required that safety and health program inspections be conducted however, these requirements were not effectively implemented at either of these sites. Both Site K contractors required the HSO to conduct daily inspections, and both stated in their written plans that hazards would be immediately corrected. Neither contractor, however, had established hazard abatement procedures to ensure the prompt correction of hazards, and site records for both contractors indicated that hazard abatement activities were either not documented or not completed. For example, the subcontractor s daily safety log contained several notations of safety hazards, including an unstable concrete well and storage of diesel cans near the propane tank however, later log entries and site records did not track the abatement of these hazards. 

The procedures that require the use or preparation of documents should also specify or invoke the procedures for their control. If the controls are unique to the document, they should be specified in the procedure that requires the document. You can produce one or more common procedures which deal with the controls that apply to all documents. Although ISO 9001 does not address all controls under clause 4.5, the provisions of clause 4.16 relating to the identification, access, filing, and storage of quality records are equally appropriate to documents in general and should be applied although it is not mandatory. 

Provide data storage systems which enable rapid retrieval of records by product identification. 

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... 

The standard requires the supplier to establish and maintain documented procedures for the storage of quality records and in addition requires quality records to be stored in facilities that provide a suitable environment to prevent damage or deterioration and to prevent loss. 

The documentation system should include guidelines regarding the access of records by customers and suppliers, change control procedures, the types of records to be collected, and specifications for indexing, filing, storage, maintenance, retrieval, and disposition. 

PYI —Collection of records that normally consist of matching types of fields. Records in a file may be accessed sequentially (the entire file must be read until the needed record is reached) or randomly (the record contains a key field, which determines its physical location in storage). 

Methods are described for determining the extent to which original natural color is preserved in processing and subsequent storage of foods. Color differences may be evaluated indirectly in terms of some physical characteristic of the sample or extracted fraction thereof that is largely responsible for the color characteristics. For evaluation more directly in terms of what the observer actually sees, color differences are measured by reflectance spectrophotometry and photoelectric colorimetry and expressed as differences in psychophysical indexes such as luminous reflectance and chromaticity. The reflectance spectro-photometric method provides time-constant records in research investigation on foods, while photoelectric colorimeters and reflectometers may prove useful in industrial color applications. Psychophysical notation may be converted by standard methods to the colorimetrically more descriptive terms of Munsell hue, value, and chroma. Here color charts are useful for a direct evaluation of results. 

There are no objective tests which will enable one to tell at what point mishandling in storage took place. The packer who fails to keep a record of the quality and condition of his product as it is placed in storage, of the storage conditions, and of product condition as it is loaded for shipment is exposing himself to unnecessary risk. Without such records he may find himself unable to refute unjust or misdirected claims initiated by the buyer. 

Reporting of study results 9.1. General 9.2. Content of the final report 10. Storage and retention of records and materials Subpart J - Records and Reports Sec. 58.185 Reporting of nonclinical laboratory study results. Sec. 58.190 Storage and retrieval of records and data. Sec. 58.195 Retention of records. 

Many laboratories find it practical to keep separate records for these, which means that the sample numbering system for raw materials must be different from that used for finished products. Other laboratories lump everything together for the purpose of record keeping but have separate storage areas for the two types of samples. 

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