Quality records indexing

Are quality records collected, indexed, accessed, filed, stored, maintained, and dispositioned in accordance with documented procedures ... 

The standard requires the supplier to establish and maintain procedures for the indexing of quality records. 

You may only need one procedure that covers all the requirements but this is not always practical. The provisions you make for specific quality records should be included in the procedures for controlling the activity being recorded. For example, provisions for inspection records should be included in the inspection procedures, provisions for design review records should be included in the design review procedure. Within such procedures you should provide the forms (or content requirements for the records), the identification, collection/submission provisions, the indexing and filing provisions. It may be more practical to cover the storage, disposal, and retention provisions in separate procedures because they may not be type-dependent. Where each department retains its own records, these provisions may vary and therefore warrant separate procedures. 

The procedure is established and maintained for identification, collection, indexing, filing, storage, maintenance, and disposition of quality records. 

Photoelectric-Colorimetric Method. Although the recording spectrophotometer is, for food work at least, a research tool, another instrument, the Hunter multipurpose reflectometer (4), is available and may prove to be applicable to industrial quality control. (The newer Hunter color and color difference meter which eliminates considerable calculation will probably be even more directly applicable. Another make of reflection meter has recently been made available commercially that uses filters similar to those developed by Hunter and can be used to obtain a similar type of data.) This instrument is not a spectrophotometer, for it does not primarily measure the variation of any property of samples with respect to wave length, but certain colorimetric indexes are calculated from separate readings with amber, blue, and green filters, designated A, B, and G, respectively. The most useful indexes in food color work obtainable with this type of instrument have been G, which gives a... 

Patients with short-term or chronic insomnia should be evaluated after 1 week of therapy to assess for drug effectiveness, adverse events, and compliance with nonpharmacologic recommendations. Patients should be instructed to maintain a sleep diary, including a daily recording of awakenings, medications taken, naps, and an index of sleep quality. 

A short guard column containing the same stationary phase as the analytical column is placed before the analytical column to protect it from contamination with particles or irreversibly adsorbed solutes. A high-quality pump provides smooth solvent flow. The injection valve allows rapid, precise sample introduction. The column is best housed in an oven to maintain a reproducible temperature. Column efficiency increases at elevated temperature because the rate of mass transfer between phases is increased. Mass spectro-metric detection provides quantitative and qualitative information for each substance eluted from the column. Ultraviolet detection is most common and it can provide qualitative information if a photodiode array is used to record a full spectrum of each analyte. Refractive index detection has universal response but is not very sensitive. Evaporative light scattering responds to the mass of each... 

Examples of product quality GxP data include study data (e.g., stability trial data, clinical trial data, patient and animal records/results), regulatory submissions (e.g., stability data, development summary reports), analytical production data (e.g., analytical methods, quality reference data), and compliance management (e.g., indexes to archived documents/records). 

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