Association records

Equipment inspection, maintenance, and repair records can be recorded in a logbook especially designed for that purpose. For equipment that is moved from laboratory to laboratory, the logbook should accompany the equipment when it is moved. Documentation of calibrating or standardizing operations, on the other hand, may be more efficiently recorded with the associated records of the data acquisition activities. 

As life-cycle qualification activities move to the in situ operating environment a methodical approach for the site calibration of control and monitoring instrumentation is needed to provide suitable calibration and any associated records for the loop instrumentation and regulating devices on critical parameter duty. 

FDA regulations require that domestic or foreign manufacturers of regulated products intended for commercial distribution in the United States, establish and follow controls as part of a quality assurance (QA) program. These controls help to ensure that regulated products are safe and effective. The QA controls and associated records required by the FDA are contained in the applicable predicate regulations. 

Security is a key component for maintaining the trustworthiness of a computer system and associated records. Security is an ongoing element to consider, subject to continuous improvement. The security measurements that are implemented on a computer system may be obsolete after several years. 

Study Audit A comparison of raw data and associated records with the interim or final report in order to determine whether the raw data have been accurately reported, to determine whether testing was carried out in accordance with the study plan and Standard Operating Procedures, to obtain additional information not provided in the report, and to establish whether practices were employed in the development of data that would impair their validity. 

FIGURE 2.4 Flow diagram of a single-channel segmented flow analyser and the associated recorder tracing. S/C — sample/carrier wash stream Air = air R = reagent R( = coiled reactor DB — de-bubbler D = detector arrows = sites where pumping is applied. 

Standard operating procedures and associated records of actions taken or, where appropriate, condusions reached should be available for... 

A file of all complaints, other than those known to have no bearing on product quality, together with associated records, should be maintained in accordance with Clauses 834-835. 

All relevant GMP documents (such as associated records of actions taken or conclusions reached) and SOPs are approved, signed and dated by authorized persons. Documents are not altered without authorization. Any alteration made to a document is signed and dated the alteration permits the reading of the original information. Where appropriate, the reason for the change is recorded. 

Where appropriate, there should be written procedures and the associated records of actions taken or conclusions reached for ... 

A review of a representative number of batches, whether approved or rejected, and their associated records and... 

Such a momentous event should have lit up the pharmaceutical world, offering us the opportunity to increase the efficiencies of our development and manufacturing processes and the associated recording activities. At the same time, it offered the prospect of exchanging the mountain of paper, which has been associated with such activities, for much more compact and easily manageable electronic files. 

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 ... 

A.31. Transport arrangements for radioactive material on the site should be examined. Receipt and dispatch arrangements should be inspected and attention should be paid to the integrity of packages, residual levels of contamination and associated records. 

An electrode pair and their two wires are called a bipolar lead. A unipolar/monopolar lead is with one PU and an indifferent electrode or a wire from Wilson s terminal. A lead may be defined physically as two signal wires with an associated recording electrode system. 

The deflectograph is a two-axle truck carrying a beam assembly and an associated recording system between its axles. Deflection measurements are based on the same principle as in Benkelman beam measurements. The deflectograph provides a more rapid method of measuring pavement deflection than the Benkelman beam since setting arrangements are much faster. 

Preventive maintenance program for regulated vehicles, including associated records,... 

A6.1.1 This practice is for the calibration of temperature sensors and vacuum sensors and their associated recording instruments. 

TABLE 3.34 Determination of the Quantum-SAR, seeEq. (3.131) with Eqs. (3.127) and (3.128), Associate With Certain Couple of Molecules Involved in Activating Specific Structural Quantum Indices (Or Their Combinations) Driving Spectral Paths of Table 3.32, By Employing Minimum Residue Recipe Throughout Table 3.33 for Each Considered Endpoint, As Well As the Associate Recorded Bioactivity Differences of... 

Elimination of equipment maintenance and calibration in a biopharmaceutical environment, these costs and associated records can be substantial. 

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