Records and reports

Appropriate arrangements should be made for the orderly collection of records and the production of reports on MS I activities. Records and reports are necessary to provide objective evidence that the MS I programme is being implemented fully 

The procedures for MS l should be designed to facilitate the generation of records. In general, records should identify those MS I personnel and operating personnel who were concerned with the work, and should include certification by supervisors or inspectors as appropriate. 

The MS I group should be required by an administrative procedure to select records which provide a meaningful history of the plant and to retain them throughout the plant s lifetime. Other records that have only a transitory value (such as records on individual components that have been replaced) should be retained either until they cease to serve the purpose for which they were intended or until they are superseded by subsequent records. An important factor that should be considered in selecting records to be retained is their usefulness in assembling reliability data. More information on the retention of records necessary for quality assurance purposes can be found in Ref. [2], in particular in Safety Guide Q3 on Document Control and Records. 

More information on the specific types of records and documentation relevant to surveillance and in-service inspection is given in paras 9.45-9.46 and 10.45-10.47. 

This section shall provide information on the facility system for controlling operational records, data and reports that are important for safety. These records may comprise data on  

This section shall give the minimum time interval for which records are to be stored in accordance with the QA programme for the facility operation (see Chapter A. 18, Quality Assurance). 

Administrative procedures consistent with the quality assurance programme shall be developed for the generation, collection, retention and archiving of records and reports. Information entries in logbooks, checklists and other appropriate records shall be properly dated and signed. 

Records of non-compliance and the measures taken to return the research reactor to compliance shall be prepared and retained and shall be made available to the regulatory body. The operating organization shall specify the records to be retained and their retention periods. 

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All testing to support notification must be performed by methods specified in Annex V to Directive 79/831/EEC and in accordance with the principles of good laboratory practice (GLP). GLP is concerned with the organizational processes and conditions under which laboratory studies are planned, performed, monitored, recorded and reported. 

Is lost, damaged, or unsuitable customer supplied product recorded and reported to the customer ... 

To provide staff with the necessary organizational freedom you will need one or more problem-reporting procedures and some policies that give staff the freedom to identify, record, and report problems relating to the product, process, and quality system. 

The standard requires that any such product that is lost, damaged, or is otherwise unsuitable for use be recorded and reported to the customer and again advises the supplier that verification bp the supplier does not absolve the customer of the responsibility to provide acceptable product. 

It is important for the nurse to note the presence of suicidal thoughts. The nurse accurately documents in the patient s record and reports to the primary health care provider any statements concerning suicide and the ability of the patient to carry out any suicide intentions. The nurse performs a physical assessment, which includes obtaining blood pressure measurements on both arms with the patient in a sitting position, pulse, respiratory rate, and weight. 

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. 

Clinical trials must be conducted in accordance with the principles of Good Clinical Practice (GCP). GCP is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Its purpose is twofold ... 

Procedures for eliciting reports of and for recording and reporting adverse event and intercurrent illnesses. 

The sponsor is responsible for implementing and maintaining quality assurance and quality control systems with written SOPs [standard operating procedures] to ensure that trials are conducted and data are generated, documented (recorded), and reported in compliance with the protocol, GCP, and the applicable regulatory requirement(s). ... 

Packaging and labeling control Holding and distribution Laboratory control Records and reports... 

Subpart E Control of Components and Drug Product Containers and Closures Subpart F Production and Process Controls Subpart G Packaging and Labeling Control Subpart H Holding and Distribution Subpart I Laboratory Controls Subpart J Records and Reports Subpart K Returned and Salvaged Drug Products... 

National Primary Drinking Water Regulations Implementation Records and reports kept by States Yes 40 CFR 142.14-142.15 EPA 1976c... 

Finally, another obstacle is that some clients will not seek help out of fear that others will discover that they have drug problems and use that information against them. One solution is to educate the client about federal confidentiality laws that protect against disclosure while in treatment, or state laws that protect client confidentiality in therapy. Flowever, you also should be very honest that there are ways in which confidentiality can be suspended, or when outside institutions can access personal health information. For example, make sure to explain that state confidentiality laws can and will be suspended if the client expresses thoughts about harming him- or herself or others, and in some states, if he or she damages property. Additionally, if a client is mandated to services, he or she should be told that those officials who mandated the treatment may have access to treatment records and reports. Finally, tell clients that insurance carriers and their representatives also may have the right to access that information. Clients should be made aware that there are a number of protections in place to protect them, but also told frankly that some of the protections have limits. 

Records and reports require that any procedures or other records required to be maintained in compliance with these Good Compounding Practices shall be retained for the same period of time as each State requires for the retention of prescription files. 

CFR 1904, Recording and Reporting Occupational Injuries and Illnesses. Effective January 1, 2002 The US OSHA website for recordkeeping revisions is http //www.osha.gov/recordkeeping/index.html... 

GLP is a managerial concept covering the organizational process and the conditions under which laboratory studies are planned, performed, monitored, recorded, and reported. Its principles must be followed by test facilities carrying out studies to be submitted to national authorities for the purposes of assessment of chemicals and other uses relating to the protection of man and the environment. 

All clinical trials should be subjected to QA, either by an in-house department or by external consultants. QA is defined as all those planned and systematic actions that are established to ensure that the trial is performed and the data generated, documented (recorded), and reported in compliance with GCP and the applicable regulatory requirements(s) (ICH GCP 1 -46). Those persons... 

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