Record-Keeping Rule

Often, the IT life cycle planning today is cost-, project-, reaction-, or necessity-based rather than being based on a well-maintained masterplan. This is not necessarily bad. Projects are sponsored by the local department. Hence project teams are closer to where the needs and record keeping rules are defined. However, the project teams need to understand the technology directions of the larger organization to ensure that the proper infrastructure is in place to support the production system. 

U.S. EPA issues Cross-Media Electronic Reporting and Record Keeping Rule (CROMERRR)... 

Q. Are cases of workplace violence considered work-related under the new record-keeping rule ... 

A. The OSHA Bloodborne Pathogens standard states The requirement to establish and maintain a sharps injury log shall apply to any employer who is required to maintain a log of occupational injuries and illnesses irnder 29 CFR 1904. Therefore, if an employer is exempted from the OSHA record-keeping rule, the employer does not have to... 

Record keeping rule revised to improve the system that employers use to track and record workplace injuries and illnesses. 

Physical examinations, employee training and educational programs, medical protection, and record keeping, among others, are required. The regional OSHA office should be consulted for the latest rules and regulations. 

Rules for the welded fabrication of pressure vessels cover welding processes, manufacturer s record keeping on welding procedures, welder qualification, cleaning, fit-up alignment tolerances, and repair of weld defects. Procedures for postweld heat treatment are detailed. Checking the procedures and welders and radiographic and ultrasonic examination of welded joints are covered. 

Quality Control Records. Accurate quality control records are of utmost importance and may be required by law, as in the pharmaceutical industry. A few years ago, mandatory Good Manufacturing Practices were proposed for the cosmetic industry. Although the proposal was later dropped, many manufacturers go by the rules worked out at that time for laboratory testing and record keeping. The food industry also requires extensive testing and record keeping. 

A system of record keeping must be used which eliminates any risk of confusing the samples. As a rule, samples should be recorded immediately after their arrival and, especially in the case of nonfrozen field samples, prior to preparation for analysis. A record should also be kept of the condition of the samples upon arrival at the receiving laboratory and of any packaging or labeling defects. 

Some fairly common mistakes made in managing electronic SOPs, protocols, and changes to them are listed below. If these can be avoided, the resulting computer system should meet the requirements of the US, Organization for Economic Cooperation and Development (OECD), and Ministry of Health, Labor, and Welfare (MHLW) GLP standards as well as the FDA s Rule on Electronic Record Keeping Electronic Signatures. ... 

Final rule issued 44FR33525. Proposed rule for record keeping reporting of Asbestos issued 44FR8200. Not finalized. 

All predicate rule requirements will be enforced. This includes record and record-keeping requirements. 

FDA inspections are conducted for many reasons and the extent of compliance of computer systems with Part 11 may be evaluated during any of these inspections. If applicable, a field investigator will review electronic records in order to evaluate their level of compliance with the predicate rule. At the same time, the investigator may check adequacy of record keeping arrangements for compliance with Part 11. 

FDA asserts that the benefits of electronic record keeping in reduced review time and related business costs, such as space and rapid information access, will offset the costs of compliance with the rule. (Preamble Comment XVI.C.l, p. 13463.) As industry and regulators enter the brave new paperless world, this remains to be verified. 

The Poisons Rules are the detailed legislation of the Poisons Act and outline the rules regarding transport and containers, record-keeping and... 

In contrast to the majority of inventors, pharmaceutical companies anticipate the prerequisites of patent application before discovery. In fact, the strategic plan in drug development includes the details of a successful patent assignment. Application requirements are well defined and known. The rules of record keeping and legal verification in the notebook format by the discovery chemist are well documented. Extensive synthesis of a series of analogues... 

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