Documentation maintaining

Thereafter, the primary functions of the study QA specialist fell into two main headings. First, GLP compliance during the collection and documentation of commodity samples had to be assured. This was done via observation of several collections for different shops (collection incidents) at various geographic locations. In these audits, the study QA specialist examined specific items, such as (1) did the shopper follow the written instructions, (2) were the correct types and numbers of samples collected, (3) was the documentation maintained as required, (4) were the samples labeled and packaged correctly, and (5) were the samples delivered to the shipper as required Findings were communicated to study management and used as appropriate in subsequent shops. 

Procedures shall be established to describe how changes in documents maintained in computerized systems are made and controlled... 

Documentation maintained in both hardware and software form as appropriate... 

Lack of procedures to ensure records are included with vahdation documentation, maintained, and updated when changes are made. P A Warning Letter, 2001]... 

Collecting data that are accurate, honest, reliable and credible is one of the most important objectives of conducting clinical research. It is difficult to achieve. However, in general, data in CRFs are not credible to the regulators unless they can be supported by the real documents (i.e. the source documents maintained at the study site for the clinical care of the study subject). 

Refineries Refineries lobbied that the emissions from the catalytic crackers are needed for the production of low-sulphur gasoline and should therefore be considered as process emissions. This in turn meant that they should be subject to allocation based on projected emissions. They submitted technical documents, maintained a low profile and received the allocation they suggested. 

Documentation Maintain complete records Method is documented in an SOP Validation documents are GLP compliant Amend master validation report as needed Method is documented in an SOP Validation documents are GLP compliant Amend master validation report as needed... 

Maintain power Maintain Manage Maintain Document Maintain Maintain... 

Clinical engineering maintains non-life-support equipment according to a maintenance plan. This maintenance is documented. Maintain inspection and service records in the AIMS database. Use these records to determine inspection intervals, based on an analysis of the history of failures during scheduled inspections. Adjust the inspection schedule to meet any requirements for preventive maintenance. 

All fire protection equipment be inspected no less than once monthly with documentation maintained for each piece of equipment inspected. 

Documentation of annual/comprehensive inspection. The following information must be documented, maintained, and retained for a minimum of 12 months, by the employer that conducts the inspection ... 

Some records relating to individual licensed atomic-power facilities are available to researchers. Each facility has its own official documentation, maintained in a docket file at the Nuclear Regulatory Commission s Washington, D.C. headquarters. A duplicate docket is kept in the Commission s main public-document room. The files contain documents developed by the utility, vendor, and agency staff. They include items such as applications, safety reports, evaluations, and construction permits and operating licenses with amendments. Each docket is a documentary history in itself of a particular reactor facility and provides insight into the complicated task of licensing a plant. 

It is essential that as-built architectural/constmction drawings are given to maintenance at the completion of every job, together with all other job documents, such as equipment information, operating instmctions, test data, supply information, etc. These documents are needed to operate and maintain the faciHty effectively. At the completion of any project, there should be an official acceptance of documentation by the maintenance/operation department. No job is complete without this formal acceptance and sign off. 

National Standards Association, Inc. 5161 River Road Bethesda, Md. 20816 Maintains a standards and specifications database for online searching of government and industry standards, specifications, and related documents (see Databases). 

Asthma is an extremely complex condition characterized by variable and reversible airways obstmction combiaed with nonspecific bronchial hypersensitivity (1 3). The cause of asthma, which is not always readily diagnosed (4), remains unknown. Days, if not weeks, ate needed to document the spontaneous reversal of the airways obstmction ia some patients. Asthmatics experience both an immediate hypersensitivity response and a delayed late-phase reaction, each mediated by a different pathway. Chronic asthma has come to be viewed as an inflammatory disease (5). The late-phase reaction plays a key role ia iaduciag and maintaining the inflammatory state which ia turn is thought to iaduce the bronchial hyperresponsiveness (6). The airways obstmction results from both contraction of airways smooth muscle and excessive bronchial edema. Edema, a characteristic of inflammatory states, is accompanied, ia this case, by the formation of a viscous mucus which can completely block the small airways. 

On a still larger scale, the making of full-size Polacolor repHcas of works of art provides accurate images for display and for professional study and documentation (see Fine art examination and conservation). Because these do not involve photographic reduction and enlargement, the 1 1 repHcas maintain the fine detail and dimensional relationships of the original subjects. 

Once a toller has been selected and any required preliminary confidentiality protection is in place, the client typically shares more detailed information. The toller can then make an informed decision about the economic, technical, and safety aspects involved in bidding the work. If the two parties decide the project will be mutually beneficial, agreements and obligations are negotiated and then formalized in a written contract. Both parties—the client and the toller—have roles in fulfilling the contract and in carrying out their responsibilities to the workers and the public. The purpose of the written contract is to clarify and document those roles and responsibilities to effectively execute, maintain and eventually terminate the project. 

If a toll process falls under the U.S. PSM or RMP regulations, it is a requirement to document the identity of the employee, the date of the training, and the means used to verify that the employee understood the training. Even when not required by regulations, this documentation will enable the toller to demonstrate a commitment to maintaining competent operating personnel. 

Like decontamination, directions for proper waste disposal should be indicated in the initial technology package. In some cases, the client company should be very involved in how certain wastes are handled and disposed of, and may even maintain control over this part of the toll. Both parties have vested interest in assuring waste disposal is properly completed and adequately documented prior to termination of contract. 

Most tolls involve the transfer of proprietary information from one party to the other, typically from the client company to the toller. Each party should have maintained a log of transferred documents or software code to make the return of proprietary documents a simple matter. An initial list of the documents should have been referenced in the contract or as part of the technology package. Keeping records of additional documents transferred during the course of the toll will help eliminate confusion at the end of the project. The toller may need to retain documents appropriate for their process safety system needs. 

Process hazard analyses, waste manifests, bills of lading, employee exposure data and other records may need to be maintained beyond the life of the toll. It is typically the toller s responsibility to maintain records of activities that occurred at their site although the client company may choose to keep duplicate records when deemed appropriate. Some of these documents may be proprietary and should be maintained as such. 

Certificate of Insurance A document verifying that a company maintains insurance at a specific coverage level. 

Control Technique Guidelines (CTG) EPA documents designed to assist state and local pollution authorities to achieve and maintain air quality standards for certain sources (e.g., organic emissions from solvent metal cleaning known as degreasing) through reasonably available control technologies (RACT). 

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