Documentation, defined

A distinct difference between examiners citations on granted U.S. patents and those on pubHshed patent appHcations is that the latter can indeed represent direct anticipation. Thus they represent a close subject relationship to the document in question. An important factor in the citations on EPO and PCT appHcations is that they are categorized by the examiner with regard to their relevance documents of particular relevance in themselves, documents of particular relevance in combination with some other document(s), and documents defining the general state of the art but of no particular relevance in themselves. Clearly not aH citations have the same value. 

Three steps are identified (1) defining the process to be analyzed, (2) doing the analysis, and (3) documentation. Defining the process and documenting the results can be performed ry one person, but the PSM rule requires a team for the analysis. 

The standard does not stipulate which method should be used. In very small companies a lack of such documents defining responsibility and authority may not prove detrimental to quality provided people are made aware of their responsibilities and adequately trained. However, if you are going to rely on training, there has to be some written material which is used so that training is carried out to consistent standards. 

Process knowledge and documentation Define P IDs needed Establish management system for future updates... 

The second improvement comes from the potential that computers have, in conjunction with newer processes, to dramatically reduce the cost and time required to monitor data. Most of monitoring involves comparing a source document, defined as the first place a piece of data was recorded, with what was written. Because data are often recorded by first entry in a patient record,... 

This document defines the most commonly used terms relating to polymers containing ionizable or ionic groups and to polymers containing ions. Inorganic materials, such as certain phosphates, silicates, etc., that also may be considered ionic polymers are excluded from the present document. Only those terms that could be defined without ambiguity are considered. Cross-references to terms defined elsewhere within the document are printed in italic type. 

A metrological reference is a document defining (usually) a unit. A rational quantity scale, of quantities that can be compared by ratio and have a zero (e.g., length, mass, amount of substance, but not temperature in degrees Celsius), must have a unit, even if it is 1. 

The guidance specifies the application information that should be provided to the Center for Drug Evaluation and Research (CDER) to ensure continuing product quality and performance chacteristics of the sernisolid topical formulation for specified changes. The guidance does not comment on or otherwise affect compliance/inspection documentation defined by the Office of Compliance in CDER or the Office of Regulatory Affairs at FDA. 

This master plan is used, managed, and enforced throughout the life of a process to help ensure quality. The document defines the validation approach, specifies the responsibilities of each of the validation team members, and is an important part of the overall validation effort at the beginning of a project. 

The technical design specification deliverable for the computer system is a document defining the system in sufficient detail to enable it to be built, and to enable code to be produced for it, including ... 

Other means of evaluating the toxic effects of vapors, and their potential impact on exposed people, can be found in the Emergency Response Planning Guidelines for Air Contaminants (ERPGs), issued by the American Industrial Hygiene Association (1992). The documents define values of exposure to toxic vapors needed to produce specific health effects. Three levels of vapor concentration are defined ... 

An important area of harmonization was defining the key parameters of a replicate, such as duration of monitoring, in passive dosimetry and biological monitoring studies. The OECD guidance document defines a replicate as a measurement of exposure to a worker during one typical workday, which includes all job functions related to pesticide use. 

No formal documents defining the validation requirements for computer systems. Specifications to define the intended software operation were not available. 

The Validation Report for a system must not be approved until all the relevant documents defined within its Validation Plan have been approved. Approval of the Validation Report marks the completion of the validation process. The Validation Report must, therefore, include a clear statement confirming whether or not all computer systems are validated and fit for purpose. 

The computer system lacked documentation defining database, operating system, location of files, and security access to database. [FDA Warning Letter, 2001]... 

The CCT is the scientific tool for demonstrating causality. Two essential elements characterize the CCT (a) it contains a control group and an experimental group, and (b) with the exception of treatment, all other conditions and procedures to which the subjects are exposed during the trial are constant. These two characteristics of the CCT enable the researcher to establish a causal relationship between treatment and the outcome of the trial. The tool for standardizing the trial is the study protocol, the document defining the subjects eligible for inclusion in the study, the study procedures and schedules. 

The scope of the document defines the specific product and method combination being validated. It also states the department responsible for running the assays and the facility (or facilities) where the method is being validated. If more than one facility is involved then reproducibihty of the method between laboratories needs to be validated.]... 

A lot of effort is invested at the beginning of the project in defining the scope of work and expectations for transfer completion. This is best covered in a document defining the scope and goal of the method transfer, the regulatory standard to be applied (e.g., following GLP or not), experimental outline, acceptance criteria for assay performance, and transfer or development summary or report. It is useful to spend some time on such a protocol to reduce the risk of misunderstanding and to assure that expectations from both sides match. 

Quality of welds (per American Welding Society Gl.lOM). This document defines cracks, voids, solid inclusions, lack of fusion, and shape defects as the main categories with various subcategories. 

Major Metabolites The MIST document defines a major metabolite as one that accounts for 25% or more of the exposure to circulating drug-related material. The FDA draft guidance defines it as a metabolite in humans that accounts for plasma levels greater than 10% percent of the administered dose or systemic exposure, whichever is less. The major metabolite concept used in the FDA draft guidance refers to two types of metabolites (1) a circulating metabolite that accounts for 10% or more of the total drug-related components in the plasma, and (2) a metabolite that accounts for 10% or more of the administered dose. 

Unique Human Metabolites The FDA draft guidance document defines the term as a metabolite only in humans. The MIST document refers to a unique human metabolite as a metabolite identified in the plasma of humans but not in animals. However, it is very rare to find a truly unique human metabolite that is not formed in any animal species (Davis-Bruno and Atrakchi, 2006). 

Important Active Metabolites The MIST document defines an important active metabolite as one which is deemed to make a significant contribution to the total known pharmacological activity of a given dose of the parent compound. The FDA draft guidance document does not use this term. 

AU stakeholders should be involved in the development of the objectives document. This includes at least one representative from each type of stakeholder group. This is important because this document defines what the eventual product or system will and will not do. All subsequent development... 

The policy document defines the aims of the accreditation relative to the company the rest of the quality management system will be based on this documentation. 

To evaluate results, another key point is to define complications. The HRS expert consensus document defined a major complication as any outcome related to the procedure that is life threatening or results in death. Major complications include the development of persistent or significant disability and conditions requiring significant surgical intervention to prevent unfavorable outcome [3]. 

An obsolete ANSI standard that defined how eompanies conld record and track injuries and illnesses prior to the Occnpational Safety and Health Administration (OSH A) regnlations. This document defined terms like Permanent Total Disability, Permanent Partial Disability, and Temporary Total Disability that are used throughout safety and workers compensation literature. 

Collaborative project management The PDM system plays the role of a mediator between different partners. GSN users download the equipment order with their associated requirements, and upload the different documents defining the corresponding equipment. The PDM system notifies the partners simultaneously by subscription mechanism about the evolutions of both aircraft and equipment projects (see Sect. 16.6.2). At the end of the project, OEM validates the reception of the equipment. 

Complete list of major components, systems, structures o Framework of specifications and documentation defined a Itemized cost estimate and master schedule prepared... 

A file 61 benchmark calculations is being set up, including input card decks, output, and documentation defining the relation of the calculation to the reported experimental data. The Quality Plain requires that a selection of benchmark calculations be rerun annually to verify that no inadvertent changes have been made to either code or cross sections. 

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