(FDA) A written plan stating how validation will be conducted, including test parameters, product characteristics. production equipment, and decision points on what constitutes acceptable test results. See: test plan

(FDA) Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality characteristics

(NBS) Determination of the correctness of the final program or software produced from a development project with respect to the user needs and requirements. Validation is usually accomplished by verifying each stage of the software development life cycle. See: verification, software

(FDA) Validation conducted prior to the distribution of either a new product, or product made under a revised manufacturing process, where the revisions may affect the product's characteristics

(FDA) (1) Validation of a process for a product already in distribution based upon accumulated production. testing and control data. (2) Retrospective validation can also be useful to augment initial premarket prospective validation for new products or changed processes. Test data is useful only if the methods and results are adequately specific. Whenever test data are used to demonstrate conformance to specifications, it is important that the test methodology be qualified to assure that the test results are objective and accurate

(NIST) Used as an entity to define a procedure of review, analysis, and testing throughout the software life cycle to discover errors. determine functionality, and ensure the production of quality software.

Any action, activity, or process that adds direct value to the output of the action, activity, or process / Or / Each time work is done to inputs to transform them into something of greater usefulness as an end product

An activity in a process that adds value to an output product or service, that is, the activity merits the cost of the resources it consumes in production

Those activities that transform an input into a customer-usable output. The customer can be internal or external to the organization

A cost element that varies directly with the amount of product or service produced by an activity or cost. Variable costs go to zero if the activity stops

Data that is measured on a continuous and infinite scale such as temperature, distance, and pressure rather than in discreet units or yes/no options. Variables data is used to create histograms, some control charts, and sometimes run charts / Or / Quantitative data, where measurements are used for analysis / Or / measurement information. Control charts based on variables data include average (X-bar) chart, range (R) chart, and sample standard deviation (s) chart

Procedures, techniques, and methods used to isolate one type of variation from another (for example, separating product variation from test variation)

A person or an organization that provides software and (or hardware and/or firmware and/or documentation to the user for a fee or in exchange for services. Such a firm could be a medical device manufacturer

(NIBS): In general the demonstration of consistence completeness, and correctness of the software at each stage and between each stage of the development life cycle. See: validation, software

A unique identifier used to identify software items and the related software documentation which are subject to configuration control. The execution of a virus program compromises a computer system by performing unwanted or unintended functions which may be destructive

Often incorporated into an organizational mission (or vision) statement to clarify what the organization hopes to be doing at some point in the future. The vision should act as a guide in choosing courses of action for the organization

Vision and Mission have a cause and effect relationship. Vision should reflect what the organization sees for itself 5 10 years down the road. The short time frame helps assure that the organization revitalizes itself every decade or so. The Vision statement should contain direction (improve, decrease, etc.) + indicator (quality, customer satisfaction, etc.) + target value (how much, #, %, etc.) + time limit (by when)

A term used by J. M. Juran to describe his use of the Pareto principle, which he first defined in 1950. (The principal was used much earlier in economics and inventory control methodologies.) The principle suggests that most effects come from relatively few causes; that is, 80% of the effects come from 20% of the possible causes. The 20% of the possible causes are referred to as the ‘vital few’; the remaining causes are referred to as the ‘useful many’. When Juran first defined this principle, he referred to the remaining causes as the ‘trivial many’ but realizing that no problems are trivial in quality assurance, he changed it to ‘useful many’

Statistical data that is feedback to the people in the process to make decisions about the process stability and/or capability as a tool for continuous improvement

A portion of data, together with its data carrier, that can be handled conveniently as a unit; e.g., a reel of magnetic tape, a disk pack, a floppy disk