Glossary

Confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled.

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 attributes. FDA Guidelines on General Principles of Process Validation, May 1987.

Establishing documented evidence that the system does what it purports to do.

SO 9000-3, the international guidelines for the development, supply, and maintenance of software differentiate between verification and validation.

Listing of a series of events within the life of a direct impact manufacturing system which are identified as important to create or maintain product quality over the life of the direct impact system.

Listing of a series of events within the life of a direct impact manufacturing system which are identified as important to create or maintain product quality over the life of the direct impact system.

A high level document, which establishes an umbrella validation plan for the entire project and is used as guidance to the project team for resource and technical planning.

The documented plan for qualification of a facility, or part of a facility that identifies the layout of the operation, the associated utilities and systems, the equipment, and the processes to be validated. The validation master plan also provides preliminary information as to the extent of the qualification and validation (IQ, OQ, PQ), required documentation, SOPs, acceptance criteria, and responsibilities. Validation Master Plans should also establish the cross reference of qualification projects by product, system, discipline, etc.

(PDA) A document which describes the overall strategy and responsible parties for validating a system within its operating environment.

A Quality Plan for a project with validation requirements, which describes the overall strategy for validating a system within its operating environment, seen from the user’s perspective. Sometimes called a Validation Plan or a Validation Master Plan.

(ICH Q7) A written plan stating how validation will be conducted and defining acceptance criteria. For example, the protocol for a manufacturing process identifies processing equipment, critical process parameters/operating ranges, product characteristics, sampling, and test data to be collected, number of validation runs, and acceptable test results.

A written plan describing the process to be validated, including production equipment and how validation will be conducted. Such a plan would address objective test parameters, product and process characteristics, predetermined specifications, and factors, which will determine acceptable results.

A pre-approved Test Plan for use in validation activities.

(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.

A report summarizing the results and conclusions of a validation or qualification exercise.

(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.

(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.

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.

(FDA) Validation of a process for a product already in distribution based upon accumulated production, testing and control data.

(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 lifecycle.

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