Definition of validating
“ The Global Harmonization Task Force GHTF, which no longer exists, has published the document GHTF SG 3 NB 04 now "administered" by IMDRF.
Likewise, the Central Authority of the Länder ZLG has published a document labeled ZLG 3.9 B 18 and titled "Validation of Processes of Production and Providing Services (including Software)".
It is used only for the audit of a validated process.
Concurrent validation is used for establishing documented evidence that a facility and processes do what they purport to do, based on information generated during actual imputation of the process.
This is achieved through data validation's checks and rules that routinely check for the validity of data.
These rules are generally defined in a data dictionary or are implemented through data validation software.
Stage 3 – Continued Process Verification: Ongoing assurance is gained during routine production that the process remains in a state of control.
The guidelines on general principles of process validation mentions four types of validation: A) Prospective validation (or premarket validation) B) Retrospective validation C) Concurrent validation D) Revalidation Establishing documented evidence prior to process implementation that a system does what it proposed to do based on preplanned protocols.
If we combine both definitions, it becomes clear that a process validation provides a confirmation of a process leading to the intended process results by objective evidence For instance, in case of a development process one would ascertain that the development outcomes meet the requirements ("Design Input").Retrospective validation is used for facilities, processes, and process controls in operation use that have not undergone a formally documented validation process.Validation of these facilities, processes, and process controls is possible using historical data to provide the necessary documentary evidence that the process is doing what it is believed to do.Reinforcing and validating the values of goods are the social values of men.How far may we trust our experience as validating the inferences we draw from it?