Validating software who is erik von detten dating
In contrast, several risk-averse pharmaceutical companies choose to validate, in-depth, vendor-supplied pre-validated “standard” software.
Furthermore, it is difficult to delineate vendor and user responsibilities, when validating vendor-supplied computer systems, even those systems regarded as mature and rather relatively simple systems (e.g., MS Excel, certain enterprise resource planning software).
Computer software, as part of the computer system, dictates the hardware on which to be executed.
The software categorization typology in GAMP5 ranges from infrastructure “used-by-millions” software (category 1) such as antivirus software, operating systems (e.g., Windows, Linux, Unix, etc.), and databases (e.g., MS SQL, Oracle), to non-configured software with a large user base (category 3) such as firmware and MS Office applications, to customized software (category 5) (i.e., software characterized as being one of a kind such as most process controllers, scripts, macros, and data interfaces).
FDA issued warning letters in 2012 due to lack of documentation of intended use.
Fortunately, top management, quality executives, and engineers are becoming more aware of potential regulatory pitfalls and breaches as the industry becomes familiar with computer systems and generated data. FDA, 21 CFR 11, Electronic Records; Electronic Signatures 2.