The validation process is undertaken to ensure that every part of the automated software that Distinct Software Solutions develops is produced using a validated method. This will be completed by using either one of GAMP 5 or cGxP. For this service, all pharmaceutical industry work is undertaken; please contact us for more details and information.

    GAMP 5

– Good Automated Manufacturing Practice (GAMP) is both a technical subcommittee of the International Society for Pharmaceutical Engineering (ISPE) and a set of guidelines for manufacturers and users of automated systems in the pharmaceutical industry.

GAMP5
FDA1

    cGxP

– Current Good X Practice (X=variable e.g. manufacturing, engineering, clinical, distribution etc.). This is referring to the regulations established by the United States Food and Drug Administration which are published in the Code of Federal Regulations.

FDA