Vista de conjunto

Tijuana, BC – Descripción y detalle de las actividades Validation monitoring to include the validation of the computer system as well as the manufacturing execution systems (MES) program. Coordinate and maintain administration of the master plan for the validation of the site’s software, including procedures, validation and revalidation templates. Manage the software inventory list in accordance with QSR part 820, 21CFR part 11. Is responsible for administering the master validation and revalidation plan of the site validation software. Ensures that all requirements of ISO 13485, QSR part 820, 21CFR part 11 related to the software control and validation plan of the site’s software master are adequately met. Responsible for keeping the site master software validation plan, validation protocol and report templates updated in NWQS. Works with the responsible departments in the annual review of the validation plan of the main software of the site. Provide training to personnel involved in the …