Definitions demand intake

OTS

Off the shelf

Validation

Validation is delivering a documented evidence that a computer application, software, or solution met its defined intended uses and/or user needs/expectations. Different kind of validations are: Prospective validation: usually called validation. It is a validation prior to the usage of a software in its intended use.

Retrospective validation: is done for a system after its go-live
E.g. -changes in the regulatory environment requires it to be validated - an already validated system in which the initial validation was not sufficiently executed and or documented.

Revalidation

revalidation as per defined criteria. Criteria are defined inside this procedure.

Verification Verification is delivering a documented evidence that confirms the accuracy or truth of predefined requirements Application

Owner

Individual responsible for the overall procurement, development, integration, modification, operation, maintenance, and retirement of a software.
IT Quality IT representative from IT Quality team.
Shared responsibility with the QMS team to: - maintain the Overview list and generate the local MVP (Overview list) when needed. - To provide guidance to the application Owner and validation team on the validation process described inside this procedure QMS Quality representative from QMS team. Shared responsibility with the IT Quality team to: - maintain the Overview list and generate the local MVP (Overview list) when needed. - To provide guidance to the application Owner and validation team on the validation process described inside this procedure D00218147 [7] The Overview list is a working file. Once the file is updates as per process flow described in this procedure a global or country specific MVP (Master Validation Plan also known and named as Overview list) can be generated / updated. History report History Report is required for retrospective validation due to specific condition such as for systems that went live before validation. MVP The terminology MVP is used to describe a document listing down all application in an Affiliate. The MVP can also be names as Overview list.