Documentation: Supporting Document

This document is intended to define computerised systems direct and indirect regulatory impact for the teams applying risk based approach to CSV. This document applies to all regulated computerised systems (CS) as defined in the Roche Computerised System Validation Policy (pol000014).

The purpose of this document is to be an implementation aid to ensure that all system requirements needed to fulfill ERES (Electronic Record Electronic Signature) regulations are included as part of the Requirements Specifications/User Stories activities. The ERES requirements should be incorporated

This guideline supports the use of Agile frameworks in the implementation and maintenance of computerized systems used to support GxP business processes and data. The guideline specifically addresses product delivery that spans across project and operational changes.

and Purpose This standard refines the requirements as defined in the Roche GxP Data Integrity Policy (GOV0100156 Roche GxP Data Integrity Policy) and describes means of implementation.