Computer system validation

Roles and Responsibilities

CSV Compliance Assessments and determining the risk level

As applicable, prepare a milestones of Val deliverables for a Project

During CSV Concept and Planning Phase, as applicable, draft/review and approve various plans as CSV Lead -

Validation Plan

Data Integrity/Migration

Security Plan

Business Continuity Plan and Disaster Recovery Plans

Training Plan

During Requirements, Design and Build Phase - Coordinate, Review and approve

User/Functional/System/Data Migration Requirements

Functional Risk Assessment at Requirement Level

Protocols (pre and post review and approvals) - For Installation/Operation/Performance/Data Migration Qualification

Config/Design specification documents

Requirement Traceability Matrix

Standard Operating Procedures on system intended use and system administration including Data Migration

During Validation Phase - draft, collaborate, review and approve

Qualification protocol execution and reporting - IQ, OQ, PQ, DMQ in GxP sensitive environments (as applicable)

Review objective evidence at protocol level and sign-off

Testing Summary Reports

During CSV Release and Maintenance Phase - draft, collaborate, review and approve

Qualification protocols execution in Prod - IQ, PQ, DMQ

Review objective evidence at protocol level and sign-off

Validation Summary Report

Qualification/Validation of tools/utilities interacting with GxP sensitive environments

Executing CAPA procedures, drafting and approving deviation logs and keeping artifacts audit-ready in MasterControl, ALM and ServiceNow tools

Review and draft standard operating procedures the system and integrated tools refresh, upgrades, patching etc.

Project CHG management - CSV support to maintain the validated state

Key Skills: Expert with ALM and ServiceNow Tools, knowledge of MasterControl would be a bonus