Computer Systems Validation (CSV) / System Development Life Cycle (SDLC) Documentation Services

Change Request

Validation Plan / Protocol

Project Plan

Requirements Specification (RS)  / User Requirements Specification (URS)

Functional Requirements Specification (FRS)

Design Specification (DS) / Configuration Specification (CS)

Test Plan

Development, Functional, System Integration & User Acceptance Testing

Installation Qualification (IQ)

Operational Qualification (OQ)

Performance Qualification (PQ)

Traceability Matrix

Validation Summary Report

Release Notice

Standard Operating Procedure (SOP)