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Page 1: Declaration of Software Validation - Agilent · P/N Declaration of Software Validation We herewith inform you that the G6861-64001, G6861-64002, G6861-64003 Product

P/N <G6861-90013>

Declaration of Software Validation

We herewith inform you that the

G6861-64001, G6861-64002, G6861-64003 Product Number

Cary WinUV version 5.0 Software, Cary WinUV Pharma version 5.0 Software,

Cary WinUV Upgrade version 5.0 Software Product Name

Software Version 5.0.x.yyyy

(where x=0-9, yyyy=0000-9999) Revision Number

was developed and tested according to the Varian New Product Development Process and the Agilent

Technologies Life Sciences & Chemical Analysis (LSCA) Group Lifecycle. Lifecycle checkpoint deliverables were reviewed and approved by management.

The product was found to meet its functional and performance specifications,

and release criteria at release to shipment.

In order to support the user’s requirements for certification of this product under 21 CFR 58 (Good Laboratory

Practice), 21 CFR 210 (Good Manufacturing Practice for Drugs), or 21 CFR 211 (current Good Manufacturing

Practice for finished pharmaceuticals), we will make the following documents available to an authorized governmental or regulatory agency for inspection

at Agilent Technologies, Spectroscopy Solutions Division, Melbourne

Product Description

Lifecycle Phase Checkpoint Approval Documents

Test Documentation

Defect Documentation

Design Documentation

Revision Status

Agilent Technologies will maintain possession of all documents and their reproductions and may require a non-disclosure agreement to be provided by those requiring access to these documents.

R&D Manager

Quality Manager

4th May 2011 Date

Page 2: Declaration of Software Validation - Agilent · P/N Declaration of Software Validation We herewith inform you that the G6861-64001, G6861-64002, G6861-64003 Product

P/N <G6861-90013>

Product Description

User documentation Product Requirements Specification

Lifecycle Phase Checkpoint Approval Documents

Product/Project Proposal Phase (Varian) Feasibility, Product Specification and Planning Phase (Varian)

Design and Implementation Phase (Varian/Agilent)

Test Phase (Agilent)

Manufacturing Release (Agilent)

Test Documentation

Test Plans Test Cases

Test Summary Report

Defect Documentation Defect Reports Defect Metrics

Design Documentation

Software Development Environment

Build Instructions

Internal Design Documentation Source Code

Revision Status

Documentation of changes by revision

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