Validation Manual

Volume 1
FreeWeigh.Net V6
ME-21‘900‘937

CSV Pac - Computer System Validation

Contents

Contents

1. Purpose and Amendments

2. Non-disclosure Agreement

3. Validation Phases
3.1 Validation Phases FreeWeigh.Net

4. Quality Management
4.1 Self declaration according to GAMP4 (Supplier Audit)
4.2 21 CFR Part 11 Compliance Assessment

5. Software Development Documentation Plan

5.1 Sales, Development and Support Procedure
5.2 Software Development Process
5.3 SOP – Configuration Management

6. Software Development Specification

6.1 SOP – Document Management
6.2 User Requirements Specification (Template)
6.3 Functional Specification (Template)
6.4 SOP – Guideline for General Review
6.5 General Review Item (Template)

7. Quality Syle Guide and Procedure

7.1 SOP –Pascal Code Style Guide
7.2 SOP – Code Review

8. Test Documentation and Release Notes

8.1 SOP – Test Management
8.2 Test Protocol (Example)
8.3 SOP – Change Control Management
8.4 Release Note (Template)

9. Certificates
9.1 ISO 9001 / ISO 14001 Certificate

File: 00_2-4xe-FWN-6x_CONTENTS.doc August 16, 2010 Page 1/1

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