Validation Master Plan

For Efficiency, Consistency and FDA Compliance

Intro

 

• Saves time and increases confidence for inspections
• The single most important validation document
• Framework and starting point for all other validation documents
• Includes chapter on network qualification
• With chapter on legacy systems
• With chapter on Macros and Spreadsheets
• Includes forms and checklists for quick start and implementation

Important: A validation master plan is the single most important document to defend your validation strategy during inspections

Regulatory agencies (e.g. US FDA) want to know your approach towards validation. A validation master plan is the ideal tool and it makes validation of computer systems and other equipment more effective. It is the single most important validation document to improve

• consistency of validation throughout your organization
• efficiency in your lab through reuse of templates
• confidence for inspection of computer systems and data

A validation master plan is also the basis for individual project validation plans.

This model master plan written by Dr. Ludwig Huber is both concise and comprehensive. Whether you use it as it is or as a template for customization: it saves time and increases confidence for inspections.

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Package Overview

1. Scope

2. Introduction

3. Responsibilities

• Validation team
• Lab operations
• Plant safety/maintenance/engineering
• Information Services (IS)
• Quality Assurance (QA)
• Laboratory management
• System owner

4. Related documents

5. Products/processes to be validated and/or qualified

6. Validation approach

7. Steps for Equipment Qualification

• User requirement and functional specifications
• Vendor assessment
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance qualification (PQ)
• Change control
• Documentation

8. Computer system validation

• Design qualification
• Vendor qualification
• Installation qualification
• Operational Qualification (OQ)
• Performance qualification (PQ)

9. Networked Systems

10. Existing/Legacy Systems

11. Validation of Macros

• Responsible persons
• Tasks
• Functions
• Design and implementation
• Testing
• Ongoing performance checks
• User documentation
• Security

12. Change Control

13. Instrument Obsolescence and Removal

14. Documentation maintenance

15. Glossary

Appendix A.

• Forms
• Checklists

Target Audience

• Lab managers and personnel
• IT managers and personnel
• QA managers and personnel
• Analytical scientists
• Validation specialists
• Consultants
• Vendors
• Teachers

Format/Price/Ordering

• Format: Electronic PDF, MS Word also available on request
• Size: 40 Pages
• Price: US$ 90.-
• VAT will be added for EU countries.
• Availability: Worldwide, shipment within one working day
• Ordering: (SSL secured, recommended for payment by credit card)
  - Electronically from this this web site (SSL secured)
• - Regular mail or fax using the form in PDF or MS Word format

The author

The author, Dr. Ludwig Huber, is an international expert on validation and compliance in laboratories. He has been responsible for the compliance program at Hewlett Packard and Agilent Technologies for more than ten years. He serves as a consultant for the industry and regulatory agencies on laboratory compliance issues. He has been a member of the US PDA task force on 21 CFR Part11 and of the GAMP Special Interest Group for Laboratory Equipment. He is also on the advisory board for the European Compliance Academy. Several of his previous books have been bestsellers and several times he has been ranked as number one presenter at various international conferences on validation and 21 CFR Part 11. For publications, presentations and other achievements, click here