Validation master plan for equipment hardware, computer systems, networked spreadsheet applications and legacy systems. Framework and starting point for all other validation documents.The product includes forms, checklists for quick start and implementation.
Author: Dr. Ludwig Huber Shipping: Available for download - Link will be provided in My ComplianceOnline section Source: LabCompliance
Price: $90.00
Product Detail:
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, and confidence for inspection of computer systems and data.
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.
Product Description:
Purpose and Scope of this Master Plan
Provides a framework and practices for validation and qualification of equipment, computer systems and networked systems for laboratories and manufacturing.
It also is applicable to the validation of Macros and Spreadsheet applications.
The Validation Master plan should ensure that validations and qualifications are done efficiently and consistently throughout the organization and meet regulatory, quality and business requirements.
The plan should ensure that the company's validation procedures are followed.
The company validation master plan is the basis of individual project validation plans, sometimes also called master validation plan.
Who will benefit:
The product Validation Master Plan Identifies all validation responsibilities like -
System owner
System manager
Validation team
QA
Plant maintenance/Operations/Engineering
IT
Consultants
Lab support services.
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