ComplianceOnline

Computer System Validation Master Plan

Computers are widely used during development and manufacturing of drugs and medical devices. Correct functioning and performance of software and computer systems play a major role in obtaining consistency, reliability and accuracy of data.

Provider: LabCompliance
Shipping: Available for download - Link will be provided in My ComplianceOnline section

Price: $90.00
Product Details

  • Computer System Validation (CSV) should be part of any good development and manufacturing practice. It is also requested by the FDA and other regulations and guidelines through the overall requirement that "equipment must be suitable for its intended use".
  • The master plan addresses computer validation at the enterprise and system level.
  • Enterprise Level : Specific contributions for enterprise level master planning are:
    • Corporate policy.
    • The company's validation approaches.
    • Inventory of systems and associated validation status.
  • System Level : Types of systems that can be covered by this plan include:
    • Commercial software and computer systems.
    • Configurable software and computer systems.
    • Small and large systems.
    • Standalone and networked systems.
  • It serves as a resource for development of computer system validation project plans. This will help make such planning more consistent and efficient.
  • Validation project plans are developed for the validation of individual systems.

It Provides information on:

  • Policy
  • Responsibilities
  • Computer Systems to be Validated
  • Validation Principle, Approach and Steps.
  • Risk Assessment
  • Configuration Management and Change Control
  • Maintenance and Support
  • System Retirement

 

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