Members of regulated companies are often confused about what needs to be validated when. This document sets the validation policy for your company. It identifies when equipment, processes, and computer systems need to be validated at the research, development, clinical, and commercial phases of the product lifecycle. 9 pages.

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

Price: $99.00
Product Details

  • This policy applies to all items requiring validation, including facilities, utilities, equipment, processes, quality control methods, and computerized systems that could potentially impact the purity, potency, or quality of a product, or are used for GxP functions , and/or to generate, store, manipulate or retrieve electronic quality records.
  • Policy is also stated for the purpose of validation, requirements of the validation process, the use of validated systems, retention of validation records, and supplier adherence to the policy.
  • This document is best used by companies that use computer systems throughout the product life cycle , i.e., from research through production.

It Provides information on:

  • Responsibilities.
  • Method.
  • Quality records.

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