|Articles|March 15, 2002

BioPharm International

  • BioPharm International-03-15-2002
  • Volume 15
  • Issue 3

A System Developer's Approach to Validation

by Christopher L. Gent Pharmacia Corporation Validation is required for computer systems used to create, modify, maintain, archive, retrieve, or transmit data intended for submission. To ensure that the QA/QC and the IT departments speak the same language, a system developer will build documented evidence that a system's functionality has been tested, performs as specified, and generates reproducible results.
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Outsourcing Outlook: Using Earned-Value Analysis for Better Project Management

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Business Benefits of Computer Systems Validation

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Validation of Quantitative PCR Assays?Addressing Virus Contamination Concerns

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Additional charts for the Zeid article, "Specifications and Manufacturing Change Control"

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Specifications and Manufacturing Change Control: A Prototypic System for Electronic Document Tracking and Management

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