A System Developer's Approach to Validation

Christopher L. Gent;

Publication

Article

March 15, 2002

BioPharm International

BioPharm International-03-15-2002

Volume15

Issue 3

A System Developer's Approach to Validation

Author(s):

Christopher L. Gent

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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Guest Editorial: Warning Letters ? A Symptom?

The Importance of Freezing on Lyophilization Cycle Development

Outsourcing Outlook: Using Earned-Value Analysis for Better Project Management

Business Benefits of Computer Systems Validation

Validation of Quantitative PCR Assays?Addressing Virus Contamination Concerns

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