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[Computer system validation. The quality assurance procedure].

Valentine Anthony Sforza1

  • 1Pharma Quality Europe Srl., Via Dodecaneso 11, 00144, Roma. v.sforza@pqe.it

Annali Dell'Istituto Superiore Di Sanita
|July 19, 2002
PubMed
Summary

Computerized systems in preclinical research require validation for regulatory compliance. Quality assurance must manage diverse systems and resources to ensure data integrity and archiving.

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Area of Science:

  • Pharmacology and Toxicology
  • Biomedical Informatics

Context:

  • Increasing reliance on computerized systems in preclinical studies over the past decade.
  • Significant shifts in raw data handling and analysis methodologies.
  • Evolving regulatory landscape demanding system validation.

Purpose:

  • To outline an approach for validating computerized systems in preclinical studies.
  • To address the challenges faced by quality assurance in implementing validation processes.
  • To ensure compliance with regulatory requirements for data integrity.

Summary:

  • Computerized systems in preclinical research necessitate rigorous validation.
  • Quality assurance teams must manage diverse technologies and potential resource constraints.
  • Validation encompasses all functions, from facility management to technical operations, including crucial data archiving.

Impact:

  • Ensures regulatory compliance for preclinical data integrity.
  • Facilitates reliable and reproducible research outcomes.
  • Standardizes quality assurance practices across varied technological environments.

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