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Archiving requirements for electronic pharmaceutical manufacturing documents and associated executable software

T Quinn1

  • 1Hollis Group, Incorporated, Paoli, Pennsylvania.

PDA Journal of Pharmaceutical Science and Technology
|November 1, 1994
PubMed
Summary
This summary is machine-generated.

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Pharmaceutical manufacturers must plan for future access to archived electronic batch records (EBR) and electronic document management (EDM) systems. This involves creating methods and policies to recreate the necessary software environment for long-term data review.

Area of Science:

  • Pharmaceutical manufacturing technology
  • Data archival and retrieval

Background:

  • Pharmaceutical companies are adopting electronic batch record (EBR) and electronic document management (EDM) systems.
  • Significant investment is made in EBR/EDM system design, including file formats and electronic signatures.

Purpose of the Study:

  • To address the overlooked challenge of recreating operational software environments for future review of archived pharmaceutical documents.
  • To discuss strategies for ensuring long-term accessibility of electronic records.

Main Methods:

  • The paper outlines methods for ensuring future accessibility of archived electronic records.
  • It discusses policies and equipment necessary for recreating software environments.

Main Results:

Related Experiment Videos

  • Current focus on EBR/EDM system design neglects the critical aspect of future data accessibility.
  • A proactive approach is needed to plan for the recreation of operational software environments.

Conclusions:

  • Pharmaceutical manufacturers need to develop robust strategies for long-term electronic record management.
  • Planning for software environment recreation is essential for regulatory compliance and data integrity.