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Computer Compliance: Expectations & Experiences

This document details Dr. Guy Wingate's presentation at the FDA Process Analytical Technologies Sub-Committee Meeting in 2002, covering background information, remediation efforts, validation issues, and insights on Part 11 issues. It discusses the impact of regulatory expectations on computer validation, challenges faced during remediation, and the evolving landscape of compliance requirements. Key takeaways include the need for proactive validation approaches, investment in new systems, and the implications of Part 11 compliance on data archiving and long-term preservation.

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Computer Compliance: Expectations & Experiences

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  1. Computer Compliance:Expectations & Experiences Dr Guy Wingate Director, Global Computer Validation GlaxoSmithKline FDA Process Analytical Technologies Sub-Committee Meeting, Washington, 23rd Oct 2002

  2. Agenda • Background • Remediation • Validation Issues • Part 11 Issues • Summary

  3. Background • Routine FDA GMP Inspection during December 1997 at UK secondary manufacturing site • Legacy system reviewed during inspection • MRP system developed in-house (custom-built) during 1980s • Several computer validation observations made • Multi-site system so corrective actions planned across other affected sites

  4. Remediation • Commitment given to FDA to validate affected computer systems (7 sites) within agreed time-scales • Global mobilisation of staff to support project • Interim measures (manual ways of working) introduced to provide parallel verification of correct systems operation - resource intensive

  5. Remediation • Initially started retrospective validation but reverse engineering did not achieve necessary standards, so replacement initiated with extensive validation including Part 11 • Replacement systems selection, project implementation, cut-over of systems for use achieved within 18 month time frame - significant investment • Ongoing dialogue with FDA

  6. Validation Issues • Retrospective validation could not achieve prospective validation standards • Batch investigation demonstrated no evidence that computer validation observations adversely impacted safety or efficacy of products

  7. Part 11 Issues • Part 11 has been a problem area with Commercial Off-The-Shelf (COTS) products not incorporating full Part 11 electronic record/signature requirements • Part 11 drives significantly more data archiving than traditionally required, and brings long-term preservation problems

  8. Summary • Regulatory expectations for computer validation have steadily increased • No grand-fathering and retrospective validation very difficult • Compliance is driving a large investment in new computer solutions • In context of risk based approach to GMP is this investment commensurate with improved product quality or efficacy?

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