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Computer Compliance: Expectations & Experiences

Computer Compliance: Expectations & Experiences. Dr Guy Wingate Director, Global Computer Validation GlaxoSmithKline. FDA Process Analytical Technologies Sub-Committee Meeting, Washington, 23rd Oct 2002. Agenda. Background Remediation Validation Issues Part 11 Issues Summary. Background.

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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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