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Inspection Dossier and Computer Systems

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  • JP
    28/05/2018 08:43
    I have posted this query on the GCP discussion forum but someone helpfully suggested also posting my query here. As part of my company's inspection preparations we have been updating our MHRA GCP inspection dossier and have come across differences of opinion with reference to completion of section 1, item 3 - Computer Systems. The differences stem from the company being mostly virtual with several vendors providing services which has led to several theories as to what needs to be included in this section. These range from just the systems the company directly manages to every single system involved in our studies including those that were implemented and are managed by external parties (e.g. EDC). Does anyone have experience or an opinion on this? Many thanks.
  • Matt Jones - Chair, DIGIT Committee
    03/06/2018 09:41
    Hi JP, From my previous knowledge, and current status, they want a listing of all systems used By the company for clinical research, especially anything that generates, holds or manipulates data required for submission. This is for reconstructability purposes. They also inspect those vendors so will want to tie in any systemic observations they see at multiple sponsors/ CROs. In meetings with regulators I’ve been in attendance in the last few weeks, it’s been stressed that they want to be able to see every electronic system, not to look into the validation etc, but to inspect for compliance with GCP e.g. in an eISF, do the documents exist in a logical format, have they been reviewed by the investigator etc. They only start looking at the validation documentation if a system is particularly difficult to use, or poses a challenge to the timelines of their inspection. They also require inspector access to those systems that replace paper based processes according to ICH GCP R2 I hope this helps, and please let me know if you need further help and guidance Best wishes Matt
  • Dympna Starling
    29/03/2019 15:02
    Hi, I am still unclear about the requirement. Take the case of a virtual company with no GxP regulated systems on its premises or directly under its control. Is the suggestion that the MHRA GCP inspection dossier requires that Sponsor to list every GxP regulated computerised system (with name, version, validation date etc.) in all the of vendor companies that had involvement in any of its trials? It does not seem to be reasonable or possible to provide accurate, detailed information on all computerised systems in use in multiple vendor companies. It is unlikely that most virtual companies are aware of this level of detail in relation to the vendors they work with and does strike me as a sensible approach to risk-base oversight. Could I ask if anyone can point to any information (training material/ blog etc) from MHRA GCP inspectors to indicate what they actually want?
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