Good Clinical Practice Guide
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Thread: Validation Responsibilities

  1. #1
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    Jun 2021
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    Validation Responsibilities

    Hi there,

    Can anybody shed some light on QA responsibilities around csv projects,

    Do regualtory bodies expect QA to have the final say/approval before software is released and be impartial to other departments with concern to validation deliverables ?

  2. #2
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    Nov 2011
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    There are some interesting daft guidance that might help. EMA Guideline on computerised systems and electronic data in clinical trials June 2021. and FDA Digital Health Technologies for Remote Data Acquisition in Clinical Investigations Guidance for Industry, Investigators, and Other Stakeholders DRAFT GUIDANCE Dec 2021. Also the MHRA GCP guide 2012 has stuff on CSV and fit for purpose systems requirements. Also the EMA IWG website has stuff on computer systems in CTs https://www.ema.europa.eu/en/human-r...l-practice-gcp. Also the RQA www.theRQA.com has a whole section about computer systems and a discussion forum on computers in CTs and they run lots of seminars etc https://www.therqa.com/good-practices/it/

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