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  • Validation of Computer Software and GAMP 5 Guide

    I have been reviewing your “Procedure for Documentation and Validation of Computer Software”, and want to know if it meets the ISO 13485 Computer System Validation (CSV) requirements?  Also, does it take the GAMP 5 Guide (Compliant GxP Computerized System) into consideration?

  • Validating Conformio software

    Hello, I have a question whether Conformio software has to be validated as per ISO 13485:2016 requirements, Clauses 4.1.6 and 7.5.6, and if it has to be validated what is the best way to do it?
  • Do people working in departments excluded from scope have to be trained for QMS?

    I have a question regarding how to decide if a person needs to be trained in various parts of a QMS set up for 13485:2016 compliance. People processing medical device have to be trained. But what about a person for example in marketing, who has nothing to do with any part of the work affecting product quality. Do people working in departments excluded from the scope of the QMS (for example finance, legal, marketing) have to be trained in various procedures contained in the quality manual?

  • Would becoming ISO 13485 compliant benefit customers more than ISO 9001?

    We manufacture machines that are not subject to FDA oversight. However, our customers use them in an FDA regulated environment. Would our becoming ISO 13485 compliant benefit our customers more than an ISO 9001 certification?
  • Production data in 8.2.1 Feedback

    Sec. 8.2.1 feedback- contains a requirement to document the requirement for the feedback process. "This feedback process shall include provisions to gather data from production as well as post-production activities." While customer feedback of post-production activity is well understood, my question is related to the production data. what is expected from production data with regards to the feedback process? Dose is related to how the company react and respond to feedback and trends
  • What is the role of the process owner?

    Document Management - what is the role of the process owner?
  • Product recall requirements and Drinking water standard in Cambodia

    "I want to know the regulatory requirements for Product recall in Cambodia. Kindly include Standard plant water requirements for Cambodia and treatment water requirements in Cambodia. Thank you."
  • How to mark and identify Company Policies?

    New to QA Manager. Previous QA Manager made it mandatory for Position Descriptions in HR department, as well as Company Policies i.e Health & Safety, Social Media Policy to be version & document ID controlled. It is mandatory for those types of documents to have a document ID, version number and review date?
  • Documents within the Quality Manual Handbook

    Hi may I ask you for advice, is it possible and wise to have all documents related to system in Quality manual handbook?
  • Complaints handling and corrective actions

    Does a formal CAPA is always needed when complaints investigation results with corrective action task? or can it be included as part of the complaint activity and follow up? also if CAPA was assigned, can Complaint be closed?
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