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Creating a QMS from the ground up



  • Hannah
    14/02/2019 22:21
    Hello everyone, I have been given a great opportunity to create, implement and design as robust QMS for a non-profit clinical trials organisation. I have create a 12-18 month action plan which will evolve and adapt as time goes on. I am open to ideas and suggestions from other QA professionals. It's like a QA Dream to create their ultimate QMS. Please note I am in Australia so some of the rules and regs are vastly different (mind boggling tbh) to the the rest of the world, but I can still tailor and adapt to this setting. Currently on high on the list is SOPs redesigned - user friendly QA Templates Vendor Management Program Training Management System QC and Controlled documentation Really starting from scratch. It would be greatly appreciated if I could hear everyone's suggestions on their ideal QMS. Look forward to hearing from you all, Kind Regards, Hannah
  • GCP Com
    15/02/2019 14:13
    One suggestion from a GCP Committee member would be that she follows the principles of ISO9001;2015. Appreciating the organisation might not want to go for the full accreditation it provides a solid foundation for a QMS, but it requires a certain level of knowledge and experience to be able take those principles and translate them into a QMS that would work and add value to the organisation. > one size does not fit all and one person’s dream could be another person’s nightmare!
  • Colin Wilsher
    15/02/2019 15:04
    RQA has a Quality Systems Guide that you might find useful
  • Colin Wilsher
    15/02/2019 15:08
    In 2014 the RQA GCP Committee answered this question and it is in the Q & A page. (thanks to Monjit) Developing a Clinical Trial Quality Management System and SOPs for new Sponsors https://www.therqa.com/good-practices/good-clinical-practice/questions-and-answers/quality-management-system/
  • GMP Commitee
    08/03/2019 17:35
    As already referenced there is an RQA QMS guide on the website, which would be a good starting point. In addition, work from the regulatory/customer standards that you must acheive and define your high level policies (as a manual or individually). These will outline what needs to be defined in SOPs and Work Instructions depending on how you consider best to constrtuct the QMS. This will direct you on the build and detail. Ensure relevant cross functional team members are inlcluded in the development and then you will have the best current intended practice that has been bought into and of course then review and refine.
  • GMP Committee
    08/03/2019 17:37
    Sorry meant to add - better to start from the top and down to the ground
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