Audit and Inspection Process and Preparation

mediSMART keeps its quality management and assurance systems, investigators and sites participating to clinical studies everytime ready for a possible system and/or site audit and inspection by regulatory agencies, IRB/IECs, FDA and/or other health authorities as well as study sponsors under comprehensive company and/or sponsor SOPs.

Beside mediSMART supports pharmaceutical companies regarding their possible system audits with its outsourcing solutions.

Audit and inspection activities performed by mediSMART are generally as below:

  • Planning for the audit and inspection
  • Preparing for the audit and inspection including quality checks of clinical documents, systems and procedures in place at the site and site staff training regarding audit and inspection activities for site audits. These include:
    • Organization
    • Training
    • Investigational Product
    • Safety
    • Monitoring
    • CRO and Sponsor
    • Central and/or Local Laboratory
    • Essential Documents
    • Project Management
  • Corrective and Preventive actions for possible audit and inspection findings
Services (All)
mediSMART Medical Research LTD Ekinciler Caddesi Elbistan Sokak Pekiz Plaza No: 5 Kat:B2 34810 KAVACIK BEYKOZ İSTANBUL TURKEY
Tel: +90 (216) 404 10 88 Fax: +90 (216) 404 10 87 ,
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