Now days we customize to the Global Need of NO TRAVELING - REMOTE AUDITS
We developed effective tools for Remote Audits:
1. Setting-up effective communication and collaboration with the audited sites
2. Setting an appropriate Agenda for the Remote Audit - With experience working with different time zones.
3. Detailed Questionnaires; sending the site a questionnaire, in advance, and discussion during the audit
4. Conference calls; interviews with key personnel
5. Sharing documents and access to computerised systems, where possible
6. Reporting; evaluated benefits and risks of Remote Audit
So these audits can be REMOTELY:
Qualification / Re-qualification Audits of CROs/Laboratories and other Vendors
Study Based Audits; by review the Study Protocol/Amendments/ Deviations/Study Notes and interview with the Study Director/ Project Manager
For Cause Audit; investigation via interviews and documentation review
Note that Global Pharma QA have done hundreds of audits and familiar with the many CROs procedures which make these REMOTE AUDITS much simple and effective!
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