Recommendation from an Auditee, VP of Regulatory Compliance and Quality Management of a CRO:
"I would like to take this opportunity to commend auditor Orit Galperin. She was auditing for ** and I cannot express strongly enough the positive impact she had on my very young and new staff. They had high anxiety concerning the audit and she came in – made a very nervous situation into a positive, learning experience. She was professional, constructive, engaging – explaining observations or deficiencies so that they learned and understood the process. For me who has over 30 years in the Quality business- it was by far the best constructive and effective audit I have been in.
Thank you from me and my staff!
Sponsor, VP of Global Quality in response to my Audit Report:
"Once again beautifully written thorough and detailed report! Thanks a bunch!!"
Sponsor, in response to my 5days Mock-Inspection Remote Audit:
"Once Again, thank you for the audit observations and many discussions and feedback points you shared. Remote auditing is a challenging endeavor. Your audit allowed us to receive a great deal of valuable experience to improve our authority inspection process so we can be better prepared when an agency remote audit will be required."
Director, GCP, R&D Quality Assurance, after a complex for-cause audit:
"Dear Orit, Thanks again.
This was a tough audit and your hard work is much appreciated.
Many thanks again, also for your patience with our questions.
You are clearly an expert 😊 and I hope we will be able to work with you again."
Associate Director, Quality Assurance
"Thank you for your effective auditing! It has been a smooth and efficient collaboration that I really appreciate."
I get this kind of thankful Auditees and Sponsors almost all the time, with no relevance to the number or severity of observations and it always leads to great collaboration and effective corrective actions. Clients/Sponsors are happy to be taken seriously and CORs Quality is improved!