Suzanne Richardson,
https://www.linkedin.com/in/rxtext/Good luck!
------------------------------
Andrea Chamblee Esq., RAC, FRAPS
Senior Counsel, Wilson Sonsini
This information and views expressed are provided in my capacity as an FDA and compliance professor at Johns Hopkins and George Washington universities, and as a RAPS Fellow.
This is not intended as legal advice. Consult a lawyer for your specific matter.
Maryland
United States
------------------------------
Original Message:
Sent: 12-Apr-2022 08:28
From: Sara Guyler
Subject: Looking for an eClinical 3rd party auditor
Hello,
I am looking for a 3rd party auditor to review our company's eClinical services (eSignatures, eTMF/eISF, eConsent) and audit is against US FDA Part 11 and EU Annex 11 (and potentially future similar global regulations) to provide a certificate of technical compliance with these requirements. If an auditor also has experience in privacy regulations (HIPAA, GDPR), we would be interested in expanding the scope of the audit to cover those areas as well. Does anyone have this experience or have a recommendation of someone who does?
------------------------------
Sara Guyler
Policy Manager
United States
------------------------------