Remote Good Clinical Practice (GCP) Vendor Audit (Princeton, NJ)

The primary purpose of this GCP Vendor Audit was to determine the capabilities of this vendor to provide Good Clinical Practice (GCP) services for sponsored studies in accordance with GCP regulations and requirements. Additionally, this GCP Vendor Audit is conducted to verify that vendor has the necessary Quality Systems in place to maintain contract services needed to support the maintenance, provision, integrity and security of Clinical development for current and future projects. Auditor- Heather M.

Remote audit SAAS provider (Minneapolis, Minnesota)

Remote qualification audit of a global SAAS provider in Minneapolis, Minnesota

QualRS conducted an audit of a SaaS provide on behalf of a trailblazing mid-size South-San Francisco pharma company. QualRS ensured compliance in several areas, including, but not limited to Security, Risk Management, and Data Privacy.

Compliance is an essential aspect of any SaaS provider audit. So our audit ensured that the SaaS provider was compliant with all relevant regulations, including HIPAA and GDPR. Auditor-Zeina K.

On-site GMP audit of API manufacturer (San Diego, Ca.)

 The purpose of this qualification audit was to determine the general compliance and capabilities of this manufacturer to perform API production and verify their quality systems and compliance with the applicable regulations in order to provide Good Manufacturing Practice (GMP) services for our client’s sponsored studies in accordance with GMP regulations and client;s requirements. Auditor-Robert F.

On-site GCP audit of CRO (Beijing, China)

This GCP audit was aimed at evaluating the compliance status of quality operations at this facility which provides CRO services (clinical data management and statistics service) in support of the Sponsor’s drug development. Auditor-Stephanie C.

Investigator Site Audit (Brookvale, NSW, Australia)

Investigator Site Audit to ensure and asses that: (i) the rights, well-being and safety of the research subjects have been protected; (ii) study activities have been conducted in compliance with the protocol, study procedures, written instructions, Good Clinical Practice Guidelines, and applicable regulatory requirements; and (iii) data is accurate. Auditor-Leila M.