The Partnership
Was a legal firm which was retained by a company being sued for dietary supplement anomalies.
The Need
Perform a gap assessment of 26 CMO sites and contract labs to determine potential contamination sources.
Confidentiality was key to success of the project.
Coordination of gap assessment execution at 26 sites within North America.
Development of a systemic and standardized approach to execute the audits.
The Process
Evaluation of processes to make products. Assessment of potential contamination sources.
Understanding Client Needs
Determination of client goals and requirements. Establishment of program and training.
Develop Assessment Processes
Evaluation of processes to make products. Assessment of potential contamination sources.
Execution of Project
Various colleagues were coached on the process and a coordinated program was executed to audit 26 different sites across North America.
Identify Potential Source
During the execution of the project, a potential source was identified. Risk assessments confirmed it to be a likely source.
Legal Confidentiality
Full assessments of all 26 sites were compiled and provided to the legal counsel for remediation.
Successful Results
Developed program to meet our partner expectations. Coordinated execution of audits are various sites within North America. Identification of most probable cause of contamination.