Managed Service Solution for Annual Product Review (APR)
Download a . PDF of this Case Study here:Managed Service Solutions for Annual Product Review (APR) Client Business Situation Client was experiencing multiple problems with its Annual Product Review (APR) process for its externally manufactured products, which included OTC Pharmaceuticals, Cosmetics, and Medical Devices (See Note). Client was also exceeding its budget for the execution […]
SharePoint® Quality & Compliance Metrics Reporting
Download a .PDF of this Case Study here:SharePoint® Quality & Compliance Metrics Reporting Client Business Situation Client was trying to manage a complex enterprise enforcement remediation activity without the benefit of useable information on quality systems’ metrics or quality system effectiveness. Most site quality information was being collected on Microsoft Excel spreadsheets, with much difficulty, […]
Compliance Risk Assessment and Remediation Portfolio Management Solution
Client Business Situation Client Company had experienced multiple enforcement interactions with the US Food and Drug Administration in its recent history. As a result of a number of specific, related enforcement activities, client’s business operations were being significantly impacted with revenue and profitability down sharply. When Client Company initially approached Compliance Architects® for assistance, it […]
