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, […]
OTC Pharma Warning Letter Response Assistance
Client Business Situation This client company was a long-established, family-owned, manufacturer of dietary supplements and OTC pharmaceuticals, with a long, and unfortunately poor history of compliance with the US FDA. The company had also been experiencing problems with customer fulfillment and product quality. Client Business Pain After a particularly aggressive FDA inspection, the client received […]
Medical Device Warning Letter Remediation Assistance
Client Business Situation Client was a long-established manufacturer of class II durable medical devices designed for mobility assistance. Due to challenging competitive and other market conditions, client had made a decision within the last five years to move manufacturing from a domestically-based operation to an overseas contract manufacturer. Client Business Pain Significant FDA enforcement action […]
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 […]
AFHCAN Medical Device Data Systems (MDDS) Quality System Assessment
Client Business Situation AFHCAN (Alaska Federal Health Care Access Network), an organizational unit of the Alaska Native Tribal Health Consortium (ANTHC) is an organization dedicated to improving the healthcare delivery of the native Alaskan population through a diversified healthcare delivery model. AFHCAN, as part of its overall mission, has developed innovative and proprietary medical device data systems (MDDS) […]
Consumer Device Inspection Readiness
Client Business Situation A leading high-volume manufacturer of consumer medical devices located outside of the United States was experiencing increased concern regarding their regulatory compliance enforcement profile. Factors contributing to this increasing concern included strong enforcement actions at a sister division and known deficiencies in multiple aspects of the company’s quality systems identified through internal […]
