Our team of American Society for Quality (ASQ) Certified Quality Auditors (CQA) can perform several types of audits to satisfy all of your needs including, but limiting on: Regulatory Compliance Assessment
Obvium Q LLC provides comprehensive regulatory compliance assessments for clients in the dietary supplements, food and pharmaceutical industries. Our team of experts is well versed in a wide variety of regulatory frameworks such as US FDA, USDA, AU TGA, EU, etc., and the emerging Food Safety Modernization Act (FSMA) regulations. One of the most important objectives of Regulatory Compliance Assessment is an unbiased view of the processes that directly impact the products and services of an organization. Poor or insufficient compliance levels is the cause for a company’s costly FDA enforcement actions and ultimately termination. Let us assess your organization and help you have a safe and secured business.
Obvium Q LLC has investigated multiple situations where a Finished Product is experiencing quality issues. In some cases, the problem occurs at their Contract Manufacturer (CM). In these situations, when using Contract Manufacturer, one of the key concerns of the Quality Assurance (QA) department of the company contracting out the work is how to demonstrate adequate oversight of the activities at the Contract Manufacturer. Additionally, the contract giver must have demonstrated assurance that the Contract Manufacturer has adequate facilities, personnel, and systems to deliver the services for which they have been contracted in compliance with current Good Manufacturing Practices (cGMPs). This requirement is even more prevalent in today’s climate with the proliferation of “virtual” companies and startups that do not have manufacturing capability of their own. When working with Contract Manufacturer, the audit is an important tool, because it ensures that current service providers are maintaining appropriate quality standards. Let Obvium Q LLC experts, without extensive background in manufacturing, perform an audit of your Contract Manufacturer’s manufacturings facility to identify the quality position and regulatory security of your product and business in general.
As a manufacturer or private label owner that provides the components or logistic support to Contract Manufacturers you are obligated to qualify your vendors in areas such as; ingredients and component suppliers, carriers and distribution centers. Similar to Contract Manufacturer qualification the contract giver must have demonstrated assurance that all vendors have adequate facilities, personnel, and systems to deliver the services for which they have been contracted in compliance with current Good Manufacturing Practices (cGMPs). Emerging Food Safety Modernization Act (FSMA) puts even more emphasis in vendor qualification process; domestically and international. Just in the Q2 and Q3 of 2013 Obvium Q LLC conducted over a dozen raw material and packaging audits for manufacturer and distributor qualifications; domestic and international (i.g., Brazil, China, Germany, Japan, Russia, Spain, etc). Due to number of vendors that each company utilizes, Vendor Qualification process can be costly. However, we are offering our clients flexible “scheduled” and “Group Audits” where audit costs are split between multiple clients.
Product Audit is the specific category of audits that focuses on a product to determine if it meets specifications. Company might request product audits if their products have had consistent problems or if they precede registration to specific market. It ensures a thorough extensive audit of each step in product life cycle from purchase order initiation to final product delivery to a customer. By thoroughly audit process, it aims at deficiency identification, improving quality, increasing profitability, and enhancing customer satisfaction and loyalty. The Product Audit ultimately serves as a benefit to the suppliers and customers by ensuring quality, which results in higher customer satisfaction.