Company is an independent consulting practice that offers complete cGMP compliant validation services that encompass packaging, software, and process validation. By combining a life cycle methodology based on GAMP guidelines and strong internal procedures such as change control, software development, and 21 CFR Part 11 compliance, the company provides flexible and diverse validation support packages for pharmaceutical and biotech applications. Capabilities include master plan preparation, and IQ/OQ/PQ protocol development/execution for a wide range of equipment, processes, cleaning, computer and automated systems. The firm’s 18,000 square foot state-of-the-art integration facility in Greenville, South Carolina is dedicated to the set-up, testing, and qualification of highly automated systems for FDA-regulated clients. Design Group has developed Validation Master Plans for NDA solid dosage facilities, computer and automated systems as well as cleaning programs. Recent process validation engagements include solid dosage manufacturing, protein purification and viral inactivation technologies, automated batching systems, and utilities. Recent computer validation engagements include LIMS software, SCADA systems, PC-based control systems, PLC- based control systems and DCS.Barry-Wehmiller Design Group, Inc918644864300
