Quality Assurance - Part One: The QA Team

WDSrx
561-998-3885
http://www.wdsrx.com

Quality Assurance – The QA Team

The Quality System at WDSrx refers to an organized set of procedures and practices that assure consistent application of regulatory requirements within an organization established by government, industry authorities and clients. The Quality Assurance team develops, approves and oversees the Quality System to assure compliance with cGMP and cGDP regulations. At WDSrx the experienced Quality Team consists of a Quality Assurance Manager, a Quality Assurance Specialist, a Quality Control Inspector and two Document Control Specialists. Because the Quality Assurance team evaluates business operations, it functions as an independent authority reporting directly to WDSrx President Adam Runsdorf.

The WDSrx QA department updates and archives documentation including personnel, equipment, process controls, records, licensing and certifications at all facilities. Documentation adequately listing all products, each product's storage conditions and transportation requirements varies by client and is stipulated in individual Quality Agreements. WDSrx complies with the Code of Federal Regulations detailed in 21 CFR 210 and 211 for handling and distribution of pharmaceutical drug products. Training is conducted regularly according to Standard Operating Procedures, or SOPs. All employees are required to read and understand all SOP documents related to their work.

Another important role of the WDSrx QA department is to take action upon any deviation from established practices. When issues arise, the QA team assesses data, investigates the issue’s origins, conducts an investigation and determines a resolution to further a culture of continuous improvement. This process is called CAPA, short for Corrective Action/Preventive Action. By evaluating the cause of problems, analyzing data and implementing changes, operations are maintained with a focus on continuous improvement for enhanced efficiency.

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