As a component of regulatory standards, quality management requires a well-designed system for controlling, monitoring and verifying any activity or process that could impact product conformance. 

Our consultants possess the experience to devise customized solutions to specific quality management issues while also providing customized training based on an organization’s unique requirements. We offer and support instruction in areas such as Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), Quality System Regulations, Medical Device Directives (MDDs), auditing and validation. 
 

Services include:

 

• Internal process and quality system audits/assessments

• Quality systems audits 

• Pre-certification audits

• Event Investigations

• Document control

• Manufacturing and production processes

• Standard Operating Procedure (SOP) development

• Process and cleaning validation protocol preparation and review 

• Supplier quality and purchasing controls

• Labeling consistency and accuracy

• Complaints, Corrective Action/Preventive Action (CAPA), Adverse Event (AE), and Medical Device Report (MDR) processes and systems

• Batch production and packaging record audits 

• Analytical data audits 

• Facility design reviews 

• Pre-FDA Inspection Readiness audits