Quality & Regulatory Compliance Management

Companies globally are seeking new ways to improve their work processes and increase their profits.  At the same time, they must comply with strict regulatory guidelines and practice standards.  Efficiency, accuracy, safety and repeatable execution of job functions are critical factors in achieving quality results and compliant operations.

Phoenix has significant quality management and validation experience, which is strengthened by our hands-on operations, maintenance and regulatory compliance expertise.  We become an integral part of our client’s team to ensure a cost-effective solution for achieving quality and regulatory compliance.  We will develop the policies, procedures, and overall program for ensuring the total quality of the work product that meets internal, client and regulatory standards. 

Our services include the following elements of quality and regulatory compliance management:

• System Assessment and Project Management
• Development & Implementation of Quality Management Program
• Development & Implementation of Environmental Management Plan
• Development & Implementation of Validation Master Plan
• Facility/System Design, Modification & Construction Oversight
• Facility, Equipment, Process & Software Validation
• Development of Policies and Standard Operating Procedures (SOPs)
• Development & Execution of Qualification Protocols (IQ, OQ, PQ)
• Development of Corrective, Predictive & Preventative Maintenance Programs
• Calibration, Standards & Measurements
• System Commissioning & Decommissioning
• Employee Training
• Regulatory Liaison & Response
• Facility Auditing & Program Maintenance