Before You Build

Compliance Policies, Manual, Standards, Procedures, etc.

VQS will establish, document and implement a Quality Management System (QMS) in accordance with industry requirements. The system is maintained and continually improved through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive action and management review.   VQS will help you: 


  • Identify the processes needed for the QMS and their application throughout the organization and documented them. 
  • Determined the sequence and interaction of these processes. 
  • Determined criteria and methods needed to ensure that the operation and control of the processes are effective. 
  • Ensured the continuing availability of resources and information necessary to achieve planned results and continual improvement of these processes  
  • Established systems to monitor, measure and analyze these processes, a 
  • Established processes to identify and implement actions necessary to achieve planned results and continual improvement of these processes. 
  • Documented Quality Policy and Quality Objectives. 
  • Develop a Quality Manual 
  • Develop Procedures and Templates for Quality Records 
  • Documents identified as needed for the effective planning, operation and control of your processes.

Quality Systems CAPA, Audits, Metrics, Risk, Change Control, Incident Mgt

 In the life sciences industry, the process of managing non-conformities or defects from manufacturing, engineering, quality or other quality data sources, such as product complaints leading to corrective or preventive actions, should be a formal and controlled process that is used to identify, correct and prevent problems. Today, the industry is facing strong pressure from regulatory bodies—government as well as from the industry itself—to focus on quality and, at the same time, the need to increase asset utilization and efficiencies, and lower cost as much as possible. A corrective and preventive action (CAPA) program is one tool to achieve these objectives. A key part of a CAPA program is root cause analysis, which is utilized to ascertain the source of a problem, non-conformity or defect so that corrective or preventive action can be taken to address the issue.   If you are conducting: GRC/ Quality Assurance/Regulatory Affairs directive especially in, Quality Management/System initiatives in Training, Change Management, Audits, Inspections, CAPA, Risk Management, Document Control, Product Specifications, Returns, Document Management, Inspections, Walkdowns, etc. VQS will help you to easily manage all aspects of your organization’s quality program. This includes but not limited to:

  

Defect Tracking 

Supplier Nonconformance 

Quality Objectives and Targets 

Customer Management 

Customer Complaints 

Supplier Management