Quality Management System Development

Increasing complexity in the Global Regulatory landscape challenges companies to maintain resources necessary to focus on continuous improvement.

Effective, efficient Quality Management Systems meet all necessary compliance requirements. Drive continuous improvement activities, while contributing to the ultimate success of the team, the product and the company.

The Approach.

Be proactive. Proactive effort is the cornerstone of a strong Quality Management System. It is fundamental to efficient, profitable businesses.

ValSource delivers robust Quality Management Systems intelligence, while simultaneously solving problems and transferring knowledge. Build custom, intuitive QMS programs that balance proactive and reactive quality work. We assess your processes, while providing actionable feedback. Execute comprehensive, targeted remediation plans.

ValSource emphasizes the following areas within the product lifecycle:

  • Quality Manual & governance policy development
  • Process performance & product quality monitoring system
  • Deviation management
  • Change management
  • CAPA system development and implementation
  • Audits/self-inspections
  • Management review
  • Quality culture development

The Pains.

Regulatory citations

Delays in product approvals

Open investigations and CAPAs

Deviations

Excessive or inadequate controls

Inefficient use of budget and resources

The Relief.

Effective audits and understanding of expectations

Risk and science based Line of Sight approach

Organized knowledge management systems

Quality culture development and change management

Process performance & product quality monitoring

Resources and budget focused on the important issues first