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The system validation specialists.
Types of Services
Compliance Services With the frequently changing advisories and guidelines from the FDA, along with pressures on the cost of compliance and maintaining quality, it is essential to implement risk-based approaches to compliance throughout a project and during the lifecycle of a system. Additionally, life science companies must continually adapt existing and new standard operating procedures (SOPs) and training programs to ensure quality standards.

VALSPEC has the experience and expertise to evaluate and improve methodologies used during a project and in the system lifecycle. The result is a more efficient system implementation that ensures product safety and regulatory compliance. This is accomplished by assessing existing procedures and processes, organizational structure and dynamics, and the use of innovative tools to reduce costs and optimize resources. The result is that business, compliance, and quality goals are achieved.

Deliverables may include, but are not limited to:
  • Risk Assessment
  • Compliance Plan
  • Quality Plan
  • Procedures Assessment
  • 21 CFR Part 11 Assessment
  • SOPs
  • Compliance Auditing
  • Quality Auditing
  • Quality Assurance Consulting
  • Owner's Representative
  • Training
Enabling our clients to ensure the quality of their systems through well-established methodologies, which simultaneously achieve business and compliance goals.