23.jpg
PROFESSIONAL SERVICES
Compliance Associates
Your Partner for Regulatory Compliance
4.png

For more than a decade, Compliance Associates has been successfully providing customized services and solutions to a wide variety of FDA/GxP regulated organizations. We provide products and solutions that optimize compliance and regulatory infrastructure. This helps our clients focus on their core business, innovation, the bottom line,and staying ahead of their competition.

Compliance Associates delivers solutions that are anchored in industry expertise, experience and best practices. Our customized solutions approach gives clients the freedom to choose only the services they need. Leveraging our clients’ current operating technologies and business processes provides a cost-effective means of achieving and/or exceeding compliance requirements.

Compliance Associates delivers solutions that are anchored in industry expertise, experience and best practices so that your internal resources can focus on the core business. Our approach gives clients the freedom to choose only the services needed with the potential to custom-build an integrated suite of services that best fits your company requirements. Leveraging our clients’ current operating technologies and business processes provides a cost effective means to achieving compliance requirements. We provide our clients support and invite feedback throughout the implementation process.

  • Archiving strategies

  • Clinical data management systems

  • Content and document management

  • Data collection systems

  • Electronic regulatory submissions

  • Enterprise resource planning (ERP)

  • Integrated laboratory productivity tools

  • Laboratory information management systems (LIMS)

  • Legacy Data Management

  • Paperless enterprise electronic data management

  • Computer System Validation and SDLC

  • Equipment Qualification

  • Process Validation

  • Network Qualification

  • Onsite Validation Support

  • Testing Services

CUSTOMIZED COMPLIANCE SOLUTIONS

Validation

Boosters.

What's Included?

ACCELERATE YOUR VALIDATION TIMELINE

  • The Validation Plan (VP)

  • Validation Risk Assessment (VRA)

  • Requirements Specifications (URS/FRS/DRS)

  • Installation Qualification Protocol (IQ)

  • Operational Qualification Protocol (OQ)

  • Performance Qualification Protocol (PQ)

  • Summary Reports

  • CFR Part 11 Assessment

  • Test Summary

  • Traceability Matrix