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 Compliance Associates Services

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Your Partner for Regulatory Compliance

Compliance Associates

For over a decade, Compliance Associates has been successfully providing customized services and solutions to a wide range of FDA/GxP regulated organizations. Our products and solutions optimize compliance and regulatory infrastructure, allowing our clients to focus on their core business, innovation, bottom line, and staying ahead of the competition.

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Compliance Associates delivers solutions anchored in industry expertise, experience, and best practices. Our customized approach allows clients to select only the services they need. By leveraging our clients’ existing technologies and business processes, we offer a cost-effective means of achieving and exceeding compliance requirements.

Customized Compliance Solutions

Compliance Associates delivers solutions anchored in industry expertise, experience, and best practices, allowing your internal resources to focus on the core business. Our approach offers clients the freedom to select only the necessary services, with the option to custom-build an integrated suite tailored to your company's requirements. By leveraging clients’ existing technologies and business processes, we provide a cost-effective means to achieve compliance requirements. We support our clients and welcome feedback throughout the implementation process.​

Our Services Include:

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  • 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

Validation Boosters

Accelerate your validation timeline

Whats Included?

  • 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

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