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Validation Consultants LLC

Regulatory Compliance,
CSV & Auditing

We are experts in CSV - computer systems validation - and are dedicated to helping companies address the regulatory requirements of FDA 21 CFR Part 11, 21 CFR Part 820 and ISO 13485.

 

Pharmaceutical, biological products and medical device manufacturers use our services to streamline processes, ensure data security and verify compliance with FDA regulations for the use of electronic data. 

Our Services

Our Servuces
QA Testing for Compliance 

Implement quality systems to test software functionality, track issues and control releases in GCP, GLP & GMP contexts.

21 CFR Part 11 Compliance

Assess status, define & implement processes, and document & test procedures to ensure compliance.

QSR for Medical Devices

Assess, define & implement processes and document & test procedures to ensure ISO 13485 and QSR 21 CFR Part 820 compliance.

GxP & Compliance Auditing

Assess software and computer systems to identify issues and ensure compliance with business and FDA requirements.

CSV: Computer System Software, Process & Equipment Validation

Ensure that all controlled processes

and systems are in compliance with applicable regulations.

Software Development Life Cycle (SDLC)

Produce SDLC documentation and test plans in compliance with FDA regulations. 

Contact

Ready to find out more?

We're ready to work with you to address your validation, quality assurance and compliance issues. Contact us and we'll schedule a conversation to learn more about your immediate needs and explore how we can help.

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