We help organizations achieve and maintain compliance by ensuring their GxP IT systems meet industry standards and audit requirements. Our services include:

 

21 CFR Part 11/Annex 11 Compliance Assessments – Evaluating system compliance, identifying gaps, and ensuring adherence to regulatory requirements.

Gap Remediation – Implementing corrective actions to address compliance deficiencies and enhance system integrity.

Audit Readiness Roadmaps – Developing structured plans to help organizations proactively manage regulatory expectations.

Year-Round Validation Maintenance – Providing ongoing compliance support through:

• Mock audits to assess readiness and mitigate risks.

• Tailored training programs to enhance internal compliance knowledge.

• System audit readiness support to maintain continuous compliance.

By integrating proactive compliance strategies with robust validation services, we help organizations navigate complex regulatory landscapes with confidence, reducing risks and strengthening overall compliance frameworks.