Audit Services

Professional auditing solutions that help organizations meet internationally-recognized standards, resulting in improved quality, operational effectiveness, and efficiency.

Professional audit and compliance review process

Expert Audit Solutions

Acennix has a team of professional and qualified auditors who adhere to ISO 19011 standards and are familiar with the special requirements of the pharmaceutical and biomedical sciences industry.

Our auditors are IRCA certified with extensive experience in auditing quality management systems. We have provided auditing services to MNCs, research institutes, and laboratories throughout Asia and Europe.

Comprehensive audit solutions

Our Audit Services

Comprehensive auditing solutions designed to ensure compliance, improve quality, and prepare for regulatory inspections.

Self Inspection Audits

Comprehensive internal audits of facilities, procedures, and processes to ensure compliance with GMP requirements and identify improvement opportunities.

  • • Facility and equipment audits
  • • Process and procedure reviews
  • • Compliance gap analysis
  • • Corrective action planning

Supplier Audits

Thorough evaluation of pharmaceutical suppliers to ensure they follow the IQA code of practice and meet your quality standards.

  • • Supplier qualification audits
  • • Quality system assessments
  • • Regulatory compliance reviews
  • • Risk-based supplier evaluation

Due Diligence Audits

Comprehensive assessments for potential suppliers or acquisitions, evaluating quality systems, compliance, and business risks.

  • • Pre-acquisition assessments
  • • Quality system evaluations
  • • Regulatory compliance reviews
  • • Risk assessment and mitigation

ISO 9000 System Audits

Comprehensive ISO 9000:2000 system audits to ensure quality management systems meet international standards and regulatory requirements.

  • • ISO 9001 compliance audits
  • • Quality management system reviews
  • • Process effectiveness assessments
  • • Continuous improvement planning

Mock Regulatory Audits

Simulated FDA or MHRA audits to prepare your organization for regulatory inspections and identify potential compliance issues.

  • • Mock FDA inspections
  • • MHRA audit simulations
  • • Regulatory readiness assessment
  • • Inspection preparation training

Quality Risk Management

Comprehensive risk assessment and management services to identify, evaluate, and mitigate quality and compliance risks.

  • • Risk identification and assessment
  • • Risk mitigation strategies
  • • Quality risk management systems
  • • Risk monitoring and review

Our Auditor Qualifications

Our team of professional auditors brings extensive experience and internationally recognized certifications to every audit engagement.

IRCA Certified

International Register of Certificated Auditors

ISO 19011 Compliant

International auditing standards

Industry Experience

Pharmaceutical & biomedical expertise

Global Reach

Asia and Europe experience

Ensure Compliance Excellence

Let our certified auditors help you maintain the highest standards of quality and compliance. Contact us to discuss your auditing needs.

Schedule Your Audit