Audit and Compliance

• “FDA like” mock audits to check health of Compliance.
• Help industry to incorporate effective Quality Management Systems and practice them in day today work.
• Review adequacy of SOPs, Validations, Qualifications to meet International guidance.
• Undertake Data Integrity verifications in manual and automated systems of documentation.
• Evolve “continuous improvement plan” for Companies in cGMP and monitor for effectiveness checks.
• Provide assistance to evolve “Simplification of GMP systems” for improved compliance.
• Institute Quality Metrics measurement techniques to reflect product quality/ system robustness within the Organization.