The Challenge of Permanent Inspection Readiness
Mediviz’s primary objective is to help attain a sustainable state of Permanent Inspection Readiness through the mock audits. To achieve this, Mediviz ensures a robust and effective Pharmaceutical Quality System is put in place and monitors the effectiveness and suitability through periodic GMP Audit and Quality Management review.
Mock Audits of the Quality Management System helps clients to face regulatory authority inspections confidently. A mock regulatory inspection is an audit conducted by Mediviz simulating a GMP Audit by a competent Regulatory authority
Mediviz works with clients in conducting a GMP Audit for their facilities, systems and / or procedures to support their systems for achieving and maintaining Permanent Inspection Readiness at site supported by advisories on preparations to face any upcoming inspection by any Regulatory Agency.
In response to a client’s needs, Mediviz’s experienced team of Auditors will conduct a GMP Audit taking a risk-based approach in accordance with ICH Q9 and Q10. Prior to audit, the team will discuss and formulate the appropriate form for the post-audit report. This report can range from a tabulation of findings to an in-depth analysis of gaps and development of a risk-based program of remediation activities.
Following the audit, Mediviz also provides further support to implement all of the client’s gap remedial activities till closure of audit observations