Computerized System / CSV Audits
Independent audits to assess computerized-system compliance, strengthen data governance, and protect the integrity, security, and reliability of GxP data
Explore Service →
Our Services
GxP Audits & Assessments
Independent, risk-based audits and compliance assessments to strengthen quality systems, identify regulatory gaps, and support inspection readiness.
Overview
In regulated industries, effective audits are essential for evaluating the strength of quality systems, identifying compliance risks, and ensuring that facilities, processes, suppliers, and computerized systems continue to meet applicable GxP requirements.
Mediature GxP Solutions Pvt. Ltd. (MGS) provides independent GxP audit and assessment services to pharmaceutical, biopharmaceutical, API, medical-device, clinical, laboratory, distribution, and other regulated organizations.
Our multidisciplinary audit team combines quality, regulatory, engineering, validation, laboratory, computerized-system, and pharmacovigilance expertise to provide a comprehensive view of compliance.
MGS audits are designed not only to identify gaps, but also to help clients understand their significance, prioritize remediation, strengthen systems, and maintain ongoing regulatory readiness.
Our GxP Audits & Assessments Services
GVP / Pharmacovigilance Audits
Independent pharmacovigilance audits to assess system compliance, strengthen safety processes, and support regulatory inspection readiness.
Explore Service →
GMP Audits
Independent GMP audits to identify compliance gaps, strengthen quality systems, and support continuous inspection readiness.
Explore Service →
GDP Audits
Independent GDP audits to strengthen storage, transportation, traceability, and distribution controls across the pharmaceutical supply chain.
Explore Service →
Vendor and Supplier Audits
Independent supplier and vendor audits to strengthen qualification, oversight, and compliance across outsourced GxP activities.
Explore Service →
GLP Audits
Independent GLP audits to strengthen laboratory quality systems, protect data integrity, and support regulatory readiness.
Explore Service →
GCP Audits
Independent GCP audits to protect participant rights, strengthen clinical quality systems, and support inspection readiness.
Explore Service →
Quality System Audits
Independent quality-system audits to identify compliance gaps, strengthen QMS effectiveness, and support sustained regulatory readiness.
Explore Service →
Engineering Compliance Audits
Independent audits to assess facility design, engineering systems, utilities, maintenance, qualification status, and GMP compliance across regulated operations.
Explore Service →
Factory Acceptance Testing (FAT) Audits / Witnessing
Independent FAT audit and witnessing support to verify equipment compliance, functionality, documentation, and readiness before shipment to the user site.
Explore Service →
Due Diligence / Gap Assessments
Independent assessments to identify compliance risks, evaluate operational readiness, and support informed business and investment decisions.
Explore Service →