AUDIT & GMP COMPLIANCE
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AUDIT & GMP COMPLIANCE
End-to-end audit and compliance services to ensure your organization is always audit-ready and meets global regulatory standards.
Gap Assessment for GxP Systems
Comprehensive gap assessments to evaluate your current state of compliance against regulatory requirements and industry best practices.
- Data Integrity Gap Analysis for computerized systems and manual processes
- 21 CFR Part 11 and EU Annex 11 compliance gap assessments
- System-level assessments for manufacturing, laboratory, and engineering systems
- Remediation planning with prioritized action items and timelines
- Gap closure tracking and re-assessment
GMP/GLP Audit
Expert audit services to evaluate your compliance with Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) requirements.
- Internal GMP/GLP audits with detailed findings and recommendations
- Pre-regulatory inspection readiness assessments
- Computerized system audits and IT compliance reviews
- CAPA management and corrective action follow-through
- Mock audit programs to prepare your team for regulatory inspections
Regulatory and Quality Compliance (QMS Implementation)
Supporting organizations in building and maintaining robust Quality Management Systems that meet regulatory expectations.
- QMS design, implementation, and continuous improvement
- Change management and deviation handling procedures
- Document control system setup and management
- Training programs on quality management and compliance
Vendor Audit / Third-Party Audit
Evaluating your vendors and third-party service providers to ensure they meet the quality and compliance standards your organization requires.
- Vendor qualification and assessment programs
- On-site and remote vendor audits
- Third-party software and service provider compliance evaluation
- Supplier quality agreements and oversight frameworks
- Ongoing vendor performance monitoring
Audit Compliance (ISO 9001, ISO 27001, ISO 13485)
Specialized support for achieving and maintaining ISO certification across your organization.
- ISO 9001:2015 — Quality Management System implementation and audit readiness
- ISO 27001 — Information Security Management System (ISMS) support and compliance
- ISO 13485 — Medical Device Quality Management System implementation
- Internal audit programs aligned with ISO standards
- Management review preparation and certification support
Regulatory Support
Ongoing regulatory intelligence and support to keep your organization aligned with evolving global standards.
- Regulatory intelligence monitoring for FDA, EMA, WHO, and other agencies
- Impact assessment for new or updated regulations
- Regulatory submission support and documentation
- Inspection readiness programs and coaching
- Trainings on CSV, CSA, Data Integrity, and GMP Compliance (Corporate/Classroom/Online)
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