TRUQORE ADVISORY, CONSULTING AND TECHNICAL SERVICES

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We help organisations interpret and implement regulatory requirements in a clear, practical, and sustainable manner.

How we support:

• Translating complex regulations into workable processes
• Supporting inspection readiness and audit preparation
• Strengthening quality and compliance governance
• Reducing regulatory and operational risk
• Building a strong compliance culture

We assess and strengthen data integrity across paper-based and electronic systems in line with global regulatory expectations.

How we support:

• Comprehensive data integrity audits
• Identification of gaps in data accuracy, security, and traceability
• Strengthening ALCOA+ principles across systems and processes
• Improvement of documentation and record management
• Inspection readiness support

We support informed business decisions by identifying quality, compliance, and regulatory risks during acquisitions, partnerships, and investments.

How we support:

• Quality and compliance risk assessments
• Review of systems, processes, and documentation
• Data integrity and validation readiness evaluation
• Clear risk reporting and recommendations

We conduct structured, risk-based audits across manufacturing, laboratory, and support functions.

How we support:

• GMP and GxP compliance audits
• System and process evaluations
• Identification of regulatory and operational gaps
• Practical, actionable audit reports

We provide end-to-end validation and qualification services to ensure systems and processes perform reliably in regulated environments.

How we support:

• IQ, OQ, PQ for equipment and systems
• Computer System Validation (CSV / CSA)
• Risk-based validation strategies
• Validation documentation and execution
• Change control and re-validation support

We support thorough and compliant investigations that identify true root causes and prevent recurrence.

How we support:

• Deviation, OOS, OOT, and incident investigations
• Structured root cause analysis
• CAPA definition and effectiveness checks
• Trend analysis and regulatory support

We help organisations respond to regulatory observations with clarity, confidence, and compliance.

How we support:

• Inspection observation and warning letter responses
• Remediation planning and execution
• Alignment with regulatory expectations
• Support during health authority interactions

We assess and improve the effectiveness of Quality Management Systems beyond basic compliance.

How we support:

• QMS maturity assessments
• Process and governance gap analysis
• Benchmarking against industry best practices
• Continuous improvement roadmaps

We help organisations strengthen QC operations to ensure reliable testing and compliance.

How we support:

• QC process and laboratory practice reviews
• Data integrity strengthening in QC environments
• Investigation and error reduction support
• Audit and inspection readiness

We provide hands-on QA support to build sustainable quality oversight and governance.

How we support:

• QA process strengthening and governance support
• GxP guidance and best practices
• Training and capability building
• Inspection readiness and continuous improvement