Compliance, Audit & Validation Service
GxP Audit Services:
- GxP assessment and process establishment
- Performing audit for established GxP set ups and proposing multiple mitigation strategies
- Determining inspection readiness
- Performing RCA and CAPA for a Regulatory audit finding and evaluating the efficiency of CAPA for facing / submitting a Regulatory audit
- Performing target audit (Molecule /function-specific audit)
- Due diligence audit (Auditing customer’s supplier)
GxP audit services include:
- Good Manufacturing Practice (GMP) audit services
- cGMP audits
- GMP compliance assessment
- GMP gap analysis
- GAMP audit Services
- GxP risk assessment
- Good Laboratory Practice (GLP) audit services
- Good Clinical Practice (GCP) audit services
- Audit trail adequacy assessment
- Response to Regulatory audit report
- Audit report preparation/submission
QMS Remediation Services:
- SOP Gap Analysis
- Remediation
- SOP Preparation
- Training
Process and Product Validation Services:
Computer System Validation (CSV)
- Progressive software validation as per health authority guidelines
- Accurate methodologies for effective validation
- Pre-designated quality gates to minimize re-works
- Validation throughout the lifecycle
- Validation certificate
- Data security and compliance
Retro Validation
- Retrospective validation for existing systems
- Analysing gaps in existing documentation
- Expert validation support to fill the gaps
- Validation certificate
Other Engagements
- GxP assessment, ERES (Electronic Record/Electronic Signature) assessment
- CSV (Computer System Validation), Audit trail adequacy assessment
- BCM (Business Continuity Management) & DR (Disaster Recovery) adequacy assessment
- Vendor audit services - Vendor audit and qualification assessment
- Manufacturing facility audit services
GxP Solution Consulting:
CAPA Systems
- Route-cause analysis for errors
- Corrective Action
- Preventive Action
- In-detail documentation
- Document Automation
QMS Systems
- SOP automation
- Accurate Documentation
- GxP workflow enabled
- No manual-driven signatures
HR & Training Automation Systems
- Training Automation
- Accurate Documentation
- GxP workflow Integrated
Service / Helpdesk Ticketing Systems
- SAS Offering
- Service/helpdesk ticketing automation
- GxP workflow integrated