GXP Audit Services
Process and Product Validation
Process and Product Validation
GxP assessment and process establishment
Perform audits for established GxP set ups
Define remediation strategies for any gaps
Determining regulatory inspection readiness
Perform RCA and CAPA for Regulatory audit findings
Due diligence audit (Auditing customer’s supplier)
Process and Product Validation
Process and Product Validation
Process and Product Validation
Equipment Commissioning, Qualification and Validation
Computer System Validation (CSV)
Progressive software validation as per NCA regulations
Retrospective validation for existing systems
21 CFR Part 11 / Annex 11 gap analysis and remediation
Laboratory Systems Qualification (GLP)
GxP Solution Consulting
GxP Solution Consulting
GxP Solution Consulting
QMS Systems
DMS Systems
CAPA Systems
Service / Helpdesk Ticketing Systems
Training Automation Systems
QMS Remediation Services
GxP Solution Consulting
GxP Solution Consulting
SOP Gap Analysis
SOP Standardization
SOP Rationalisation
SOP Reconciliation and Optimization
SOP Integration