+91 94900 30441expert@gxphelpline.com

GxP Compliance Services

Practical, Defensible, Scalable Solutions for Life Sciences Compliance

GxP Consulting

Strategic guidance for implementing and maintaining GMP, GCP, and GLP compliance across your organization.

Scope

  • GMP facility qualification and validation
  • GCP clinical trial compliance
  • GLP laboratory operations
  • Quality system assessments
  • Gap analysis and remediation

Deliverables

  • Compliance roadmaps
  • SOPs and policies
  • Training programs
  • Risk assessments
  • Regulatory submissions support

Computer System Validation (CSV) & Computer Software Assurance (CSA)

Comprehensive validation services for computerized systems in regulated environments, following GAMP 5 and risk-based approaches.

Scope

  • Validation master planning
  • Risk-based validation strategies
  • IQ/OQ/PQ protocols and execution
  • Legacy system assessments
  • Periodic review programs

Deliverables

  • Validation plans and reports
  • Test protocols and scripts
  • Traceability matrices
  • Risk assessments (FMEA)
  • Validation summary reports

Data Integrity & 21 CFR Part 11

Ensuring ALCOA+ principles and electronic records compliance across all data lifecycle stages.

Scope

  • Data integrity assessments
  • Part 11 compliance audits
  • Audit trail review procedures
  • Electronic signature implementation
  • Data governance frameworks

Deliverables

  • Data integrity policies
  • Part 11 compliance matrices
  • Audit trail SOPs
  • Training materials
  • Remediation action plans

Quality Management Systems (QMS) & eQMS

Implementation and optimization of paper-based and electronic quality management systems.

Scope

  • QMS design and implementation
  • eQMS software validation
  • Document control systems
  • Change control processes
  • CAPA management

Deliverables

  • QMS manuals
  • eQMS validation packages
  • Document templates
  • Process workflows
  • Training and SOPs

Digital & Automation Validation

Validation services for cloud systems, AI/ML applications, RPA, and digital transformation initiatives.

Scope

  • Cloud platform validation (AWS, Azure, GCP)
  • AI/ML algorithm validation
  • RPA bot validation
  • SaaS application assessments
  • Digital twin validation

Deliverables

  • Cloud validation strategies
  • AI/ML validation reports
  • Supplier assessments
  • Security and compliance reviews
  • Continuous compliance frameworks

Audit & Inspection Support

Preparation, defense, and remediation support for regulatory inspections and internal audits.

Scope

  • Pre-inspection readiness assessments
  • Mock audits
  • On-site inspection support
  • Response to 483s and warning letters
  • CAPA investigation and implementation

Deliverables

  • Audit readiness reports
  • Gap remediation plans
  • Response documentation
  • CAPA tracking
  • Post-inspection reports