CSV & QA Support for Pharmaceutical Industry
We ensure our clients' computerized systems are fully compliant, validated, and audit-ready, while establishing a robust, sustainable Quality Assurance framework that mitigates risk and enhances operational excellence.
1. Computerized System Validation (CSV) Services
We provide end-to-end CSV lifecycle management, aligned with GxP (GMP, GLP, GCP), FDA 21 CFR Part 11, EU Annex 11, and ICH guidelines.
| Phase | Key Activities | Deliverables |
|---|---|---|
| 1. Planning & Specification | - User Requirements Specification (URS) Development - Risk Assessment (GAMP 5) - Validation Plan & Strategy |
- Approved URS Document<br- Risk Assessment Report - System Validation Plan (SVP) |
| 2. Design & Configuration | - Functional & Design Specifications (FS/DS) - Configuration Specification & Review - Traceability Matrix Setup |
- FS/DS Documents<br- Configuration Record<br- Initial Traceability Matrix |
| 3. Testing & Execution | - IQ/OQ/PQ Protocol Development & Execution - Test Scripts (Manual & Automated) - Requirements Traceability Verification |
- Executed Test Protocols & Reports - Defect/Discrepancy Logs<br- Updated Traceability Matrix |
| 4. Reporting & Go-Live | - Validation Summary Report<br- Go-Live/Release Recommendation<br- SOPs for System Use & Administration | - Validation Summary Report (VSR)<br- System Release Certificate - Draft SOPs |
| 5. Operational Support | - Change Management & Re-validation Support<br- Periodic Review<br- Audit Trail Review & Data Integrity Checks | - Change Control Documentation<br- Periodic Review Report<br- Data Integrity Gap Assessment |
Our CSV Differentiators:
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Data Integrity Focus: Proactive design for ALCOA+ principles.
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Cloud/SaaS Expertise: Efficient validation strategies for cloud-based LIMS, QMS, ERP, and CTMS.
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Integration Support: Validation of interfaces between critical systems (e.g., ERP to MES, LIMS to CDS).
2. Quality Assurance (QA) & Compliance Services
We build and strengthen your Quality Management System (QMS) to ensure ongoing compliance and a state of control.
| Service Area | Key Activities | Deliverables / Outcomes |
|---|---|---|
| QMS Development & Enhancement | - Gap Analysis against FDA/EU/ICH standards - SOP Development & Optimization - Training Program Implementation |
- Robust, process-based QMS - Effective, lean SOPs - Trained personnel with documented evidence |
| Audit & Inspection Readiness | - Internal Audits (GxP, Process, System) - Vendor Audit Management (CMOs, Labs, IT) - Mock FDA/MHRA Inspections - CAPA Management System Support |
- Audit Reports & Action Plans - Qualified Vendor List - Successful Regulatory Inspections - Effective Root Cause Analysis |
| Documentation & Change Control | - Batch Record & Documentation Review - Change Control Procedure Management - Management Review Support |
- Error-free submission-ready docs - Controlled, justified changes - Data-driven management decisions |
| Quality Risk Management (QRM) | - ICH Q9 Implementation - Risk Assessments for Products & Processes - Risk-Based Validation Strategies |
- Formalized QRM process - Proactive risk mitigation - Efficient resource allocation |
| Data Governance & Integrity | - ALCOA+ Assessments - Data Lifecycle Mapping - Governance Policy Development |
- Reliable, trustworthy data - Compliance with FDA & EMA data integrity guidance |
Our QA Differentiators:
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Proactive Compliance: Moving from reactive fixes to a predictive quality culture.
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Operational Integration: Embedding QA into manufacturing, clinical, and supply chain operations.
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Metrics & KPIs: Implementing meaningful quality metrics for management review.
How Our Integrated CSV & QA Support Benefits You
| For Start-ups & Virtual Companies | For Established Companies |
|---|---|
| ✓ "Right-Sized" Compliance: Avoid over- or under-validation. Build a scalable QMS from the ground up. ✓ Cost Efficiency: Access expert resources without full-time hires. Accelerate time-to-IND/NDA. ✓ Investor/Partner Confidence: Due diligence-ready systems and documentation. |
✓ Remediation & Modernization: Fix legacy system or data integrity issues. Move to modern cloud platforms. ✓ M&A Integration: Harmonize systems and QMS post-acquisition. ✓ Continuous Improvement: Optimize existing QMS for efficiency and effectiveness. |
Target Systems & Processes We Support
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Manufacturing: ERP, MES, SCADA, CMMS, LIMS
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Laboratory: CDS, LIMS, ELN, SDMS
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Clinical: CTMS, EDC, eTMF, RTSM
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Quality: eQMS (Document Management, Training, CAPA, Audits, Complaints)
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Regulatory: RIMS, Submission Publishing Tools
Why Partner With Us?
We are not just consultants; we are your strategic compliance partners. We combine deep regulatory knowledge with practical, hands-on industry experience to deliver compliant, efficient, and sustainable quality and validation outcomes that protect your product and your patients.
Let's discuss tailoring this support to your specific needs.