CSV Program Development
Build internal validation capability that scales with you
Investment
$75,000 - $150,000
Timeline
8-16 weeks
Outcome
Complete CSV Program
Build Your CSV Program from the Ground Up
Stop relying on consultants for every validation. Build internal capability that lets your team execute independently.
Our CSV Program Development package provides everything you need to establish a complete validation program - SOPs, templates, procedures, and training based on 65+ site deployment experience.
This is not just templates. It is a working system built on modern GAMP 5 Second Edition and CSA principles.
What You Get
Key Templates & Documentation
User Requirements Specification Template
Capture business and regulatory requirements with a structured URS template that ensures complete traceability to qualification testing.
IQ/OQ/PQ Protocol Templates
Risk-based Installation, Operational, and Performance Qualification templates with example test cases across different GAMP categories and system types.
Validation Playbook
Step-by-step guidance for executing validations from planning through periodic review. Includes decision trees, checklists, and real-world examples from 65+ deployments.
Who This Is For
Scaling Biotechs
Building QA capability from scratch as you grow from pre-commercial to commercial operations.
Companies Transitioning to Internal Capability
Moving from CRO-dependent validation to internal execution to reduce costs and increase control.
Organizations Preparing for Commercial Launch
Establishing compliant validation programs ahead of commercial operations and regulatory scrutiny.
Teams Validating Multiple Systems
Need to validate several GxP systems efficiently with a consistent, repeatable approach.
What Makes This Different
Not just templates - a complete, working validation program built on real-world experience.
Working System, Not Just Templates
Complete SOPs, procedures, and playbooks that work together as an integrated validation management system.
Learn moreTraining for Independent Execution
Comprehensive training program so your team can execute validations without ongoing consultant dependency.
Learn moreBased on 65+ Site Deployment Experience
Built from real-world pharmaceutical deployment experience, not theoretical compliance frameworks.
Learn moreModern Approach
Based on GAMP 5 Second Edition and Computer Software Assurance principles for efficient, risk-based validation.
Learn moreScalable and Flexible
Framework adapts to different system types, GAMP categories, and organizational maturity levels.
Learn moreInspection-Ready Documentation
All documentation structured to withstand FDA, EU, and other regulatory authority scrutiny.
Learn moreProgram Development Process
Weeks 1-2: Requirements & Assessment
Understand your organizational structure, system landscape, regulatory requirements, and validation maturity level.
Weeks 3-6: SOP Development
Create customized SOPs for system validation, change control, periodic review, vendor qualification, and deviation management.
Weeks 7-10: Template Library Creation
Develop complete template library with examples across different GAMP categories and system types.
Weeks 11-14: Validation Master Plan
Document comprehensive validation strategy, system inventory, risk assessments, and ongoing maintenance approach.
Weeks 15-16: Training & Knowledge Transfer
Train QA staff and system owners on executing the CSV program independently with hands-on workshop sessions.
Complete Deliverables
Return on Investment
Building internal CSV capability delivers significant long-term value compared to ongoing consultant dependency.
Typical Consultant Model
- $40K - $120K per system validation
- Ongoing dependency for each new system
- Limited knowledge transfer
- Less control over timing and approach
Internal Capability Model
- One-time investment of $75K - $150K
- Execute unlimited validations internally
- Complete knowledge transfer to your team
- Full control over validation approach and timeline
Break-even after 2-3 system validations
Most organizations validate 5-10+ systems over their first few years, making internal capability significantly more cost-effective.
Build Your CSV Program
Stop relying on consultants for every validation. Build internal capability that scales with your organization.
Schedule a Consultation