Computer System Validation (CSV) Services for Pharma & Biotech
GAMP 5-compliant validation from experts with 23+ years at Pfizer and 13 years at Veeva. Practical, risk-based validation that protects your compliance and accelerates your business.
The Validation Challenge
Every pharmaceutical and biotech company faces the same compliance burden: ensuring computerized systems are validated and inspection-ready. Yet most struggle with:
- FDA inspection anxiety with unvalidated systems in production
- Validation backlogs growing faster than internal resources
- Cloud and SaaS confusion about validation requirements
- Outdated documentation from systems deployed years ago
- No internal CSV expertise to guide validation strategy
We provide the expertise to get your systems validated right—practical, risk-based validation that passes inspection and supports your business goals.
Our CSV Services
Three proven engagement models to meet your validation needs
CSV Assessment & Roadmap
$15K-$25K | 2-3 weeks. Comprehensive system inventory, gap analysis, risk classification per GAMP 5, and prioritized remediation roadmap. Perfect for understanding where you stand before an audit.
System Validation Execution
$40K-$120K | 6-12 weeks. Complete IQ/OQ/PQ validation for individual systems. Includes URS, VP, protocols, execution, and summary report. Inspection-ready documentation that stands up to scrutiny.
CSV Program Development
$75K-$150K | 8-16 weeks. Build internal validation capability with SOPs, Validation Master Plan, template library, and staff training. Enables your team to validate systems independently.
Our Validation Approach
We combine regulatory expertise with practical implementation experience to deliver validation that works in the real world.
Risk-Based Methodology
Following GAMP 5 Second Edition principles, we focus validation effort where risk is highest. Not every system needs the same level of rigor—we help you make defensible, risk-based decisions that satisfy regulators without over-validating.
Practical Documentation
Our validation packages are thorough but practical. We create documentation that inspectors expect to see, written in clear language that your team can maintain. No unnecessary documentation—just what's needed to demonstrate compliance.
Modern Systems Expertise
We validate modern cloud, SaaS, and AI/ML systems using current regulatory thinking. Our team understands how to apply traditional validation principles to cloud platforms, configurable SaaS applications, and emerging technologies like generative AI.
Veeva Vault Specialization
With 13 years of Veeva experience including roles as Practice Director for Vault Quality and RIM, we bring unique vendor-side and client-side perspective. We understand Veeva's validation approach and can accelerate your QMS, QualityDocs, and CTMS validation.
Systems We Validate
Our validation expertise spans the full spectrum of GxP computerized systems used in pharmaceutical, biotech, and medical device companies.
Quality Management Systems
Veeva Vault QMS, MasterControl, ETQ, TrackWise, and other electronic quality systems for CAPA, change control, deviations, and document management.
Learn moreDocument Management
Veeva Vault QualityDocs, Documentum, SharePoint, and custom DMS for controlled document lifecycle, training records, and batch records.
Learn moreLaboratory Systems
LIMS and ELN platforms including LabWare, STARLIMS, Benchling, Dotmatics, and custom laboratory data management systems.
Learn moreManufacturing Execution
MES platforms from Rockwell, Siemens, Emerson, and custom manufacturing systems for batch execution, equipment monitoring, and genealogy.
Learn moreClinical Trial Systems
Veeva Vault CTMS, Medidata EDC, Oracle Clinical, and other systems for study management, safety reporting, and regulatory submissions.
Learn moreEnterprise Systems
SAP for life sciences, NetSuite, Coupa, and other ERP and procurement systems that handle GxP data or support regulated processes.
Learn moreCloud & SaaS Platforms
Applications hosted on AWS, Azure, GCP, and SaaS platforms. We apply modern validation approaches including vendor assessment and critical function testing.
Learn moreAI & ML Systems
Custom AI models and machine learning systems used in drug discovery, quality prediction, and manufacturing optimization in GxP environments.
Learn moreRegulatory Compliance Framework
Our validation services ensure compliance with all relevant regulatory standards and guidance documents.
FDA 21 CFR Part 11
Electronic records and electronic signatures requirements for FDA-regulated industries.
EU Annex 11
European Medicines Agency computerized systems requirements for pharmaceutical quality systems.
GAMP 5 Second Edition
Good Automated Manufacturing Practice guide for validation of automated systems.
ICH Q9
Quality Risk Management principles applied to system validation and ongoing maintenance.
ISO 13485
Medical device quality management system requirements for software validation.
Computer Software Assurance
FDA's modern, risk-based approach to software validation emphasizing critical thinking over documentation.
Your Validation Team
Led by validation experts with decades of experience at Pfizer and Veeva Systems.
Amie Harpe
CSV Practice Lead
- • 23 years at Pfizer - Quality Operations and Digital Solutions
- • Deployed DMS to 65 manufacturing sites, 22,000 users
- • Led Veeva QMS implementation for change control
- • PMP, SAFe Product Owner, Lean Six Sigma Green Belt
Pesh Joshi
Veeva & Regulatory Systems
- • 13 years at Veeva Systems - Senior Consultant to Practice Director
- • Practice Director for Vault Quality (QualityDocs, QMS, Training)
- • Practice Manager for RIM Vault (regulatory submissions, eCTD)
- • 20 years total in life sciences software implementation
Frequently Asked Questions
Ready to Get Compliant?
Schedule a free CSV assessment call to discuss your validation needs. We'll help you understand your gaps, estimate effort, and chart a path to inspection readiness.
Schedule a Free CSV Assessment Call