Scale Your Validation Team with CSV & CSA Professionals
Access experienced Computer System Validation (CSV) and Computer Software Assurance (CSA) professionals to support projects, fill resource gaps, and strengthen your validation team.
cGMP Consulting provides flexible contract support for pharmaceutical, biotechnology, medical device, and other regulated life sciences organizations.
Need one experienced professional or a full team for a major initiative? Our validation experts scale to fit the work and integrate seamlessly with your staff.
Individual Resources
Experienced professionals to fill specific CSV and CSA project needs.
Project
Support
Additional validation resources for implementations, remediation, upgrades, and other initiatives.
Embedded
Support
Professionals who work alongside your internal quality, validation, engineering, and IT teams.
Scalable
Teams
Expand or adjust validation resources as project requirements change.
CSV & CSA Expertise for Regulated Systems
Not sure whether your system calls for full computer system validation or a risk-based CSA approach? We help you determine the right path your systems.
Computer System Validation (CSV)
Full lifecycle validation services built on GAMP 5 methodology, covering everything from initial strategy through retirement, so your computerized systems become and stay compliant.
- Validation strategy and planning (GAMP 5-aligned)
- Requirements and specifications development
- Risk assessments and criticality analysis
- IQ/OQ/PQ execution and testing support
- Validation documentation and summary reports
- Data integrity assessments (ALCOA+)
- Legacy system and spreadsheet validatio
- Gap remediation and periodic/ongoing review
- 21 CFR Part 11 & EU GMP Annex 11 compliance support
Computer Software Assurance (CSA)
Risk-based assurance, backed by critical thinking, that meets FDA’s Computer Software Assurance expectations, cutting unnecessary scripted testing while strengthening product, patient, and data integrity risk coverage.
- CSA strategy and implementation roadmap
- Assessment determining the level of effort commensurate with the risk.
- Assurance testing (scripted and unscripted approaches)
- CSV-to-CSA transition support
- Documentation burden reduction
- Cloud and SaaS vendor qualification support
- Audit and inspection preparedness
- Team training and change management
Why Choose cGMP Consulting?
The Right Resource for the Work
Successful validation projects require professionals with the right experience for your systems, regulatory environment, project requirements, and internal team.
cGMP Consulting provides organizations with experienced validation professionals who align with the specific expertise and support each project requires.
1.
Industry Experience
Professionals with experience supporting pharmaceutical, biotechnology, medical device, and other FDA-regulated life sciences environments.
2.
Technical Alignment
Resources aligned with your systems, technologies, validation requirements, and project scope.
3.
Flexible Engagements
Support ranging from individual validation professionals to larger project teams, short and long term.
4.
End-to-End Documentation
Complete and audit-ready documentation at every stage.
5.
Scalable Support
Add or adjust resources as project requirements, priorities, and timelines change.
Get the Validation Resources Your Project Needs
1.
Tell Us What You Need
Share your project, timeline, technical requirements, and resource gaps.
2.
Identify the Right Expertise
Align the required experience and capabilities with your specific validation needs.
3.
Add Resources to Your Team
Bring in the right professionals to support your project and existing team.
4.
Scale as Requirements Change
Adjust resources as project scope, timelines, and priorities evolve.
Industry Expertise
Computer System Validation
A practical, risk-based guide to Computer System Validation (CSV) for FDA-regulated companies, covering GAMP 5, CSA, the V-model, and data integrity.
