Computer System Validation & Computer Software Assurance
BiggsB plans, executes and modernizes computer system validation (CSV) for regulated organizations. We apply risk-based methods, including computer software assurance (CSA) and GAMP 5 principles, so validation effort matches system risk and the resulting evidence stands up to inspection.
Discuss Your ProjectWho this is for
- Pharmaceutical, biotech and medical device companies implementing or upgrading GxP systems
- Software and cloud providers whose products are used in GxP environments
- Quality and IT teams with validation backlogs or legacy, document-heavy methods
- Organizations validating AI-enabled or SaaS platforms for the first time
When clients call us
- A new GxP system, cloud migration or major upgrade is scheduled
- An audit or inspection found gaps in validation or data integrity
- Validation is slowing releases and the team wants a risk-based approach
- You need to demonstrate 21 CFR Part 11 or EU Annex 11 compliance to a customer
What the engagement covers
- Validation strategy and validation master planning
- Risk-based validation using CSA and GAMP 5 principles
- 21 CFR Part 11 and EU Annex 11 assessments
- Requirements, risk assessment, test planning and execution oversight
- Validation of SaaS, cloud and AI-enabled systems
- Validation lifecycle management and periodic review
Deliverables
- Validation plan and risk assessment
- Requirements and traceability documentation
- Test protocols, executed evidence review and summary report
- Part 11 / Annex 11 compliance assessment
- Audit-ready documentation model your team can reuse
How we approach it
- Step 1
Scope by risk
Agree intended use and critical functions so effort follows patient, product and data risk.
- Step 2
Plan
Set the validation strategy, deliverables and acceptance criteria up front.
- Step 3
Execute
Run or oversee testing with your team and vendors, resolving deviations as they arise.
- Step 4
Sustain
Leave a maintainable change-control and periodic-review model in place.
Service boundaries. We provide validation consulting and execution support. Final approval of validated status remains with your quality unit.
Questions about CSV & CSA
How does BiggsB support validation and quality teams?
We can lead a validation program, fill specific roles such as validation lead or reviewer, or coach your team in risk-based methods. Our practitioners work inside your quality system rather than replacing it.
What is the difference between CSV and computer software assurance?
Computer software assurance (CSA) is a risk-based way of approaching validation that focuses effort on features that affect product quality, patient safety and data integrity, rather than generating uniform documentation for every function.
How should we prepare for a validation project?
Clarify the system's intended use, identify the business and quality owners, gather vendor documentation, and confirm which records and signatures are regulated. That preparation makes scoping faster and more accurate.
Next step
Discuss your csv & csa project
Tell us what you are trying to achieve. A senior practitioner will reply to discuss scope, timing and whether BiggsB is the right fit.