CSV and CSA validation consulting for biotech
Risk based validation strategy, validation plans, URS/FRS, IQ/OQ/PQ, traceability, summary reports, periodic review and change control, aligned with 21 CFR Part 11 and GAMP 5.
Moving from CSV to CSA
Computer software assurance scales validation effort to risk, so a small biotech team spends its time where it matters. Read the CSV to CSA guide.
What stays the same under Part 11
Audit trails, unique logins, electronic signatures and record controls still apply.
Risk based validation strategy
System inventory, GAMP category and a risk based approach for each system.
Deliverables
Validation plan, URS and FRS, risk assessment, IQ, OQ and PQ, test scripts, trace matrix and summary report.
Periodic review and change control
Periodic review of validated systems with a report, and change control that keeps the validated state.
Prices
| Package | Scope and deliverables | Timeline | Flat price |
|---|---|---|---|
| CSA Risk Assessment | System inventory and GAMP category, risk based CSA approach for one system | 1 to 2 weeks | $5,000 |
| Validation Package: SaaS Cat 3 to 4 | VP, URS/FRS, risk assessment, test scripts, trace matrix, VSR | 4 to 6 weeks | $18,000 |
| Periodic Review | Periodic review of one validated system with report | 1 week | $3,000 |
Each package lists what is out of scope. Anything beyond bills at the rate card or converts to a change order at a pre stated price.
FAQ
- What is the difference between CSV and CSA?
- CSA is the FDA approach that scales validation effort to risk to patients and product quality. Low risk functions can use unscripted testing and vendor evidence. CSV is the broader discipline; CSA is a leaner way to do it.
- Does Part 11 still apply under CSA?
- Yes. Audit trails, unique logins, electronic signatures and record controls still apply. CSA changes how much testing you document, not those controls.
- Can you rewrite our validation SOPs for CSA?
- Yes. We update the validation SOP, risk assessment template and test approach so they match the guidance.
- Can you take over an existing validation package?
- Yes, starting with a gap review of the current documentation.