Computer system validation (CSV) is documented evidence that a computerized system does what it claims to, consistently, and it is the sponsor's responsibility, not something a vendor completes on the sponsor's behalf. This page covers what CSV actually needs and what Capture provides to support your own validation and UAT.
Free sandbox · No credit card · 21 CFR Part 11 aligned
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Shared
responsibility: software provider and sponsor both have a role
Field-level
audit trail: timestamp, user, old value, new value, reason
2-step
e-signature verification: OTP-confirmed signer, then countersignature
Enterprise
tier includes documentation to support sponsor validation and UAT
The concept
Computer system validation means documenting that a system performs as intended for its specific, intended use, consistently and reproducibly. It is not a certificate a vendor hands you. It is evidence your own quality team assembles: intended use, risk assessment, and testing that the system does what your SOPs say it should, for how your study specifically uses it.
Meaning of signature
I have reviewed this adverse event and confirm the assessment of seriousness, severity and causality.
Signer
Dr. A. Ozola, PI
Password
••••••••••
What to check
Field-level history on every record: timestamp, user identity, old value, new value and reason for change, not modifiable from the UI.
OTP-verified participant signature and password-reauthenticated investigator countersignature, each cryptographically linked to the document content at signing time.
Researcher, site coordinator and admin roles, with PII segregation and row-level security enforcing what each role can see.
Forms move through a draft-to-approved lifecycle; only approved forms reach the live casebook.
Enterprise customers get documentation and implementation assistance to support their own validation and UAT process.
Who does what
Before you switch
Free sandbox to run your own UAT scripts against, no credit card required.
Capture is not "CSV compliant" as a label. It gives you a stable, audited system and, on Enterprise, documentation to support your own validation; the validation exercise itself is yours to run.
Sandbox and production environments are separate from the start, so validation testing does not touch live data.
Bring an existing validated workflow's documentation approach across; the underlying controls (audit trail, e-signatures, RBAC) are the same shape.
Email support, typically under 24 hours, plus training and implementation assistance on Enterprise.
No credit card, no sales call. Bring your own test scripts.
CSV is documented evidence that a computerized system performs consistently and as intended for its specific use. It is assembled by the system's user (the sponsor), not delivered as a one-time certificate from a vendor.
No software is validated in the abstract; validation is study- and use-specific and is the sponsor's responsibility. Capture provides a stable, audited system and, on Enterprise, documentation to support your own validation and UAT.
They are related but distinct. SOC 2 is an independent audit of a provider's own controls. Its current status is not published on our marketing site; confirm directly with us if that is a hard requirement for your program.
Enterprise customers receive documentation, training and implementation assistance to support their own validation and UAT process.
Part 11 sets the rules for electronic records and signatures. CSV is the validation process that proves your specific system, as you use it, actually meets them. See our Part 11 checklist for the rules themselves.
Yes. The free sandbox includes every feature with sample data, no credit card and no time limit.
Keep exploring
21 CFR Part 11 compliance checklist
The electronic records and signature rules CSV is meant to prove.
Audit trail software
The field-level history a validated system needs underneath it.
Electronic signatures
The two-step verification behind every signature.
ALCOA+ data integrity checklist
The data-integrity principles a validated system supports.
Query management software
How the audit trail records every query resolution.
No credit card, no sales call. Bring your own test scripts.