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How the platform's validation approach affects your CSV burden.
Compliance is built into the platform's architecture rather than added through configuration. This section covers what's validated at the platform level, and what your QA team still validates.
Compliance is enforced by the node architecture.
Traditional systems prove compliance by validating a configuration, then re-validating on every change. CMS Life Sciences builds compliance into the node architecture, so validation is continuous and built in rather than a manual re-do on every release.
- Every node maps to an ALCOA+ principle — see the full mapping at /compliance
- A change to the system is itself readable and auditable
- Reason-for-change is captured structurally, not by policy alone
- The audit trail is immutable and append-only
- Data is available for audits via surface views and CSV export — not a data-pull request to us
- Access is gated by role, so every screen a user sees is already within their authorized scope
Every mutation requires a categorized reason.
When a user corrects a record, the platform requires a structured reason before the change is accepted — the same categories your CSV process already recognizes.
| Category | When it applies |
|---|---|
| Correction of error | Fixes a data-entry or process mistake. |
| Additional information | Adds detail that wasn't available at the time of entry. |
| Protocol amendment | Reflects a change to the study protocol. |
| Sponsor request | Made at the sponsor's direction. |
| Regulatory requirement | Required to meet a regulatory obligation. |
| System-generated | Automated correction (e.g. reconciliation), still attributable. |
| Other | Requires a free-text note — the only category that does. |
Reports available to auditors today.
These reports exist in the running application, not as mockups, and compose into a single exportable audit trail.
Chain-of-custody report
Composes audit events, transfers, returns, and disposition into one timeline per sample, from receipt through final disposition.
Audit trail
Immutable, attributable event log — every event tagged with the specific ALCOA+ principle it satisfies, filterable by user and action type, and exportable to CSV for your auditors.
Ethics & consent approvals
Ethics-approval tracking with expiry alerts, satisfying ICH GCP consent-gating requirements.
Effort & capacity reporting
Manager-level effort broken down by workflow stage (reception, transfer, return, reconciliation, disposition) — useful evidence for staffing and workload review during an inspection.
Regulatory standards covered by the platform.
21 CFR Part 11
Digital records, immutable audit trails, and e-signature-ready workflows.
GxP
Structured reason-for-change captured on every data mutation.
ICH GCP
Ethics-approval tracking with expiry alerts and consent gating.