Security and data integrity
A verification record you can hand to an inspector.
WLTR is built around the data integrity expectations regulated labs are inspected against: attributable actions, original records that cannot be altered, and a complete trail from instrument export to approved result.
Built-in controls
Every value traces back to its source.
Immutable source data
Raw instrument text is captured at upload, hashed with SHA-256, and preserved unchanged. Every downstream value traces back to that original record.
Readiness gates and frozen methods
Readiness validations run before every computation, and method configurations are frozen once results exist, so historical results never shift.
The right data in the right place
WLTR tracks run types, so verification samples such as the ICV can never silently enter a calibration curve.
Role-separated sign-off
Calibration records are approved through role-separated QA review with a named approver, and every action is kept on a permanent audit timeline.
ALCOA+ alignment
How WLTR maps to the data integrity principles regulators use.
| Principle | What inspectors expect | How WLTR supports it |
|---|---|---|
| Attributable | Every action tied to a named person. | Named users, role-based access and a named approver on every record. |
| Legible and enduring | Records readable for their full retention period. | Original instrument text preserved alongside the computed evaluation. |
| Contemporaneous | Data recorded when the work is done. | Source files captured and hashed at upload, before analysis begins. |
| Original | The first capture of the data, or a certified copy. | Immutable source record with a SHA-256 hash for every upload. |
| Accurate and complete | No silent changes, exclusions or omissions. | Readiness gates, run-type checks and a permanent audit timeline. |
| Consistent | Same process, same result, every time. | Deterministic evaluation against configured acceptance criteria. |
21 CFR Part 11
Designed for labs that work under Part 11.
Labs that produce records for FDA submissions must show their electronic records are trustworthy and their signatures are controlled. WLTR provides the record-level controls those labs look for, including audit trails, named approvals and protected original records. Validating WLTR for its intended use within your quality system remains your lab’s responsibility, and we support that process with documentation on request.
Questions
Frequently asked questions
Is WLTR 21 CFR Part 11 compliant?
Part 11 compliance applies to how a regulated lab validates and operates its systems, not to software alone. WLTR provides the controls Part 11 environments rely on, including audit trails, role-separated approval and protected original records, and we support your validation with documentation.
Does WLTR alter our raw data?
No. Original instrument text is preserved unchanged with a SHA-256 hash. WLTR stores its evaluation alongside the original record.
Who can approve a calibration record?
Approval roles are configured to your SOP. Records are approved through role-separated QA review with a named approver, and every step is kept on the audit timeline.
Can we review your security documentation?
Yes. Contact us at admin@wltr.tech to request security and validation documentation for your evaluation.
Next step
See the audit trail on your own data.
Bring a recent instrument export. We will walk you through the source record, the evaluation and the approval trail.