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The compliance layer

Built so the audit is the easy part.

The same signatures, permissions, approvals, and audit trail run quietly beneath every DLBD application. The controls travel with the work, so there is less to reconstruct when an auditor arrives.

Built to adapt to your regulatory regime: 21 CFR Part 11 · ISO 17025 · ISO 13485 · ISO 9001 · GxP

SOC 2 in progress — ask us about our current controls.

21 CFR Part 11

The clauses, mapped.

§11.10(a)
Validation

Built to support your system validation for accuracy, reliability, and consistent performance.

§11.10(b)
Record copies

Accurate, complete copies of records in human-readable and electronic form.

§11.10(c)
Record retention

Immutable history, plus approved retention policies with signed disposal at end of life.

§11.10(d)
Access control

Access limited to authorized individuals: roles you define, single sign-on, and MFA.

§11.10(e)
Audit trail

Secure, computer-generated, time-stamped audit trails with reason-for-change.

§11.10(k)
Change control

Controls over documentation and change to system records and procedures.

§11.50
Signature manifestations

Signed records show signer, date/time, and the meaning of the signature.

§11.70
Signature linking

Signatures are bound to their records so they cannot be excised or copied.

Audit trail

The answer is already there.

When someone asks who changed a record and why, you can answer without calling a meeting. The history is complete, attributable, and ready to review.

Who, what, when, on every record that matters The full context of every change, captured for you Records are never silently deleted or overwritten A reason-for-change on every signed edit (§11.10(e))
vapor.dlbd.us/results/R-8842
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JM

Audit trail · Result R-8842

immutable
PS
Priya Shah created14 Jun · 08:41
Result R-8842 · As 0.21 ppm
  1. 1
    Open any record
    Every record that matters carries a history that cannot be edited after the fact.
  2. 2
    Who, what, when
    Each change is attributed and time-stamped for you, with nothing to log by hand.
  3. 3
    The reason, on the record
    The §11.10(e) context an auditor asks for is already written before anyone asks.
Electronic signatures

Friction where it counts. Nowhere else.

Routine work stays routine. Stronger signing steps appear only when the decision carries real risk, so control does not become password fatigue.

Routine work keeps moving

Everyday approvals stay fast while remaining attributable and ready for review.

  • Result verification
  • Batch verification
  • Instrument data approval
High-risk decisions get stronger proof

When a decision carries real consequence, the evidence is strong enough to defend it later.

  • Close a CAPA
  • Approve a document revision
  • Unsign a record
Configurable approvals

Fit the process to your regime.

Approval paths can change with the organization, product, or market. Adapt without buying another system or waiting on a custom release.

QA Director CEO
Data isolation

Grow without crossing the lines.

Support more sites, business units, or clients on the same platform while keeping every organization’s records firmly separate.

Greenfield
isolated
Nordic
isolated
Apex
isolated
Identity

Sign in the way your IT team already works.

Sign in through the identity system your IT team already runs, and require it organization-wide. Users and their roles provision from that same system, so a new hire or a departure is handled where your IT team already handles it. Multi-factor authentication is built in and enforceable, and any integration you connect uses scoped credentials that write to the same audit trail as everyone else.

Single sign-onMulti-factor, enforceableRoles you defineScoped API credentials

Bring your auditor.

See the audit trail, the signature manifest, and the approval chain in the live demo.

See the demo Talk to us